SOR-98-282（加拿大医疗器械法规）2024版

这么近那么远

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
  

peggyzt

感谢分享，超级感谢

胖胖鱼

跪谢 太有用了

来自苹果APP客户端

悠悠来

谢谢分享   

雪落此时

非常感谢分享，怎么查询详细的中文内容，我想看召回相关

七君

单独做加拿大出口的，很少见

这么近那么远

七君 发表于 2025-4-3 16:33
单独做加拿大出口的，很少见

为什么呢？市场太小了吗？

kinglion001

感谢分享！学习学习