Vol. 132, No. 24 — June 13, 1998

Fees to be Paid in Respect of Medical Devices Regulations

Statutory Authority

Financial Administration Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

It is Government policy to implement user charges for services that provide identifiable recipients with direct benefits beyond those received by the general public. The Financial Administration Act confers the authority to implement this cost recovery initiative. The fees have been developed within the framework of the Treasury Board Policy entitled Cost Recovery and Charging Policy (April 1997).

The objectives of cost recovery are to shift the cost of government activities which benefit specific individuals or firms from the taxpayer in general to those who benefit most directly from these activities or, where a program is in place to regulate an activity because of the increased social costs which arise from it, to shift the cost of these activities to those who generate them. It is also intended to promote more business-like and equitable management of government programs and facilitate improvements in the delivery of specific cost-recovered services.

The purpose of the proposed Regulations is to revoke the current fees Regulations for medical devices and prescribe new client fees for:

— the service provided by the Therapeutic Products Programme (TPP) for the examination of an application for a medical device licence, (see footnote 1)

— the right or privilege to import or sell a medical device in Canada conferred by granting a medical device licence to manufacturers of class II, III and IV medical devices, and

— the right or privilege to import or sell a medical device in Canada conferred by granting an establishment licence to importers and distributors of class I, II, III and IV medical devices and to manufacturers of class I medical devices who do not have a licensed Canadian importer or distributor.

In February 1991, a review of the medical devices regulatory program was initiated when the then Minister of the National Health and Welfare established the Medical Devices Review (Hearn) Committee to formulate recommendations concerning the regulation of medical devices and associated activities. This Committee was established in recognition of the increased volume and complexity of new medical devices used in health care and the need for timely availability of safe and effective devices in the next century.

The report of the Hearn Committee was released in August 1992, and received endorsement of all stakeholders. It recommended a revised approach to regulating medical devices based on the principles of risk assessment and risk management. The Hearn Committee also recommended "the considered development through appropriate consultation with stakeholders, of a cost recovery system applied selectively to defray, in part, the cost of operating an improved medical devices regulatory programme".

The Medical Devices Bureau of Health Canada, now part of the Therapeutic Products Programme (TPP), completed Phase I of its cost recovery initiative by implementing the Medical Devices Fees Regulations on January 1, 1996. In Phase I, client fees were applied to medical devices subject to a pre-market evaluation, as required under Part V of the current Medical Devices Regulations.

The proposed Fees to be Paid in Respect of Medical Devices Regulations constitute the second phase of the medical devices cost recovery initiative. Client fees will be charged for an expanded pre-market review program and a number of additional services that will be provided by the TPP as the result of proposed changes to the Medical Devices Regulations. The Medical Devices Regulations set out a system for classifying medical devices into one of four classes, class I representing the lowest risk devices (e.g. surgical instruments) and class IV representing the highest risk devices (e.g. test kit used for the detection of infectious agents such as Human Immune Deficiency Virus [HIV] and hepatitis viruses). These Regulations, which have been under development since 1992, were published in the Canada Gazette, Part I, on February 15, 1997, and are targeted to come into effect on July 1, 1998. The introduction of these fees was delayed until Phase II to allow for the implementation of the new Medical Devices Regulations.

The total cost of the direct and indirect activities related to the examination of applications for medical device licences and licensing of medical devices and establishments under the new Medical Devices Regulations is in excess of $13 million. The revenue from the three fee initiatives is expected to recover $7.7 million per year when fully implemented. The remaining costs will continue to be paid through Appropriations.

The proposed Fees to be Paid in Respect of Medical Devices Regulations will establish fees for services based on the requirements set out in the new Medical Devices Regulations and will replace the existing Medical Devices Fees Regulations.

Devices which are:

— custom-made;

— imported or sold under the special access program (emergency use);

— imported or sold for investigational testing; or

— which fall into class I

are not subject to the medical devices licensing requirements under the proposed framework and are exempted from the medical device licensing fees.

These devices have been exempted because of the low risk to the Canadian consumers in the case of class I medical devices and for public good reasons with respect to custom-made medical devices, medical devices sold under the special access program or for investigational testing.

The following establishments are not subject to the establishment licensing requirements under the proposed framework and are exempted from the establishment licensing fees:

— retailers;

— health care facilities; or

— manufacturers of class II, III or IV medical devices.

While manufacturers of class I medical devices are not subject to the medical device product licensing requirements and medical device licensing fees, they are subject to the establishment licensing requirements and establishment licensing fees, if they do not have a licensed Canadian importer or distributor.

I. Fees for Examination of Applications for Medical Device Licences

The proposed fee structure is based on the medical device licensing requirements of the new regulatory framework. Under the new framework, manufacturers must hold a medical device licence to import or sell a class II, III or IV medical device in Canada. Manufacturers of medical devices will be required to submit evidence to support safety and to indicate that effectiveness requirements have been met. The degree of information which must be submitted to provide assurance to the TPP that the safety and effectiveness requirements have been met is proportional to the class of the device. For example, class IV devices require more information to be submitted than class III devices and class III devices require more information to be submitted than class II devices.

Note that not all class III or IV licence applications are the same. To allow the fees to accommodate the content of different licence applications, the overall fee to be paid for the examination of a class III or IV medical device application is the total of the fees for the review of the different information components that must be included. This approach, similar in concept to that used for the Drug Evaluation Fees Regulations, is intended to ensure that costs are allocated fairly.

The fees are based on average costs to conduct an examination of information which must be included in common components of an application.

The fee for each data component detailed in the proposed Regulations includes both a screening fee and an examination fee. Screening is a service which determines whether the information is complete and in an acceptable form for review. If an application is rejected on screening as being inadequate for review, the examination portions of the component fees are refundable.

If an application for a class III medical device licence is preceded by an application for authorization to conduct investigational testing, the following data component of the fee schedule will not apply:

— description of the medical device and the materials used in its construction and packaging, intended use and a summary of the reported problems with the medical device in other countries.

If an application for a class IV medical device licence is preceded by an application for authorization to conduct investigational testing, the following data components of the fee schedule will not apply:

— description of the medical device and the materials used in its construction and packaging, intended use and a summary of the reported problems with the medical device in other countries; and

— risk assessment and risk reduction measures.

The TPP believes that this approach ensures that fees are not charged for work conducted under the previous authorization but also will encourage research and development of new technologies in Canada.

Medical Device Licence Amendment

There will be no fee for class II medical device licence amendments.

If a manufacturer makes a change respecting the application requirements for a class III or IV medical device, the fee payable is for screening and examining each amended data component contained in the application for amendment. In order to decrease administrative burden, there are no separate fees for administrative licence amendments. The cost of this activity will be captured by the annual product licence renewal fee.

Payment of fees

To minimize administrative costs, if the fee payable is $5,000 or less the full fee is payable at the time the application is submitted. For all applications, the portion of the fee related to screening is payable whether or not the application is accepted for review.

Fee Reduction Provisions

As with other TPP cost recovery activities, provision is made for reduced fees to prevent severe financial burden to small businesses and to minimize impact to product availability by promoting the continued introduction of low volume or low sales medical devices. Three separate fee reduction provisions are proposed. The fee reduction provisions apply to initial product licensing and annual product licensing renewal fees and as an overall cap on the annual product licence renewal fees.

The fee reduction provisions will limit the initial product licensing fee to 5 percent of the applicant's actual gross revenue from sales in Canada of the medical device during a two year period beginning on the date that the medical device is first sold in Canada.

Appeal Process

There will be a formal appeal process to facilitate the resolution of contentious cost recovery issues. The appeal process will follow the existing two level appeal process model utilized for regulatory and cost recovery activities in the TPP. The appeal process will be made available with the medical devices fees guidance documents.

Transition

Applications for the issuance of a Notice of Compliance pursuant to Part V of the current Medical Devices Regulations received prior to July 1, 1998, will be subject to the current Medical Devices Fees Regulations. Applications for the issuance of a Notice of Compliance pursuant to Part V of the current Regulations received after September 1, 1998, will be subject to the proposed new Fees to be Paid in Respect of Medical Devices Regulations.

Manufacturers of devices which are being sold in Canada when the new Medical Devices Regulations take effect will be provided a grace period to license those devices. Applications will not be accepted prior to September 1, 1998. The grace period will end on February 1, 1999, meaning that the devices must be licensed by that date. There will not be a fee for an application in respect of a medical device that on June 30, 1998, is being sold in Canada pursuant to the current Regulations in the following cases:

— a device that is subject to Part V of the current Regulations, the manufacturer of which has been issued a Notice of Compliance on or before June 30, 1998; or

— a device that is not subject to Part V of the current Regulations, the manufacturer of which has met the requirements for a device notification pursuant to Part II of the current Regulations on or before June 30, 1998. Manufacturers of medical devices subject to Part II of the current Regulations are required to notify the TPP that they are selling the product in Canada, within 10 days of first sale, and must possess evidence of the product's safety, quality and effectiveness.

An application for the issuance of a Notice of Compliance pursuant to Part V of the current Regulations that is under review by the Minister when the new Regulations come into effect will be processed as if that Part were still in force. There will not be an additional licence fee for those devices.

II. Annual Medical Device Licensing Fees

An annual fee for the right or privilege to sell a medical device in Canada will be charged to the licensees for each medical device sold in Canada. Fees will be charged at the time of the annual licence renewal in respect of the 12-month period commencing on November 1, in the year in which the fee is required to be paid.

The fee collected for this right or privilege will be used to pay for the activities performed by the TPP that relate to the administration of medical device licensing. These include a portion of the cost of post-market activities.

To reduce the impact on small manufacturers, a fee reduction provision has been proposed whereby low sales volume products are subject to a lower fee of $50 when the gross revenue of that medical device is $20,000 or less, during the licensee's previous fiscal year, based on certified financial records. In addition to the product specific fee reduction provision, there is an overall cap on the annual product licence renewal fees. The cap will limit the overall cost of annual fees to 1.5 percent of total sales of the firm.

III. Establishment Licensing Fees

The proposed establishment licensing fees are based on the requirements in the new medical devices regulatory framework. The fee to be paid is for the right or privilege to import or sell a medical device conferred by granting an establishment licence to importers or distributors of class I, II, III or IV medical devices and to manufacturers of class I medical devices who do not have a licensed Canadian importer or distributor.

A fee will be charged for each establishment in the case of an initial establishment licence application. An annual fee will be charged for the renewal of each establishment licence. The fee collected for the right or privilege to hold an establishment licence will be used to pay for the activities performed by the TPP that relate to the administration of establishment licensing. These include a portion of the cost of post-market activities. The establishment licensing fee will be charged annually in respect of the 12-month period commencing on January 1, in the year in which the fee is required to be paid. Establishment licensing fees will be implemented January 1, 2000.

Establishments engaged in the activities of distribution or importation and certain class I manufacturing establishments are subject to establishment licensing and therefore the fees. The TPP is working with industry to develop guidance on this issue.

Reinstatement of Licence

The full fee will be charged for the reinstatement of a medical device licence or an establishment licence that had been suspended.

Review

The final phase of the cost recovery implementation plan is the 1999 Phase IV review of all TPP cost recovery initiatives to determine the overall impact of cost recovery on different sectors of the drug and medical device industries and on the Canadian public. The TPP is currently defining the scope and approach to this review. As a result of this review, the existing fee Regulations will be examined to address issues identified. The review will also ensure that the TPP is consistent with Treasury Board's policy entitled Cost Recovery and Charging Policy (April 1997) as it relates to the cummulative effect of fees.

The proposed regulatory framework, as published in the Canada Gazette, Part I, in February 1997, is consistent with regulatory frameworks for medical devices in the European Union, the United States, and Australia. The implementation of harmonized regulatory requirements has provided the opportunity to begin the negotiation of Mutual Recognition Agreements (MRAs) with Canada's trading partners. MRAs are beneficial to industry and in the long term will result in regulatory efficiencies.

International Comparisons

Similar to the Therapeutic Goods Administration (TGA) in Australia, the Centre for Devices and Radiological Health (CDRH) in the United States and the Medical Devices Division of the National Institute of Health Sciences (NIHS) in Japan, the TPP's mandate is to ensure that the medical devices available in Canada are safe, effective and of high quality. Australia and Japan, two of Canada's major trading partners, recover fees for medical devices regulatory activities.

In Australia, fees and charges are payable for the registration and listing of therapeutic devices, the licensing of therapeutic goods manufacturers, and other activities controlled under the Therapeutic Goods Act, 1989. Effective July 1, 1998, the TGA will recover 100 percent of the cost of medical devices regulatory activities.

In the United States, fees for medical devices regulatory activities are not in place. However, the policy on fees in the US is different to that in Canada. There, fees are used to provide revenue to support additional activity to deliver an increased level of service, rather than to replace government funding.

The European Union (EU) system is designed not only to ensure that devices are safe and effective but also to facilitate EU-wide trade by creating a single review process that permits devices to be marketed in all member states. Under the EU system both governmental and private organizations review and approve medium and high risk devices. These are referred to as notified bodies and are privately owned and operated firms. Manufacturers pay fees to the notified body of their choice to conduct assessments of devices they would like to market.

A comparison of proposed Canadian fees and performance standards to those of the CDRH in the United States, the TGA in Australia, the NIHS in Japan and the EU are illustrated in the following table.

Jurisdiction	Fees (CAN$)	Performance standards
TPP (Canada) current fees	$125-$11,000	60 calendar days
TPP (Canada) proposed fees	$200-$15,000	15 to 60 calendar days
CDRH (United States)	nothing in place	16 months1
TGA (Australia)	$220-$35,000	120 working days
NIHS (Japan)	$175-$7,900	unable to obtain
EU	$8,000 third party contracts design review	~ 90 calendar days

¹ New Directions in Medical Device Regulation — An FDA Progress Report, 1997.

Canada's existing and proposed performance standards are the lowest in the world.

Performance Standards

This cost recovery initiative will ensure that the Canadian medical device regulatory program will meet standards of efficiency and service that industry and the Canadian public have been demanding and that were recommended in the Hearn report and the subsequent review of the report's recommendations.

With respect to the pre-market scrutiny of scientific/technical data, the TPP will undertake an increased workload. The current 5 to 10 percent of medical devices which undergo scientific/ technical scrutiny will increase to 20 percent. For approximately three quarters of these devices (class III), the TPP will review summarized safety and effectiveness information. For the remainder (class IV), a detailed review of data will be required as is currently done.

Since 1995, the TPP has consistently met performance standards acceptable to industry for reviews of applications for the issuance of a Notice of Compliance pursuant to Part V of the current Regulations. The TPP is confident that reviews conducted with this increased workload will continue to be done within acceptable time-frames if adequate resources are available. Performance standards are being developed in consultation with the medical devices industry, will be implemented and performance will be measured against these standards. The TPP is committed to develop and fully meet future performance standards which are internationally competitive with the best in the world, while maintaining its high quality standards.

Alternatives

Cost recovery is Government policy. The activities carried out by the TPP meet the criteria for charging appropriate rates for the services, rights or privileges afforded the medical device industry which directly benefit from these services. Client fees are consistent with the Government's objective of promoting more business-like, consistent and equitable management of the TPP.

The 1994 Program Review resulted in Health Canada being required to find $5.6 million in savings for medical devices regulatory activities. To date, TPP has funded this shortfall through cost recovery for Part V medical device reviews, temporary reallocation of resources from elsewhere in Health Canada, and deferral of lower priority medical device activities; however, with the implementation of the new Regulations, this cannot continue. Failure to raise revenue to replace these Appropriations to pay for the activities required under the new Medical Devices Regulations will make it impossible for the TPP to maintain an adequate regulatory program for medical devices. Canadians expect medical devices to be safe and effective. To maintain a high level of confidence in the safety and effectiveness of medical devices, this cost recovery initiative is considered the only acceptable alternative.

Any acceptable alternative must result in the collection of approximately $7.7 million to support the recommended levels of service and establish efficiencies under the revised proposed Medical Devices Regulations. Stakeholders were invited to propose alternatives to the proposed fee structure, including areas where exemptions or reductions might be appropriate.

The proposed fee schedule reflects consultation with stakeholders over the past six months. This Regulatory Impact Analysis Statement (RIAS) also addresses the concerns expressed by stakeholders during the August consultation workshop and from the analysis of the business impact assessment conducted on this initiative. The majority of these concerns have been addressed through changes to improve the regulatory framework and through improvements to the fee proposal originally presented in August 1997.

The TPP has introduced, or is exploring, a number of options which will cut program costs and introduce new efficiencies. These include, but are not limited to, harmonization of regulatory requirements, the development of mutual recognition agreements with other regulatory authorities, the implementation of quality system requirements whereby audits would be conducted on behalf of the TPP by independent third party audit organizations, and electronic exchange of information between the manufacturers and the TPP. The TPP is also pursuing an approach similar to the TGA in Australia whereby certain lower risk class I products are exempted from any registration or licensing requirements. All of these efforts will enable the TPP to keep the fees at a level which, while providing an appropriate safety assurance to the public, are not economically prohibitive.

Benefits and Costs

This initiative will impact on the following:

Industry

This initiative is expected to directly impact on approximately 1 000 firms producing medical/surgical supplies, diagnostics, implants, hospital equipment and assistive devices. A business impact assessment, equivalent to a Business Impact Test (BIT), was undertaken to assess the impact of a previous fee proposal package. The report entitled Business Impact Assessment of the Proposed Fee Schedule for Medical Devices Sold in Canada was posted on the Web site in early January 1998. The "consultation" section of this RIAS provides a summary of the issues identified and the adjustments made to the fee schedule to reduce the impact on industry. One of the major amendments which resulted from this study was the introduction of the proposed fee reduction provisions.

The funds derived from cost recovery will enable the reform of the medical devices regulatory system recommended in the Hearn report in August 1992 to proceed. Reform to the medical devices regulatory system will enhance the safety and effectiveness of medical devices, as well as public confidence in the regulatory system. An efficient medical devices regulatory process will ensure timely market entry for new medical devices, translating into a significant financial benefit to the industry.

Some benefits to medical device manufacturers, importers and distributors include:

— enhanced confidence amongst Canadians in the safety and effectiveness of medical devices that may well translate into expanded markets;

— reduced costs to industry due to reduced liability;

— international recognition of high and credible Canadian standards, which will provide additional international trade opportunities; and

— assistance and advice from the TPP's scientific professionals.

While the fees will have an impact on industry in terms of increased business costs, the benefit will be an efficient, streamlined and effective medical devices review process. This will result in the medical devices industry having timely access to market which increases overall revenue potential.

Consumers

Canadians must have confidence in the regulatory measures undertaken by the TPP to provide safe and effective medical devices.

A portion of the fees are likely to be passed on by medical devices firms to users in the form of higher prices. The total Canadian wholesale sales of medical devices in 1996 was estimated to have been over $2.6 billion. The $7.7 million which is expected to be recovered therefore represents less than 0.3 percent of Canadian wholesale sales. Furthermore, most devices are not paid for by consumers — there is a fairly small cash market. This market characteristic should further reduce the potential for increased direct consumer costs.

The business impact assessment was conducted to assess anticipated effects of the proposed fees. While the impact of the fees for the examination of applications for medical device licences will not affect firms uniformly, overall the impact of the proposed fees on the price of medical devices is predicted to be acceptable due to the proposed fee reduction provisions which limit the total product fees charged to any firm to a maximum of 1.5 percent.

The collection of fees will ensure that the Canadian public continues to benefit from the availability of safe and effective medical devices assessed in a timely fashion, while paying less through taxes for this program.

Provinces and Health Care Institutions

The major purchasers of medical devices are the provinces and their health care institutions. Thus, they can expect to face the majority of cost increases. However, health care expenditures in Canada in 1996 exceeded $75 billion while sales of medical devices totalled approximately $2.6 billion (about 2 percent of the total health care budget). The ongoing costs associated with this cost recovery initiative are in the order of $7.7 million or less than 0.4 percent of total expenditures on medical devices in Canada. A portion of these increased costs will be passed through to consumers and health care institutions. However, any increase in costs is expected to be small.

At the same time, however, the business impact assessment suggested that without the benefit of fee reduction provisions, two-thirds of devices that remain on the market could experience an average price increase of roughly 5 percent. The extent to which such price increases can be passed on to the health care system is unknown at this time, but this may pose a challenge to health care facilities operating within ever tightening budgets. It has been suggested that facilities will respond by delaying purchases, extending use of existing device technology and reusing devices. While this result might have negative consequences for the quality of health care and the potential risk posed to patients it is not expected to be a widespread occurrence. This aspect will be examined in Phase IV of the TPP cost recovery initiative when real evidence of impact can be collected.

Business decisions may reduce the total number of devices on the market, or the number of suppliers for certain devices, but there will be no impact on availability of high priority devices.

Therapeutic Products Programme

In accordance with the Government's Cost Recovery and Charging Policy, the TPP is expected to recover a portion of its costs through the implementation of client fees for services that provide identifiable recipients with direct benefits beyond those received by the general public. To ensure that the current and planned TPP activities for medical devices are efficient and effective, the TPP determined that approximately $7.7 million must be raised through fees.

The total costs associated with medical device regulatory activities in fiscal year 1998-99 will be in excess of $13 million. The implementation of client fees will enable the TPP to maintain program service standards despite the increased scope of the new Regulations. The cost of building the financial system (e.g. accounts receivable system) to support this initiative was covered at the time of implementation of Phase I of the medical devices cost recovery initiative.

Consultation

Early notice of this regulatory initiative was provided by entry No. HCan/97-13-M of the 1997 Federal Regulatory Plan.

Consultations on client fees began during the deliberations on the Medical Devices Review (Hearn) Committee in 1991-92 and specifically with the publication of Health Protection Branch Information Letters No. 811 and 812.

The report of the Hearn Committee, which was released in August 1992 and which received endorsement of all stakeholders, recommended "the considered development, through appropriate consultations with stakeholders, of a cost recovery system applied selectively to defray, in part, the cost of operating an improved medical devices regulatory programme". Note that this was prior to the Program Review decision which resulted in Health Canada being required to find $5.6 million in savings for medical devices regulatory activities.

The Medical Devices Bureau completed Phase I of its cost recovery initiative by implementing the Medical Devices Fees Regulations on January 1, 1996. In Phase I, client fees were applied to medical devices subject to Part V of the current Medical Devices Regulations.

The proposed Fees to be Paid in Respect of Medical Devices Regulations constitute the second phase of the medical devices cost recovery initiative.

Consultation on fees for activities under the proposed Medical Devices Regulations started with a consultation workshop held by the TPP from August 24 to 26, 1997, with a wide range of industry, provincial government, consumer and health professional stakeholders. Discussions focussed on the acceptability of the proposed fee structure, performance standards, the need for a fee reduction provision and for adequate guidance documents. While industry generally accepted cost recovery and the proposed fee structure in principle, there was concern about the potential impact of fees on company profits of lower sale products on the Canadian market. Preliminary results of the business impact assessment were presented which indicated that the total cost of the TPP, and revenue expected, each represented a lower percentage of total industry sales than similar values for other Health Canada regulatory programs. The proposed fees are proportionally less than fees charged for other regulatory activities at Health Canada. This suggested that the total revenue expected is not unreasonable.

A second consultation workshop was held in October 1997 with a cross section of small businesses to explore mechanisms to mitigate the effect of fees on small business.

On October 15 and 16, 1997, the TPP met with 15 stakeholders representing various sectors of the medical devices industry to further refine the interpretation of a medical device for licensing purposes since this impacts on the application of fees.

Three information sessions were held with the medical devices industry in November and December 1997 to discuss the proposed Medical Devices Regulations published in the Canada Gazette, Part I, on February 15, 1997, and the proposed cost recovery initiative. The TPP met with the Medical Devices Canada (MEDEC) industry association in September 1997 and January 1998 to discuss further the proposed cost recovery initiative.

A business impact assessment, equivalent to a Business Impact Test (BIT), was undertaken to assess the anticipated effect of the proposed fees. The report entitled Business Impact Assessment of the Proposed Fee Schedule for Medical Devices Sold in Canada was posted on the TPP Web site in early January 1998.

Concerns related to the proposed medical devices fees were identified in the comments received following the prepublication of the proposed Medical Devices Regulations in the Canada Gazette, Part I, on February 15, 1997, by the business impact assessment and in comments received from firms and medical device associations following the TPP/industry consultation workshop in August 1997. A summary of the issues identified and the TPP response is provided below:

1. Concern was raised by respondents of the business impact assessment. For small companies with total annual sales of less than $5 million, the proposed client fees were predicted to impose costs representing 7.7 percent or more of total sales. In contrast, for firms with sales in excess of $5 million the client fees will represent less than 1 percent of sales. The proposed client fees were therefore deemed to be inconsequential to larger firms and punitive for smaller businesses.

Response: The business impact assessment did not include any consideration of fee reduction provisions. The TPP is proposing fee reduction provisions to mitigate the effect of fees on small businesses. Three separate fee reduction provisions are proposed. The fee reduction provisions apply to initial product licensing and annual product licensing renewal fees and as an overall cap on the annual product licence renewal fees. The fee reduction provisions will limit the initial product licensing fee to 5 percent of the applicant's actual gross revenue from sales in Canada of the medical device during a two year period beginning on the date that the medical device is first sold in Canada. To reduce the impact on small manufacturers and low sales volume products, a minimum $50 fee for the medical device licence renewal will be charged when the value of the annual wholesale sales of the device is less than $20,000. In addition to the product specific fee reduction provision, there is an overall cap on the annual product licence renewal fees. The cap will limit the overall cost of annual product licence fees to 1.5 percent of total sales of the firm.

The business impact assessment also did not account for changes made to the proposed Medical Devices Regulations to introduce efficiencies to the TPP. For example, the TPP has reduced the requirements for class I medical device manufacturers. Manufacturers of class I medical devices will not be subject to the device licensing requirements under the proposed framework.

Medical devices which are not subject to the product licensing requirements under the proposed framework are exempted from the medical devices licensing fees. These are medical devices which are: custom-made, to be imported or sold under the special access program (emergency use), imported or sold for investigational testing, or class I.

In addition, the medical devices framework brings a number of types of establishments (retailers, health care facilities and manufacturers of class II, III or IV medical devices) outside the scope of the framework, and therefore, exempts these establishments from fees.

2. Stakeholders expressed concern about the high level of fees, specifically for medical device licensing renewal fees for low sales products and fees for the examination of an application for the licensing of an in vitro diagnostic device (IVDD).

Response: The annual medical device licensing fee covers the cost of maintenance activities (primarily post market surveillance activities) for the product licensing performed by the TPP, which in turn are based on risk management principles. The fee reduction provisions mentioned above will mitigate the effect of these fees on low sales devices.

The examination of an application for the licensing of an IVDD fee is based on average costs to conduct an examination of information which must be included in common components of an application for the licensing of an IVDD. A costing analysis of these activities was done by the TPP to establish charges that reflect the costs of services provided.

3. The possibility of increased fees in the future, especially extension to Class I devices, was a concern expressed by stakeholders.

Response: The TPP has modified the requirements for class I medical device manufacturers. Manufacturers of class I medical devices will not be subject to the device licensing requirements under the proposed framework. Manufacturers of class I devices who do not have a licensed Canadian importer or distributor will be required to hold an establishment licence to sell, and will therefore be subject to establishment licensing fees.

4. Respondents of the business impact assessment indicated that they did not understand how to calculate appropriate fees. This appeared to be related to a combination of two key factors: lack of a clear definition of a device for licensing purposes and lack of clarity on risk classification.

Response: On October 15 and 16, 1997, the TPP met with representatives of industry to discuss and clarify the interpretation of a medical device for licensing purposes. The TPP will accept under the same licence application a system, a test kit, a group of devices which can include a procedure pack or tray, an administrative family of devices or a group family consisting of a collection of groups of devices. Guidance documents on the interpretation of a device for licensing purposes and on risk classification were developed in consultation with stakeholders and are available on the TPP Web site.

5. There is concern about the cumulative effect of fees. A number of the respondents of the business impact assessment pay fees to other federal regulatory programs, including: TPP for human drugs; Pest Management Regulatory Agency (PMRA) for pest control products; Bureau of Veterinary Drugs for veterinary drugs. It was suggested at the small businesses workshop that there should be an overall ceiling on the TPP annual client fees.

Response: The TPP's policy Drug/Medical Device Combination Products addresses industry's concerns about drug/ medical device combination products. A review of the fees, including the cumulative effect, will be conducted in Phase IV of the TPP's cost recovery initiative and adjustments will be made accordingly. In the disinfectant area, the TPP is working towards eliminating regulatory overlap with PMRA and duplication of fees was addressed in the Fees to be Paid in Respect of Pest Control Products Regulations.

6. The proposed amount for administrative changes seems significant given the work involved by the Programme in updating its files. As well, the definition of such a change could result in a significant cost to individual companies.

Response: In response to this concern, the fee schedule presented at the August 1997 workshop has been revised. There will be no separate fee for medical device licence amendments which are considered to be administrative amendments. A change in any of the following information is considered to be an administrative amendment:

— the name of the manufacturer;

— the name of the device;

— the medical device identifier; or

— for class II devices, the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

The cost of these activities will be built into the annual product licence renewal fees, thereby reducing administrative costs.

The fee to be paid for an application for a class III or IV medical device licensing amendment will be based on the relevant data components necessary to support the change requested. The manufacturer is required to submit an application for device licensing amendment when proposing to make a change in the information provided for licensing of the device that results in a significant change, or a change that would affect the class of the device. A guidance document on significant changes is being developed and will be available prior to implementation of the proposed Medical Devices Regulations. There will be no fee for application for class II device licence amendments.

7. It has been observed that the current fees for investigational protocols differ for IVDD and non-IVDD devices. Stakeholders stated that the proposed fees will significantly impact their ability to do research and development of new products in Canada.

Response: The regulatory requirements for investigational testing in the proposed new Medical Devices Regulations have been simplified to encourage research and development in Canada. Only the essential data will be assessed by the TPP for authorization to conduct investigational testing. Detailed data will be required as part of the application for device licensing in order for the TPP to assess the safety and effectiveness of the device.

Medical devices imported or sold for investigational testing are not subject to the medical device licensing requirements under the proposed framework. Therefore, there will be no fee for applications for authorization to conduct an investigational testing involving medical devices. Furthermore, some of the fee components of the medical device licensing application will not apply if an authorization for sale of a medical device has been granted to a qualified investigator in the circumstances referred to in Part III of the proposed Medical Devices Regulations.

8. The Programme should demonstrate clear and genuine attempts at introducing cost-efficiencies or alternatives. Industry should not pay for activities that may be less costly using alternative means. The TPP should increase its efforts to cut costs through international harmonization.

Response: The TPP has introduced or is exploring a number of options which will cut Programme costs and introduce new efficiencies. These include, but are not limited to, harmonization of regulatory requirements, the development of mutual recognition agreements with other regulatory authorities, the implementation of quality system requirements whereby audits would be conducted on behalf of the TPP by independent third party audit organizations and electronic exchange of information between the manufacturers and the TPP. The TPP is also pursuing an approach similar to the TGA in Australia whereby certain lower risk class I products are exempted from any registration requirements. All of these efforts will enable the TPP to keep the fees at a level which, while providing safety assurance to the public, are not economically prohibitive and are internationally competitive.

9. The schedule for the finalization and implementation of the Mutual Recognition Agreement was questioned.

Response: After three years of negotiation, Canada and the European Community (EC) have initialled a multi-sectoral recognition agreement (MRA) on conformity assessment. The purpose of the MRA on medical devices is to establish mutual recognition of the ability of each Party to perform conformity assessments to the regulatory requirements of the other Party. The Medical Devices Annex of the MRA covers all devices except in vitro diagnostic devices, silicone gel-filled breast implants, and devices containing drugs. This agreement is subject to the ratification of the political authorities of both Parties and the endorsement of the European Community member states. It is expected that the MRA will come into force in early 1998. The coming into force will include a transition phase (confidence building exercise) and an operational phase.

The confidence building exercise requires European regulatory authorities and conformity assessment bodies (CABs) to demonstrate a requisite level of proficiency in operating to Canadian regulatory requirements. Only those regulatory authorities and CABs demonstrating the required proficiencies will be recognized as able to certify products for the Canadian market. This exercise will include the exchange of information and a series of joint and comparative activities. At the end of this phase, there will be an opportunity to evaluate the results of these activities and, if satisfactory, to move to the operational phase of the sectoral agreement.

Preliminary MRA discussions have been undertaken with Switzerland, New-Zealand, Australia, Japan, and the European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). Additionally, a "partnering" program is underway with the USA's FDA to exchange information and expertise in the pre-market review of medium to high risk medical devices.

10. Stakeholders believe there is a mix of public versus private benefit associated with the work performed by the TPP. The identity of the main beneficiaries of regulatory scrutiny for medical devices needs to be established.

Response: The objectives of the Treasury Board cost recovery policy are increased fairness in the allocation of costs for government programs. The Treasury Board policy assumed 100 percent cost recovery and then allows provisions for a reduced amount. The regulatory activities of the TPP are considered to be services which primarily benefit or are caused by industry. As such, it is appropriate for some or all the associated costs to be recoverable through fees. In this specific case about 65 percent of the total costs of the TPP are being recovered through fees. Appropriations cover the rest including the full cost of some activities considered to be public goods (e.g. special access programme, authorization for investigational testing). This level of cost recovery is consistent with that for drugs, where about 70 percent of funding derives from revenue.

The TPP held an additional consultation workshop from March 25 to 27, 1998, to discuss the proposed Fees to be Paid in Respect of Medical Devices Regulations. More than 40 industry and stakeholder representatives were invited to participate at the workshop. The broad issues discussed included the design of the fee structure, implementation issues, fee reduction and fee exemption provisions and the methodology which was used to determine the unit fees. Participants were receptive to the changes which have been made since the consultation meeting in August 1997 and provided the TPP with other suggestions to improve the regulatory proposal. They expressed support for the principle of fees for medical devices product and establishment licensing, the component based approach of the fee structure and the exemption from fees for:

— class I devices;

— medical devices which are custom-made or imported or sold under the special access program;

— authorizations to conduct investigational testing;

— some of the fee components of the medical device licence application, if an authorization for sale of a medical device has been granted to a qualified investigator in the circumstances referred to in Part III of the proposed Medical Devices Regulations to conduct investigational testing;

— class II device licence amendment; and

— "administrative" device licence amendment.

The greatest remaining concerns center around the degree to which medical device activities will be funded through cost recovery versus appropriation dollars and the impact of costs from both the fees and the new regulatory framework. The TPP will be analysing modifications to the proposed fee reduction provisions and examining the question of equity between Canadian companies and foreign manufacturers. At the close of the meeting participants gave recognition that the TPP is listening to the concerns expressed and working with stakeholders to actively look for solutions.

The consultation process provided an opportunity to discuss methods to make the TPP more efficient and cost-effective, methods of improving the working relationship between the programme and stakeholders, and to discuss the positive aspects of the proposed fee schedule, the issues, potential impacts and the most appropriate means of minimizing negative impacts.

Additional comments received will be collected until the end of the 30-day comment period provided by this prepublication and will be considered in the development of the final proposal to be published in the Canada Gazette, Part II.

Compliance and Enforcement

Compliance mechanisms are provided through the application of the Financial Administration Act, the Food and Drugs Act and Medical Devices Regulations. Compliance mechanisms have been established by the Department of Finance. Outstanding payments will be considered a debt to the Crown and managed according to standard practice.

It is expected that these proposed Regulations will become effective September 1, 1998.

Contact

Nancy Shadeed, at nancy_shadeed@hc-sc.gc.ca, or Julie Gervais, at julie_gervais@hc-sc.gc.ca, Policy Division, Bureau of Policy and Coordination, Therapeutic Products Programme, Health Protection Building, Address Locator 0702B1, Tunney's Pasture, Ottawa, Ontario K1A 0L2, (613) 957-0372 (Telephone), (613) 941-6458 (Facsimile).

PROPOSED REGULATORY TEXT

 

Notice is hereby given that the Governor in Council, pursuant to paragraphs 19(1)(a)(see footnote a) and 19.1(a)(see footnote b) of the Financial Administration Act and, considering that it is in the public interest to remit certain debts, pursuant to subsection 23(2.1)(see footnote c) of that Act, proposes to make the annexed Fees to be Paid in Respect of Medical Devices Regulations.

Interested persons may make representations concerning the proposed Regulations to Julie Gervais, Policy Division, Therapeutic Products Directorate, Department of Health, Address Locator 0702B1, Health Protection Building, Tunney's Pasture, Ottawa, Ontario K1A 0L2, within 30 days after the date of publication of this notice. All such representations should cite the Canada Gazette, Part I, and the date of publication of this notice. The representations should stipulate the parts thereof that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate the parts thereof for which there is no objection to disclosure pursuant to the Access to Information Act.

June 4, 1998

MICHEL GARNEAU
Assistant Clerk of the Privy Council

Definitions	FEES TO BE PAID IN RESPECT OF MEDICAL DEVICES REGULATIONS
	INTERPRETATION
Definitions	1. (1) The definitions in this subsection apply in these Regulations.
"Minister" " ministre "	"Minister" means the Minister of Health.
"Regulations" " Règlement "	"Regulations" means the Medical Devices Regulations, as published in the Canada Gazette, Part I, on February 15, 1997.
Other words and expressions	(2) Unless the context otherwise requires, all other words and expressions used in these Regulations have the meanings assigned to them by the Regulations.
	PART 1
	REGISTRATION FEES
	Application
Applicable classes	2. This Part applies to medical devices that are referred to in the Regulations, other than in the provisions of Part II or III, and that are classified into one of classes II to IV pursuant to sections 5 and 6 of the Regulations.
	Fee to be Paid for the Examination of an Application for Registration of a Class II Medical Device
Class II medical device	3. (1) The fee to be paid by a manufacturer for the examination of an application for registration of a class II medical device is $200.
Time of payment	(2) The fee referred to in subsection (1) is payable at the time the application is submitted.
	Fees to be Paid for the Screening and Examination of an Application for Registration of a Class III or IV Medical Device
Class III or IV medical devices	4. (1) Subject to subsection (2), the fee to be paid by a manufacturer for the screening and examination of an application for registration of a class III or IV medical device is $200 plus the following: (a) in the case of a class III medical device, the sum of the applicable fees set out in column 2 of an item of Schedule 1 for the application information components referred to in column 1 of that item; and (b) in the case of a class IV medical device, the sum of the applicable fees set out in column 2 of an item of Schedule 2 for the application information components referred to in column 1 of that item.
Authorization for sale to a qualified investigator	(2) If an authorization for the sale of a medical device to a qualified investigator has been granted in accordance with subsection 62(2) of the Regulations, the fee to be paid by a manufacturer for the screening and examination of an application referred to in subsection (1) in respect of the medical device is $200 plus the following: (a) in the case of a class III medical device, the sum of the applicable fees set out in column 2 of items 2 to 4 of schedule 1 for the application information components referred to in column 1 of those items; and (b) in the case of a Class IV medical device, the sum of the applicable fees set out in column 2 of items 3 to 12 of Schedule 2 for the application information components referred to in column 1 of those items.
Amendment to device registration	5. The fee to be paid by a manufacturer for the screening and examination of an application for amendment that is a significant change to a medical device in accordance with paragraph 24(a) of the Regulations in respect of a class III or IV medical device or a change that would effect the class of a medical device in accordance with paragraph 24(b) of the Regulations in respect of a medical device that will be classified as a class III or IV medical device, is the following: (a) in the case of a class III medical device, the sum of the applicable fees set out in column 2 of an item of Schedule 1 for the application information components referred to in column 1 of that item that are related to the application for amendment; and (b) in the case of a class IV medical device, the sum of the applicable fees set out in column 2 of an item of Schedule 2 for the application information components referred to in column 1 of that item that are related to the application amendment.
Method of payment — $5,000 or less	6. (1) If the fee payable pursuant to section 4 or 5 or subsection 9(1) is $5,000 or less, the fee is payable at the time the application is submitted.
Screening fee	(2) Despite sections 4 and 5 and subsection 9(1), if an applicant receives a notice from the Minister stating that the application has been screened but has not been accepted for examination, the fee to be paid is (a) 10 per cent of the fee referred to in section 4 or 5, or (b) 10 per cent of the amount referred to in paragraph 9(2)(a).
Method of payment — more than $5,000	(3) If the fee payable pursuant to section 4 or 5 or subsection 9(1) is more than $5,000, the fee is payable as follows: (a) 10 per cent on receipt of a notice from the Minister stating that the application has been screened; (b) 65 per cent on receipt of a notice from the Minister stating that the application has been accepted for examination; and (c) 25 per cent on receipt of a notice from the Minister stating that the application has been approved.
	Reduction
Application for a reduction	7. (1) At the time a manufacturer submits an application for a registration or for an amendment to registration in respect of a medical device, the manufacturer may apply to the Minister for a reduction in the fee payable under subsection 3(1) or section 4 or 5.
Fee reduction granted	(2) The Minister shall grant an application for a reduction where the Minister has reasonable grounds to believe that the fee calculated in accordance with subsection 3(1) or section 4 or 5 will be more than 5 per cent of applicant's actual gross revenue from sales in Canada of the medical device in respect of which the application relates during the following period: (a) in the case of an application for a registration, a two year period beginning on the date that the medical device is first offered for sale in Canada; and (b) in the case of an application for an amendment to registration, a two year period beginning on the date of issuance, by the Minister, of the amended registration.
Fee payable — class II medical devices	8. (1) Where the Minister grants an application for a reduction in respect of a class II medical device application, the fee payable by the manufacturer for the examination of the application for registration of the device is $100.
Actual gross revenue	(2) Where the fee to be paid in accordance with subsection 3(1) is less than 5 per cent of the applicant's actual gross revenue from sales of the medical device in Canada during the period referred to in paragraph 7(2)(a), the fee that is payable is the fee referred to in subsection 3(1).
Time of payment	(3) The fees to be paid in accordance with this section are payable as follows: (a) in the case of the fee referred to in subsection (1), $100 on submission of an application for reduction; and (b) in the case of the fee referred to in subsection (2), an amount equal to the difference between the fee payable under subsection (2) and the fee referred to in paragraph (a), upon expiry of the 60 days following the period referred to in paragraph 7(2)(a).
Audited sales records	(4) If the Minister determines that information available to the Minister is not adequate to calculate the applicant's actual gross revenue from sales of the medical device in Canada during the period referred to in paragraph 7(2)(a), the Minister may require the applicant to submit sales records that have been audited by a qualified independent auditor and those records shall be used for the purpose of determining the fee to be paid.
Fee payable — classes III and IV medical devices	9. (1) Where the Minister grants an application for a reduction in respect of a class III or IV medical device, the fee payable for the screening and examination of an application for registration of that device is the lesser of (a) the fee to be paid in accordance with those sections, and (b) 5 per cent of the applicant's actual gross revenue from sales of the medical device in Canada during the period referred to in paragraph 7(2)(a) or (b) as applicable, as verified by certified sales records prepared in accordance with generally accepted accounting principles provided by the applicant upon expiry of the period referred to in paragraph 7(2)(a) or (b).
Time of payment	(2) The fee calculated in accordance with subsection (1) is payable as follows: (a) an amount equal to 5 per cent of the applicant's anticipated gross revenue from sales of the medical device in Canada during the period referred to in paragraph 7(2)(a) or (b), as applicable, payable by the manufacturer in accordance with subsection 6(1), (2) or (3); and (b) the balance, if any, upon expiry of the 60 days following the period referred to in paragraph 7(2)(a) or (b).
Remission	(3) If upon expiry of the 60 days following the period referred to in paragraph 7(2)(a) or (b) the amount payable in accordance with paragraph 2(a) is greater than the fee referred to on paragraph 1(b), the Minister shall grant a remission to the applicant of an amount equal to the difference between those amounts.
Audited sales records	10. (1) If the Minister determines, on the basis of any information available to the Minister, that the certified sales records provided in accordance with paragraph 9(1)(b) are not adequate to calculate the applicant's gross actual revenue referred to in that paragraph, the Minister may require the applicant to submit sales records that have been audited by a qualified independent auditor.
Discrepancy in sales records	(2) If there is a discrepancy between the applicant's certified sales records referred to in paragraph 9(1)(b) and the audited sales records submitted in accordance with subsection (1), the latter shall be used for the purpose of determining the fee payable.
Failure to submit sales records	(3) If, upon expiry of the 60 days following the period referred to in paragraph 7(2)(a) or (b) an applicant fails to submit to the Minister certified sales records in accordance with paragraph 9(1)(b) or audited sales records in accordance with subsection (1), the fee payable is equal to the difference between the fee referred to in section 4 or 5, and the amount referred to in paragraph 9(2)(a).
	Fee to be Paid for the Right or Privilege to Sell a Medical Device Conferred by Registration
Definition	11. (1) In this section and in section 12 "annual gross revenue" means the gross revenue of the holder of a registration in respect of a medical device, during the holder's previous fiscal year, from sales of the device in Canada.
Amount of fee	(2) The fee to be paid by the holder of a registration, in respect of each medical device registered in the name of the holder, is the following: (a) $100, if the holder's annual gross revenue is $20,000 or more; or (b) $50, if the holder's annual gross revenue is less than $20,000, based on the certified sales records prepared in accordance with generally accepted accounting principles and provided by the holder at the time of payment referred to in subsection (4).
Reduction	(3) Despite subsection (2), if the total amount of fees payable by a person for all medical devices registered in the name of the person is greater than 1.5 per cent of the total annual gross revenue based on certified sales records prepared in accordance with generally accepted accounting principles and provided by the person at the time of payment referred to in subsection (4), the fee that is payable in respect of all medical devices registered in the name of that person is 1.5 per cent of the total annual gross revenue of the person.
Time of payment	(4) The fees referred to in subsections (2) and (3) are payable by the holder of the registration on November 1 of each year in respect of each medical device registered in the holder's name on that date.
Audited sales records	12. (1) If the Minister determines, on the basis of any information available to the Minister, that the certified sales records provided in accordance with paragraph 11(2)(b) or subsection 11(3) are not adequate to calculate the annual gross revenue or total annual gross revenue referred to in those provisions, the Minister may require the applicant to submit sales records that have been audited by a qualified independent auditor.
Discrepancy in sales records	(2) If there is a discrepancy between the applicant's certified sales records referred to in paragraph 11(2)(b) or subsection 11(3) and the audited sales records submitted in accordance with subsection (1), the latter shall be used for the purpose of determining the fee payable.
	PART 2
	ESTABLISHMENT REGISTRATION FEES
	Application
Applicable classes	13. This Part applies to medical devices that are subject to the Regulations, other than the provisions of Part II or III, and that are classified into one of classes I to IV pursuant to sections 5 and 6 of the Regulations.
	Fee to be Paid for the Right or Privilege to Sell a Medical Device Conferred by Granting of Registration to an Establishment
Amount of fee	14. (1) The fee to be paid for the registration of an establishment pursuant to section 28 of the Regulations is the following: (a) $2,530 for each establishment, for initial registration; and (b) $2,120 for each establishment, for the renewal of a registration.
Date of payment	(2) The fee referred to in subsection (1) is payable on the date of issuance of the establishment registration or renewal of the establishment registration, by the Minister.
	PART 3
	TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE
	Transitional Provisions
Definition	15. (1) For the purposes of this section, "old Regulations" means the Medical Devices Regulations, C.R.C., c. 871.
Non- application of the old Regulations	(2) The fee referred to in subsection 3(1), section 4 or subsection 8(1) or 9(1) is payable by a manufacturer if (a) the manufacturer fails to submit the information and documents required in respect of an application for registration referred to in subsection 76(2) of the Regulations before the date referred to in subsection 76(1) of the Regulations; or (b) the medical device is modified in accordance with section 24 of the Regulations; or (c) the notice of compliance or supplementary notice of compliance in respect of the medical device is suspended or cancelled pursuant to section 40 of the old Regulations as if that section were in effect on the date on which these Regulations come into force.
	Coming Into Force
Service fees	16. (1) These Regulations, except for sections 11 to 14, come into force on September 1, 1998.
Registration fees	(2) Sections 11 and 12 come into force on November 1, 1999.
Establishment Registration fees	(3) Sections 13 and 14 come into force on January 1, 2000.

SCHEDULE 1
(Sections 4 and 5)

CLASS III MEDICAL DEVICES

Item	Column 1 Application information component	Column 2 Fee ($)
1.	Description of the medical device and the materials used in its construction and packaging, intended use and a summary of reported problems with the medical device in other countries	140
2.	Summary and conclusions of studies to ensure that the medical device meets the safety and effectiveness requirements of the Regulations	1,470
3.	A copy of the medical device label	170
4.	In the case of a near patient in vitro diagnostic device, a summary of an investigational test conducted on the device using human subjects representative of intended users and under conditions similar to the conditions of use of the device.	440

SCHEDULE 2
(Sections 4 and 5)

CLASS IV MEDICAL DEVICES

Item	Column 1 Application information component	Column 2 Fee ($)
1.	Description of the medical device and the materials used in its construction and packaging, intended use and a summary of reported problems with the medical device in other countries	140
2.	Risk assessment and risk reduction measures in respect of the medical device	1,000
3.	Specifications of the materials used in the construction and packaging of the medical device	680
4.	Production process specifications for the medical device	510
5.	Quality assurance procedures and specifications and quality plan in respect of the medical device	850
6.	In the case of an in vitro diagnostic device, pre-clinical and clinical studies to ensure that the device meets the safety and effectiveness requirements of the Regulations	5,970
7.	In the case of a medical device other than an in vitro diagnostic device, pre-clinical and clinical studies to ensure that the device meets the safety and effectiveness requirements of the Regulations	7,670
8.	Process validation studies to ensure that the Medical device meets the safety and effectiveness requirements of the Regulations	850
9.	Software validation studies to ensure that the medical device meets the safety and effectiveness requirements of the Regulations	2,020
10.	A copy of the medical device label	170
11.	In the case of a medical device, other than an in vitro diagnostic device, manufactured from or incorporating animal or human tissue or their derivative, information substantiating that the device meets the safety and effectiveness requirements of the Regulations	2,620
12.	In the case of a near patient in vitro diagnostic device, detailed information on an investigational test conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use of the device.	2,410

[24-1-o]

Footnote 1

The term "licence" will replace the term "registration" in the new Medical Devices Regulations. Although the proposed Fees Regulations which are published with this Regulatory Impact Analysis Statement (RIAS) employs the terminology used in the proposed Medical Devices Regulations published in the Canada Gazette, Part I, on February 15, 1997, this RIAS refers to the new terminology.

Footnote a

S.C., 1991, c. 24, s. 6

Footnote b

S.C., 1991, c. 24, s. 6

Footnote c

S.C., 1991, c. 24, ss. 7(2)

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