CANADA: DEVICES FOR INVESTIGATIONAL TESTING The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 95.165. 1. Member to Agreement notifying: CANADA. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Health Canada. 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). Devices for investigational testing 11.020. 5. Title and number of pages of the notified document: Proposed Amendment to the Medical Devices Regulations (pages 1533-1540). 6. Description of content: This amendment to the Medical Devices Regulations will permit the sale of a device under prescribed conditions to a qualified investigator for the purpose of conducting investigational testing. The information gathered will provide further evidence of safety and efficacy of the device for its intended purpose. 7. Objective and rationale: Protection of human health and safety. 8. Relevant documents: Canada Gazette, Part I, 6 May 1995. 9. Proposed date of adoption and entry into force: Not stated. 10. Final date for comments: 20 July 1995. (166)

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