Regulation 3A
Manufacture of medical device for use in clinical research
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 15 of 81
Regulation 3A
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.