Singapore legislation
Regulation 5B
Regulation 5B
Wholesaling of medical device for use in clinical research
Amended byS 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018
Subregulation 1
Amended byS 318/2018 wef 01/06/2018S 318/2018 wef 01/06/2018
A person may supply by wholesale, without holding a wholesaler’s licence as required under section 14(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)
subject to paragraph (2), where the person is the manufacturer of the medical device, the person gives the Authority notice in accordance with regulation 51 of the supply by wholesale before so supplying the medical device.
Subregulation 2
Amended byS 318/2018 wef 01/06/2018
Paragraph (1)(b) does not apply if the person manufactures the medical device solely by way of secondary assembly.
Subregulation 3
Amended byS 318/2018 wef 01/06/2018
In paragraph (2), “secondary assembly” has the same meaning as in regulation 4(6).