SOR-98-282（加拿大医疗器械法规）2024版

这么近那么远 · 发表于 2024-11-5 15:21:36

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SOR-98-282（加拿大医疗器械法规）2024
Table of Contents

Medical Devices Regulations
- 1 - Interpretation
- 2 - Application
- 6 - Classification of Medical Devices
- 8 - PART 1 - General
  - 8 - Application
  - 9 - Manufacturer’s Obligations
  - 10 - Safety and Effectiveness Requirements
  - 21 - Labelling Requirements
  - 24 - Contraceptive Devices — Advertising
  - 25 - Class I Medical Devices
  - 26 - Class II, III and IV Medical Devices
    - 26 - Prohibition
    - 28 - Medical Devices Deemed Licensed
    - 32 - Application for a Medical Device Licence
    - 32.1 - Quality Management System Certificate
    - 33 - Foreign Manufacturers
    - 34 - Application for a Medical Device Licence Amendment
    - 35 - Additional Information and Samples
    - 36 - Issuance
    - 37 - Lot of In Vitro Diagnostic Devices
    - 38 - Refusal to Issue
    - 39 - Requests by Minister
    - 40 - Suspension
    - 43 - Obligation to Inform
    - 43.1 - Obligation to Submit Certificate
    - 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing
    - 43.2 - Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision
      - 43.2 - Application
      - 43.3 - Notices to Commissioner of Patents
      - 43.5 - Marking and Labelling
      - 43.6 - Notice to Minister
  - 44 - Establishment Licence
    - 44 - Prohibition
    - 45 - Application
    - 46 - Issuance
    - 46.1 - Annual Review of Licence
    - 47 - Refusal
    - 48 - Notification
    - 49 - Suspension
    - 51.1 - Cancellation
  - 52 - Distribution Records
  - 57 - Complaint Handling
  - 59 - Incident Reporting
  - 61.2 - Serious Risk of Injury to Human Health
  - 61.4 - Summary Report
  - 62 - Provision of Information Under Section 21.8 of Act
  - 62.1 - Assessments Ordered Under Section 21.31 of the Act
  - 62.2 - Activities Ordered Under Section 21.32 of the Act
  - 62.21 - Shortages
  - 63 - Recall
  - 66 - Implant Registration
- 68.01 - PART 1.1 - Medical Devices for an Urgent Public Health Need
  - 68.01 - Definitions and Interpretation
  - 68.02 - Application
  - 68.03 - Authorization
    - 68.03 - Non-application of Part 1 — Importation and Sale
    - 68.031 - Advertising — Authorized Class I Medical Device
    - 68.04 - Deemed Authorization
    - 68.1 - Application for an Authorization
    - 68.12 - Issuance
    - 68.13 - Amendment
    - 68.16 - Refusal
    - 68.19 - Terms and Conditions
    - 68.2 - Applications Submitted Under Part 1
    - 68.21 - Cancellation
    - 68.23 - Additional Information and Material
    - 68.24 - Annual Review
    - 68.241 - Notification — Suspension or Revocation
    - 68.25 - Discontinuance
    - 68.26 - Importation — Copy of Authorization
    - 68.27 - Incident Reporting
    - 68.3 - Serious Risk of Injury to Human Health
    - 68.31 - Summary Report
    - 68.34 - Obligation to Submit Certificate
    - 68.35 - Sale — Cancellation of Authorization
  - 68.351 - Expanded Use
- 69 - PART 2 - Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access
  - 69 - Application
  - 70 - General
  - 71 - Authorization
  - 73 - Additional Information
  - 75 - Labelling
  - 76 - Distribution Records
  - 77 - Incident Reporting
  - 78 - Implant Registration
- 79 - PART 3 - Medical Devices for Investigational Testing Involving Human Subjects
  - 79 - Application
  - 80 - General
  - 81 - Records
  - 82 - Authorization
  - 84 - Additional Information
  - 86 - Labelling
  - 87 - Advertising
  - 88 - Other Requirements
- 89 - PART 4 - Export Certificates
- 93 - PART 5 - Transitional Provisions, Repeal and Coming into Force
  - 93 - Transitional Provisions
  - 96 - Repeal
  - 97 - Coming into Force
- SCHEDULE 1 - Classification Rules for Medical Devices
- SCHEDULE 2 - Implants
- SCHEDULE 3 - Export Certificate for Medical Devices

Related Information

Related Provisions
Amendments Not In Force