Regulations Amending the Medical Devices Regulations (Updating ISO Standard): SOR/2019-44
Canada Gazette, Part II, Volume 153, Number 4
Registration
SOR/2019-44 February 11, 2019
FOOD AND DRUGS ACT
P.C. 2019-87 February 8, 2019
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 footnote a of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Medical Devices Regulations (Updating ISO Standard).
Regulations Amending the Medical Devices Regulations (Updating ISO Standard)
Amendments
1 The definition of système de gestion de la qualité in section 1 of the French version of the Medical Devices Regulations footnote 1 is amended by replacing “13485:03” with “13485:F16”.
2 The Regulations are amended by replacing “13485:03” with “13485:16” in the following provisions:
- (a) paragraph 32(2)(f);
- (b) paragraph 32(3)(j); and
- (c) paragraph 32(4)(p).
Coming into Force
3 These Regulations come into force on March 1, 2019.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Issues
In 2016, the international standard set by the International Organization for Standardization (ISO), which medical device manufacturers need to follow to demonstrate that they meet Quality Management System certification standards, was updated from the 2003 standard (CAN/CSA-ISO 13485:03) to the 2016 standard (CAN/CSA-ISO 13485:16). Since the Medical Devices Regulations (MDR) make reference to the 2003 standard, an amendment is required to the MDR to update the existing reference to the 2016 standard.
Background
The MDR require medical device manufacturers to submit a Quality Management System (QMS) certificate to Health Canada when applying for a medical device licence. This certificate demonstrates that the QMS under which the device is manufactured and designed satisfies the standard set by the International Organization for Standardization for medical devices (CAN/CSA-ISO 13485:03).
On March 1, 2019, the ISO’s 2016 standard on QMS (CAN/CSA-ISO 13485:16) will formally supersede the 2003 standard (CAN/CSA-ISO 13485:03) and will become the only medical device QMS standard used internationally to demonstrate and support compliance with regulatory requirements related to medical device manufacturing and design. Medical device manufacturers are currently required to submit a QMS certificate to Health Canada when applying for a medical device licence for Class II, III and IV medical devices. footnote 2 The certificate is issued by a third party auditing organization (often referred to as “registrars”) recognized by the Minister under section 32.1 of the MDR footnote 3 and certifies that the QMS, under which the device is manufactured and designed, satisfies CAN/CSA-ISO 13485:03. Amendments to the MDR are being made to require medical device manufacturers, that are subject to the 2003 standard, to follow CAN/CSA-ISO 13485:16 as of March 1, 2019.
The 2016 standard does not introduce any new requirements for Canadian medical device manufacturers. Rather, it updates the 2003 standard by making revisions intended to clarify existing requirements that were vague, confusing or implicit in nature to ensure a common interpretation and application of the ISO standard.
Examples footnote 4 of how the 2016 standard clarifies existing requirements are as follows:
- Refines the requirements of the purchasing process and provides guidance on the content of the quality agreements that need to be in place between suppliers of parts used in medical devices and the manufacturers of medical devices. Device manufacturers need a written agreement from suppliers of parts clarifying the supplier’s responsibility to notify the manufacturer of changes in the purchased product prior to implementing any changes.
- Reinforces the manufacturer’s responsibility to control outsourced processes by emphasizing that the manufacturer remains responsible for any outsourced activities. For example, a medical device manufacturer that outsources a process that can affect a product’s conformity to requirements shall ensure control over such processes.
- Amends the purchasing section to provide clarity around the aspects of suppliers that must be evaluated, and it establishes the need to monitor supplier performance on an ongoing basis. The purchasing section further clarifies the purchasing information to be provided to suppliers as well as providing more clarity on the extent of verification activities required for purchased products.
- Emphasizes that medical device manufacturers must identify their roles within regulatory frameworks, identify the requirements applicable to these roles, and incorporate these requirements into their QMS. For example, manufacturers must use a risk-based approach to determine the processes needed for the QMS and implement those processes; these requirements were previously only implicitly required.
- Limits the application of the term “risk” to the safety and performance of medical devices and compliance with regulatory requirements. This was clarified to make it clear that the CAN/CSA-ISO 13485:16 standard only applies to the medical device sector and its focus is risk management activities related to the regulated aspects of the manufacturer’s activities, and does not include elements such as business risk.
- Clarifies requirements for reporting adverse events and recalls to regulatory authorities. In the previous version of the standard, it was only required that manufacturers communicate with regulators “if required.” The new version clearly states that the manufacturer is responsible with respect to the reporting of adverse events and recalls.
- Clarifies the requirement to differentiate between nonconforming products detected prior to delivery and those detected after delivery. The revised text provides clarity to manufacturers about how to handle nonconforming products that have already been distributed. For example, the evaluation of a nonconforming product must now include, in some cases, an investigation of the external party responsible for the nonconformity.
- Clarifies the requirements for complaint handling. The revised text better aligns with existing regulatory requirements for complaint handling that industry is already adhering to in Canada under the MDR. For example, the medical device manufacturer must document procedures for timely complaint handling in accordance with applicable regulatory requirements. The new CAN/CSA-ISO 13485:16 standard provides the minimum requirements and responsibilities for manufacturers related to complaint handling.
Objectives
The objective of the amendment is to update sections of the MDR that refer to the ISO standard so that the most up-to-date international standard is referenced.
Description
Section 32 of the MDR outlines the licence application requirements for manufacturers of Class II, III and IV medical devices.
The MDR currently require that manufacturers submit a copy of a QMS certificate to Health Canada indicating that the medical devices are manufactured (Class II) or designed and manufactured (Class III and IV) under the ISO standard CAN/CSA-ISO 13485:03. The amendments to the MDR will update the standard referenced in the MDR to the current 2016 standard: CAN/CSA-ISO 13485:16. Three paragraphs of the MDR will be affected by this amendment: paragraphs 32(2)(f), 32(3)(j), and 32(4)(p).
The Regulations also create an amendment to update the reference standard in the definition of “système de gestion de la qualité” that appears in the French version of the MDR only. The definition currently refers to CAN/CSA-ISO 13485:03 and needs to be updated to CAN/CSA-ISO 13485:16.
“One-for-One” Rule
These amendments would not result in a new, or reduced, administrative burden for businesses; therefore, the “One-for-One” Rule does not apply.
There is a minor clarification related to record keeping. While the previous version of the ISO standard implicitly required manufacturers to keep records of their suppliers, the revised standard now makes this requirement more explicit. As a result, in cases where manufacturers may not have been keeping these records, they may incur costs in now beginning to keep these records. Consultations with industry suggest that most, if not all, manufacturers already comply with the new ISO requirements. Therefore, Health Canada does not anticipate that manufacturers will incur new administrative burden costs.
Small business lens
There are approximately 3 700 medical device manufacturers in Canada. This sector is made up of mainly small firms with fewer than 20 workers. The use of the new ISO standard will have a minor cost impact on all manufacturers, including those that would be considered small businesses; however, the proposal has an overall positive impact, as it will ensure that medical devices can continue to be licensed in Canada.
The cost to industry to update to the new ISO standard is estimated to be $15 per manufacturer to update their Standard Operating Procedures (SOPs) to reference the new standard. Given the low-cost and that only a minor update to a reference has to be made, no alternative compliance approaches were considered.
Consultation
The revised standard was developed by the ISO Technical Committee for Quality Management and Corresponding General Aspects for Medical Devices (ISO Technical Committee) and the Canadian Advisory Committee led by the Canadian Standards Association (CSA). These groups included representation from Canadian and international industry (e.g. MEDEC — the national association representing Canada’s medical technology industry — and the Association for the Advancement of Medical Instrumentation) as well as Health Canada officials. The CAN/CSA-ISO 13485:16 standard has been available in Canada for voluntary use since 2016.
During the development of the standard, industry and auditing organizations were given the opportunity to provide input on the revised standard as part of the ISO Technical Committee, and as part of the consultation led by the CSA committee. All comments received through the consultations were sent to the ISO Technical Committee for review and disposition.
In addition, Health Canada notified manufacturers and auditing organizations of these changes in August 2016 through a notice on the Health Canada website and through an email to all licence holders. Health Canada received positive feedback following this announcement concerning the alignment of Health Canada’s transition period with the transition period recommended by the ISO. Health Canada has been requesting that manufacturers include certificates demonstrating compliance to the new 2016 standard when they submit applications or amendments to Health Canada in accordance with the ISO transition guidance, which applies when standards are revised. This procedure has been followed to facilitate the transition to the new 2016 ISO standard. As a result, Health Canada has been receiving the 2016 standard certificates from manufacturers in a progressive manner instead of receiving all of them on March 1, 2019, when the 2003 version of the standard expires.
Rationale
The adoption of the standard, which represents the most up-to-date QMS requirements for the industry, aligns requirements for manufacturers selling medical devices in Canada with the requirements that have been adopted by other countries. Aligning with international partners would ensure that there is no increased regulatory burden for manufacturers selling medical devices in multiple jurisdictions and would maintain the access of Canadians to medical devices. For example, the European Union, Japan and Australia base their quality system requirements on the ISO 13485 standard and are transitioning to the 2016 standard. These jurisdictions require medical device manufacturers to submit a QMS certificate satisfying the ISO standard in order to sell medical devices. The U.S. Quality System Regulation (QSR) is based on the ISO standard although it does not currently formally reference the ISO standard. However, the Commissioner of the U.S. Food & Drug Administration (FDA), in the May 9, 2018, issue of FDA Voices, has proposed to replace certain aspects of the existing QSR with specifications outlined in the most up-to-date ISO 13485 standard by spring 2019.
If the MDR is not amended by March 1, 2019, these Regulations will be out of date and the reference to the 2003 standard will remain in place, which would have a significant impact on both the foreign and the Canadian medical devices industry. If the reference to the 2003 standard remains in place, medical devices in Canada would need to be assessed against the 2003 standard; however, third party auditing organizations would no longer be able to assess medical devices to the 2003 standard as of March 1, 2019, because the 2003 standard will no longer exist internationally.
As a result, Health Canada would not have the authority to issue licences to manufacturers for devices certified to the 2003 standard. The issue affects both the domestic as well as the foreign medical device industry, as foreign manufacturers need to apply for a Canadian medical device licence in order to sell their products in Canada. Both foreign and domestic companies would be unable to sell Class II, III and IV medical devices in Canada without a licence. If that were the case, this would have consequences on the health of Canadians, who would not have access to required medical devices, and on the medical device industry in Canada, which in 2016 was valued at an estimated CDN $8.82 billion.
Health Canada estimates that this amendment will have an overall positive impact on industry. The change in ISO standard would impose a need on manufacturers to rewrite their SOPs to reference the new standard. Health Canada estimates that, in the first year of implementation, approximately 3 700 manufacturers would take an additional 15 minutes at a cost of $60 per hour to update any required SOPs. This figure takes into account manufacturers who may already have updated their SOPs. This would add a cost to the medical devices sector of $55,500 dollars, or $15 per manufacturer. This cost would apply on the first year of implementation only.
Implementation, enforcement, and service standards
Third party auditing organizations are trained on the new standard and will be able to advise manufacturers on how to comply with the 2016 standard.
These amendments will come into force on March 1, 2019.
Contact
Bruno Rodrigue
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca