CANADA: MEDICAL DEVICES The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.65 dated 26 Feb. 1997. 1. Member to Agreement notifying: CANADA. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Department of Health. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medical devices. 5. Title, number of pages and language(s) of the notified document: Medical devices. 6. Description of content: The medical devices regulations set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the regulations is to ensure that medical devices distributed in Canada are both safe and effective. The purpose of this amendment is to replace the medical devices regulations which have been in force since 1975, with a new set of medical devices regulations. The new regulations stem from a 1991-1992 review of the department's medical devices program (MDP) which recommended that the MDP should focus on regulating medical devices on a risk assessment and risk management basis. An implementation plan was then developed to act on the recommendations. That plan was founded on two principles: (1) That the level of scrutiny afforded a device should be dependent upon the risk that the device presents; and (2) that the safety and effectiveness of medical devices can best be assessed through a balance of quality systems requirements, pre-market scrutiny and post-market surveillance. In developing these regulations, and consistent with the recommendations from the 1991-1992 review, the MDP conducted extensive examination and evaluation of regulatory systems for medical devices in other jurisdictions (United States, European Union, Japan and Australia). Emphasis was placed on developing requirements which are harmonious with those of our international trading partners and eliminating, to the greatest extent possible, requirements unique to Canada. Adoption of harmonious regulations in Canada will, on the one hand, raise the level of regulatory scrutiny for devices sold in Canada to levels currently exercised in the countries noted above. This will provide greater assurance of the safety and effectiveness of medical devices sold in Canada. On the other hand, harmonization allows meaningful negotiations towards mutual recognition agreements (MRA) to occur, thereby eliminating barriers to trade. MRAS, once operational, will allow devices to be assessed in one jurisdiction and placed on the market in all other jurisdictions party to the agreement without further assessment. The elimination of duplicative assessments also has the effect of significantly reducing compliance costs to both industry and government and quicker access to markets for the industry. It is understood that the benefits of MRAS will be realized in the longer term due to the complexity of the negotiations. The MDP is committed to and supported by industry in achieving this goal and it is this feature of the regulations, more than any other, that is appealing to and supported by the Canadian medical devices industry. 7. Objective and rationale: Protection of human health and safety. 8. Relevant documents: Canada Gazette, Part I, 15 February 1997. 9. Proposed date of adoption: 1 August 1997; Proposed date of entry into force: 1 August 1997. 10. Final date for comments: 30 April 1997. 11. Text available from: National enquiry point. (0099)

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