Singapore legislation

Regulation 3

of Health Products (Medical Devices) Regulations 2010

Regulation 3

Manufacture of medical devices

Amended byS 434/2023 wef 26/06/2023S 318/2018 wef 01/06/2018S 950/2022 wef 09/01/2023S 434/2023 wef 26/06/2023

Subregulation 1A

Amended byS 434/2023 wef 26/06/2023

A specified healthcare service licensee may manufacture a medical device without holding a manufacturer’s licence under section 12(1) of the Act if the medical device —

(a)

is manufactured —

(i)

at the approved permanent premises of the specified healthcare service licensee; (ii)at the request of a qualified practitioner who is the specified healthcare service licensee’s personnel; and

(iii)

in accordance with the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device; and

(b)

is intended for the use of a particular patient of the specified healthcare service licensee.

Subregulation 2

A person may manufacture a medical device without holding a manufacturer’s licence under section 12(1) of the Act, if the manufacture is for the purpose of —

(a)

fitting or adjusting the medical device to meet the requirements of the end user of the medical device; or

(b)

enabling the continued use of the medical device by the end user for the purpose for which the medical device was originally provided to the end user.

Subregulation 3

Amended byS 318/2018 wef 01/06/2018S 950/2022 wef 09/01/2023S 434/2023 wef 26/06/2023

The following persons are subject to the duties and obligations of a manufacturer of a medical device under regulations 33(a), 38, 39, 41, 42, 44, 45, 46 and 47:

(a)

[Deleted by S 809/2023 wef 18/12/2023](b)a specified healthcare service licensee mentioned in paragraph (1A);

(c)

a person mentioned in paragraph (2).

Read in full context — Health Products (Medical Devices) Regulations 2010 →