Singapore legislation

Regulation 13

of Health Products (Medical Devices) Regulations 2010

Regulation 13

Supply of “professional use only” medical devices

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 01/06/2018S 318/2018 wef 01/06/2018

For the purposes of section 17(1) of the Act —

(a)

no licensed wholesaler of medical devices shall supply any “professional use only” medical device to any person who intends to supply that medical device to others unless that person is —

(i)

also a licensed wholesaler of medical devices; or

(ii)

a qualified practitioner; and

(b)

no person shall supply, by way of administration or application to any other person, any “professional use only” medical device, unless the person administering or applying the medical device is, or acts under the supervision of, a qualified practitioner.

Subregulation 2

Amended byS 318/2018 wef 01/06/2018

In paragraph (1), “ “professional use only” medical device” means —

(a)

a registered “professional use only” medical device; or

(b)

an unregistered “professional use only” medical device supplied in accordance with regulation 8.