Singapore legislation
Regulation 4C
Regulation 4C
Import of medical device for use in clinical research
Amended byS 334/2016 wef 01/11/2016S 434/2023 wef 31/12/2021
A person may import, without holding an importer’s licence as required under section 13(1) of the Act, any medical device if —
(a)
the planned use for the medical device is a clinical purpose in any clinical research; and
(b)
the person imports the device —
(i)
after the person has given notice to the Authority of the import in accordance with regulation 51; or
(ii)
in accordance with a permission given by the licensing authority under the Medicines Act 1975 before 1 November 2016 for the import on or after that date.