Singapore legislation

Regulation 35A

of Health Products (Medical Devices) Regulations 2010

Regulation 35A

Duty of supplier of unregistered Class A medical devices to furnish information

Amended byS 169/2012 wef 01/05/2012

Where a medical device would have been assigned to Class A according to regulation 24 had it been registered and the medical device is supplied without being registered in accordance with the requirements specified in regulation 10B, the Authority may, under section 41(1) of the Act, by notice in writing, require the supplier of the medical device to furnish to the Authority, within such time as may be specified in the notice, the name, address and licence number of the manufacturer or wholesaler, as the case may be, from whom the supplier obtained the medical device.