Regulation 10B
Exception for Class A medical devices
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 33 of 81
Regulation 10B
Amended byS 318/2018 wef 01/06/2018S 169/2012 wef 01/05/2012S 318/2018 wef 01/06/2018
Subregulation 1
Amended byS 318/2018 wef 01/06/2018
Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of a Class A medical device that is —
(a)
manufactured under a valid manufacturer’s licence or in accordance with regulation 3C;
(b)
imported by the supplier under a valid importer’s licence; or
(c)
obtained by the supplier from a wholesaler who holds a valid wholesaler’s licence.
Subregulation 2
Amended byS 169/2012 wef 01/05/2012S 318/2018 wef 01/06/2018
For the purposes of paragraph (1), a medical device shall be treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered.