Singapore legislation

Regulation 11B

of Health Products (Medical Devices) Regulations 2010

Regulation 11B

Exception for wholesale of medical devices to ships or aircraft by licensed importer without wholesaler’s licence

Amended byS 318/2018 wef 01/06/2018

Subregulation 1

A person may supply by wholesale an unregistered medical device to a ship without holding a wholesaler’s licence, if —

(a)

the medical device is imported in accordance with the requirements in regulation 2B(1)(b)(v); and

(b)

the person holds an importer’s licence for the medical device.

Subregulation 2

A person may supply by wholesale an unregistered medical device to an aircraft without holding a wholesaler’s licence, if —

(a)

the medical device is imported in accordance with the requirements in regulation 2B(1)(b)(vi); and

(b)

the person holds an importer’s licence for the medical device.

Subregulation 3

Amended byS 318/2018 wef 01/06/2018

Despite any other provision in these Regulations, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of an unregistered medical device —

(a)

for use on a ship in accordance with paragraph (1); or

(b)

for use on an aircraft in accordance with paragraph (2).