Health Products (Medical Devices) Regulations 2010
Table of Contents
Enacting Formula
Part I PRELIMINARY
1 Citation and commencement
2 Definitions
Part II MANUFACTURE AND IMPORT OF MEDICAL DEVICES WITHOUT LICENCE
3 Custom-made medical devices
4 Manufacture of medical devices by way of secondary assembly
Part III SUPPLY OF MEDICAL DEVICES
Division 1 — Wholesale supply
5 Wholesaling of self-manufactured medical devices
Division 2 — Unregistered medical devices
6 Exception for custom-made medical devices
7 Exception for refurbished medical devices
8 Exception for medical devices for patients’ use
9 Exception for export or re-export
10 Exception for non-clinical use
11 Exceptions for phased implementation of prohibition
Division 3 — Requirements for supply
12 Testing of registered medical devices before supply
13 Supply of "professional use only" 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 of medical device
26 Abridged evaluation process
Part VII CERTIFICATES
27 Certificates of origin for medical devices
28 Certificates of issue of licences
29 Certificates of registration and certificates of free sale
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 to maintain premises and supply lawfully
36 Duty of registrant to ensure compliance with First Schedule
37 Offence for contravention of duties
38 Duty to maintain records of manufacture
39 Duty to maintain records of supply
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 FEES
50 Applicable fees
Part X MISCELLANEOUS
51 Composition of offences
52 Revocation
53 Savings and transitional provision