Singapore legislation

Regulation 3A

of Health Products (Medical Devices) Regulations 2010

Regulation 3A

Manufacture of medical device for use in clinical research

Amended byS 334/2016 wef 01/11/2016

A person may manufacture a medical device without holding a manufacturer’s licence under section 12(1) of the Act, if the planned use for the medical device is a clinical purpose in any clinical research.