Guidance on medical device compliance and enforcement (GUI-0073): Relevant regulations
On this page
Part 1 – General
- Safety and effectiveness requirements (sections 10 to 20)
- Labelling requirements (sections 21 to 23)
- Contraceptive devices advertising (section 24)
- Stop sale of Class I medical devices (section 25)
- Device licensing requirements (sections 26 to 43)
- Establishment licensing requirements (sections 44 to 51)
- Distribution records requirements (sections 52 to 56)
- Complaint records requirements (section 57)
- Complaint handling procedure requirements (section 58a)
- Recall procedure requirements (section 58b)
- Incident reporting requirements (sections 59 to 61)
- Recall notification requirements (sections 63 to 65)
Part 1.1 – Medical devices for an urgent public health need
- Definitions (section 68.01)
- Advertising authorized Class I medical devices (section 68.031)
- Issuance (section 68.12)
- Amendment (section 68.13)
- Terms and conditions (section 68.19)
- Additional information and material (section 68.23)
- Incident reporting (section 68.27)
- Expanded use (section 68.351)
Part 2 – Custom-made and special access devices
- Authorization requirements (sections 70 to 74)
- Labelling requirements (section 75)
- Distribution records requirements (section 76)
- Incident reporting (section 77)
Part 3 – Devices for investigational testing involving human subjects
- Authorization requirements (sections 80, 82 to 85)
- Record requirements (section 81)
- Labelling requirements (section 86)
- Advertising requirements (section 87)
- Distribution records requirements (section 88)
- Recall procedure requirements (section 88)
- Complaint Handling Requirements (section 88)
- Mandatory Problem Reporting Requirements (section 88)
- Recall Notification Requirements (section 88)
Part 4 – Export certificates
- Export certificate (section 89)
- Signature (section 90)
- Records (section 91)
- Retention time (section 92)
