Revised: 1 July 2014
The Medicines Act 1981 and its Regulations describe the regulatory scheme for the supply of medical devices in New Zealand. However, some medical devices may be affected by other legislation which must also be complied with before the devices may be legally supplied. Following is a summary of the key Acts and Regulations that may impact on the sale of medical devices. Other Acts and Regulations may also need to be complied with. It is the supplier's responsibility to ensure that its products comply with all applicable legislation.
Medsafe is responsible for administering the Medicines Act 1981 and the Medicines Regulation 1984.
This is the primary Act relating to medical devices. It provides the legal definitions for therapeutic purpose, medical device, and medicine. It also sets requirements for advertising, and establishes penalties for breaches of the Act. The key sections of the Act are:
2 - Interpretation
3A - Meaning of medical device
4 - Meaning of therapeutic purpose
37 - Powers of the Minister to Prohibit Imports etc of Medicines
38 - Restrictions on the Sale of Medical Devices
40 - Compliance with Standards
56-62 (Part 4) - Medical Advertisements
63-87 (Part 5) - Enforcement
97-115 (Part 8) - Miscellaneous Provisions
These Regulations provide detail about how the Medicines Act 1981 is to be applied. The key Regulations are:
4 - Standards for Medicines, Related Products, Medical Devices,
Cosmetics, and Surgical Dressings
7 - Advertisements not to claim Official Approval
10 - Advertisements of Medical Devices
12 - Medicines, Related Products, and Medical Devices not to be sold unless Properly Labelled
17 - Form and Manner of Labelling
18 - Size of Lettering
25 - Misleading Statements
62 - Medical Devices
These Regulations established a notification database to which all sponsors of medical devices in New Zealand must input details of their products. This database is known as the Web Assisted Notification of Devices (WAND) database. The key Regulations are:
3 - Interpretation
5 - Information required to be entered in database
6 - Information and declaration to be supplied by sponsor
7 - Declaration
8 - Updated information to be supplied by sponsor
9 - Sponsor must make arrangements to ensure compliance with regulations 5, 6, and 8
10 - Prohibited statements
11 - Medical device risk classifications in general
12 - Risk classification of particular medical devices
13 - Principles for applying the risk classification rules
14 - Offences
Medsafe is responsible for administering the Medicines (Database of Medical Devices) Regulations 2003.
All electrically powered devices must comply with the requirements of this Act and its associated Regulations before they may be legally supplied in New Zealand.
Energy Safety Services, a business unit of the Ministry of Economic Development, is responsible for administering the Electricity Act 1992.
This Act controls the supply and distribution of contraceptive devices in New Zealand. All contraceptive devices supplied in this country must comply with the requirements of this Act. The key section is;
6 - Standards for the manufacture of condoms
The Ministry of Justice is responsible for administering the Contraception, Sterilisation and Abortion Act 1977, but the Minister of Health has the responsibility for the approval of Standards for contraceptive devices.
Substances that may be hazardous to the environment or to the health of people are controlled under this Act. Devices that are potentially impacted by this Act include in-vitro diagnostic (IVD) devices.
The Environmental Protection Authority (EPA) is responsible for administering the Hazardous Substances and New Organisms Act 1996.
All irradiating apparatus used in New Zealand must comply with the requirements of this Act and its associated Regulations.
The Ministry of Health Office of Radiation Safety is responsible for administering the Radiation Protection Act 1965.
This Act controls the collection, supply, and trade of human tissue and human tissue products in New Zealand.
The Ministry of Health is responsible for administering the Human Tissue Act 2008.
These Regulations control the sale and supply of needles and syringes in New Zealand. These Regulations are made under Section 117 of the Health Act 1956 and Section 37 of the Misuse of Drugs Act 1975.
The Ministry of Health is responsible for administering the Health (Needles and Syringes) Regulations 1998.
Known as the PECPR these Regulations cover the design and inspection of pressure vessels such as autoclaves and bariatric chambers. Associated with these Regulations is an Approved Code of Practice for Pressure Equipment.
The Department of Labour is responsible for administering these Regulations and associated Code of Practice.
Devices using wireless communication must comply with this Act.
Radio Spectrum Management, a business unit of the Ministry of Economic Development, is responsible for administering the Radiocommunications Act 1989.