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Consolidated Statutes and Regulations Enabling Statute: Food and Drugs Act Medical Devices Regulations (SOR/98-282) Disclaimer: These documents are not the official versions (more). Full Document for Printing [202K] Regulation current to September 15, 2006 Search: Medical Devices Regulations Go to Advanced Search Table of contents (Details)   MEDICAL DEVICES REGULATIONS   INTERPRETATION   APPLICATION   CLASSIFICATION OF MEDICAL DEVICES   PART 1: GENERAL   Application   Manufacturer’s Obligations   Safety and Effectiveness Requirements   Labelling Requirements   Contraceptive Devices — Advertising   Class I Medical Devices   Class II, III and IV Medical Devices   Establishment Licence   Distribution Records   Complaint Handling   Mandatory Problem Reporting   Recall   Implant Registration   PART 2: CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL ACCESS   Application   General   Authorization   Additional Information   Labelling   Distribution Records   Reporting an Incident   Implant Registration   PART 3: MEDICAL DEVICES FOR INVESTIGATIONAL TESTING INVOLVING HUMAN SUBJECTS   Application   General   Records   Authorization   Additional Information   Labelling   Advertising   Other Requirements   PART 4: EXPORT CERTIFICATES   PART 5: TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE   Transitional Provisions   Repeal   Coming into Force   SCHEDULE 1: CLASSIFICATION RULES FOR MEDICAL DEVICES   PART 1: MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC DEVICES   PART 2: IN VITRO DIAGNOSTIC DEVICES   SCHEDULE 2: IMPLANTS   SCHEDULE 3: EXPORT CERTIFICATE FOR MEDICAL DEVICES

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