Singapore legislation
Regulation 49
Regulation 49
Changes concerning registered medical device
Subregulation 1
A registrant of a registered medical device must, unless the change is of a type specified on the Authority’s website to be one for which the Authority’s approval is not required, obtain prior approval from the Authority before effecting —
any change or proposed change to any particulars provided in relation to the registration of the medical device; and
any change or proposed change that may affect the safety, quality or efficacy of the medical device.
Subregulation 2
An application for the Authority’s approval under paragraph (1) shall —
be made in such form and manner as the Authority may require;
be submitted within such time as the Authority may specify in the conditions of the registration of the medical device;
be accompanied by such particulars, information, documents and samples as the Authority may require; (d)be accompanied by the relevant fee specified in the Fees Regulations; and
if required by the Authority, be accompanied by a statutory declaration by the registrant verifying any information contained in or relating to the notification.
Subregulation 3
Where any change made to a registered medical device may affect the safety, quality or efficacy of the medical device, the registrant of the medical device shall ensure that the medical device is not supplied until after the Authority has given its approval for the change.
Subregulation 4
[Deleted by S 318/2018 wef 01/06/2018]
Subregulation 5
Any registrant of a registered medical device who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Subregulation 6
Any registrant of a registered medical device who —
in compliance or purported compliance with paragraph (1), furnishes the Authority with any notification under paragraph (1) which he knows is false or misleading; or
contravenes paragraph (3),shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Subregulation 7
For the avoidance of doubt, any reference to a change or proposed change referred to in paragraph (1)(a) does not include any such change by reason only of the registered medical device ceasing to be registrable by virtue of regulation 10B.