Agency
All medical devices are regulated by the Medicines and Medical Device Safety Authority (MedSafe)
Medical Device Definition
A medical device means any device instrument, apparatus, appliance or other article-- (i) is intended to be used in, or, or for human beings for a therapeutic purpose; and (ii) does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and (b) includes material that-- (i) is intended to be used in or on human beings for a therapeutic purpose; and (ii) does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and (c) also includes-- (i) anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and (ii) any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of this act; but (d) does not include a device, instrument, apparatus, appliance, article, or material of a kind belonging to a class that is declared by regulations not be a medical device for the purposes of this Act. Medicines Act 1981, Art. 3A
Classification of Medical Device
International Classification |
Description |
Examples |
Risk Level |
Class I |
Simple with history of safe use |
Scalpels, compression bandages, dental kits |
Low |
Class II a |
 relatively low risk to the human body |
Hearing aids, masks for providing anaesthesia, |
Low - Moderate |
Class II b |
Relatively high risk to the human body |
Condoms, blood bags, infusion pumps, |
High - Moderate |
Class III |
Devices that may endanger the
Patient's life |
Cardiovascular stents, joint prostheses, heart valves |
High |