Singapore legislation

Regulation 48

of Health Products (Medical Devices) Regulations 2010

Regulation 48

Changes affecting licence

Amended byS 318/2018 wef 01/06/2018S 456/2022 wef 01/07/2022

Subregulation 1

Every licensee shall notify the Authority of —

(a)

any change or proposed change to any particulars furnished by him to the Authority in relation to his application for his licence; and

(b)

any change or proposed change that significantly affects the activities of the licensee that are authorised by his licence.

Subregulation 2

Amended byS 318/2018 wef 01/06/2018S 456/2022 wef 01/07/2022

A notification under paragraph (1) shall —

(a)

be made in such form and manner as the Authority may require;

(b)

be submitted within such time as the Authority may specify in the conditions of the licence;

(c)

be accompanied by such particulars, information, documents and samples as the Authority may require;

(d)

be accompanied by the relevant notification fee specified in the Fees Regulations, if any; and

(e)

if required by the Authority, be accompanied by a statutory declaration by the licensee verifying any information contained in or relating to the notification.

Subregulation 3

A licensee shall not, without the approval of the Authority, make any change that significantly affects the activities of the licensee that are authorised by his licence.

Subregulation 4

An application for the Authority’s approval under paragraph (3) shall be made in such form and manner as the Authority may specify on the Authority’s website.

Subregulation 5

For the purposes of paragraphs (1) and (3), a change that significantly affects the activities of a licensee that are authorised by his licence includes (but is not limited to) a change of one or more of the following:

(a)

the premises where the licensee operates;

(b)

the facilities and equipment used by the licensee;

(c)

the operations and processes carried out by the licensee;

(d)

the personnel responsible for supervising the operations and processes carried out by the licensee.

Subregulation 6

Any licensee 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 7

Any licensee who —

(a)

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

(b)

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.