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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 [127K] Search: Medical Devices Regulations Go to Advanced Search Table of content   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   Prohibition   Medical Devices Deemed Licensed   Application for a Medical Device Licence   Quality System Certificate   Foreign Manufacturers   Application for a Medical Device Licence Amendment   Additional Information and Samples   Issuance   Lot of In Vitro Diagnostic Devices   Refusal to Issue   Additional Information   Suspension   Obligation to Inform   Obligation to Submit Certificate   Establishment Licence   Prohibition   Application   Issuance   Refusal   Notification   Suspension   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 (Section 6) CLASSIFICATION RULES FOR MEDICAL DEVICES   PART 1 MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC DEVICES   Invasive Devices   Non-invasive Devices   Active Devices   Special Rules   TABLE   PART 2 IN VITRO DIAGNOSTIC DEVICES   Use with respect to Transmissible Agents   Other Uses   Special Rules   TABLE   SCHEDULE 2 (Section 1) IMPLANTS   SCHEDULE 3 (Section 89)   EXPORT CERTIFICATE FOR MEDICAL DEVICES

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