Health Products (Medical Devices) Regulations 2010
Table of Contents
Enacting Formula
Part I PRELIMINARY
1 Citation and commencement
2 Definitions
Part IA MANUFACTURE AND IMPORT OF MEDICAL DEVICES
2A Requirements for issue of manufacturer’s licence
2B Requirements for issue of importer’s licence
Part II MANUFACTURE AND IMPORT OF MEDICAL DEVICES WITHOUT LICENCE
3 Manufacture of medical devices
3A Manufacture of medical device for use in clinical research
3B Manufacture of laboratory-developed tests
3C Manufacture of Class A medical devices for charitable purposes
3D Manufacture of specified dental medical devices
4 Manufacture of medical devices by way of secondary assembly
4A Import of medical devices for personal use
4B Import of medical device licensed under Radiation Protection Act
4C Import of medical device for use in clinical research
Part III SUPPLY OF MEDICAL DEVICES
Division 1 — Wholesale supply
4D Requirements for issue of wholesaler’s licence
5 Wholesaling of self-manufactured medical devices
5A Wholesaling of medical device licensed under Radiation Protection Act
5B Wholesaling of medical device for use in clinical research
Division 2 — Unregistered medical devices
6 Exception for custom-made medical devices, etc.
7 Exception for medical devices which underwent maintenance or repair
8 Exception for medical devices for patients’ use
9 Exception for export or re-export
10 Exception for non-clinical use
10A Exception for clinical research
10B Exception for Class A medical devices
11 Exceptions for phased implementation of prohibition
Division 2A — Other exceptions
11A Exception for import of medical device by licensed manufacturer without importer’s licence
11B Exception for wholesale of medical devices to ships or aircraft by licensed importer without wholesaler’s licence
11C Previously registered medical devices
Division 3 — Requirements for supply
12 Supply of Class A medical devices
13 Supply of "professional use only" medical devices
13A Supply of medical devices for use in clinical research
13B Supply of "trained user only" medical devices
Part IIIA EXCEPTION — EMERGENCY MEDICAL DEVICES
13C Manufacture, import and supply of emergency medical devices
Part IV PRESENTATION OF MEDICAL DEVICES
14 Trade descriptions
15 Information to be provided with medical devices
16 General provisions as to labelling
17 Substantiation of assertions of uniqueness and prominence in presentations
18 Corrective measures in relation to contravening trade descriptions
Part V ADVERTISEMENT OF MEDICAL DEVICES
19 Advertisement of medical device
20 Substantiation of assertions of uniqueness and prominence in advertisements
21 Advertisement of "professional use only" medical devices
22 Restriction on advertisements promoting medical devices for specified diseases and conditions
23 Power of Authority to require copies of advertisements
Part VI REGISTRATION OF MEDICAL DEVICES
24 Assignment of medical devices into classes
25 Requirements for registration
26 Evaluation process
26A Prescribed time for cancellation of registration of medical device for non‑payment of retention fee
27 Disclosure of information on applications for registration
Part VII CERTIFICATES
27 (Deleted)
28 (Deleted)
29 (Deleted)
30 Certification of medical devices intended for export
Part VIII DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF MEDICAL DEVICES
31 Duty of licensees, suppliers and registrants to comply with enforcement orders
32 Duty to comply with conditions of licence or registration
33 Duty of manufacturer
34 Duty of importer
35 Duty of wholesaler
35A Duty of supplier of unregistered Class A medical devices to furnish information
36 Duty of registrant to ensure compliance with safety and performance requirements
36A Duties of sponsor, etc.
37 Offence for contravention of duties
38 Duty to maintain records of manufacture
39 Duty to maintain records of supply
39A Duty to maintain records of receipt and supply in relation to medical devices for clinical research
39B Duty to maintain records of use and disposal, etc., in relation to medical devices for clinical research
40 Qualified practitioners to maintain records of implantable medical devices
41 Duty to maintain records of complaints
42 Reporting of defects and adverse effects
43 Reporting of information adversely affecting quality, safety or efficacy of medical device
44 Notification to Authority concerning recall
45 Duty to furnish report on recall
46 Notification to Authority concerning field safety corrective action
47 Duty to furnish report on field safety corrective action
48 Changes affecting licence
49 Changes concerning registered medical device
Part IX (Deleted)
Part X MISCELLANEOUS
51 Notices to Authority
51A Confidential information
52 Revocation
53 Savings and transitional provision