3. Manufacture of medical devices
Feedback & supportLast amended by an amending law of 2023. 3 amendments in all.
[Deleted by S 809/2023 wef 18/12/2023]
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 —
is manufactured —
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
in accordance with the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device; and
is intended for the use of a particular patient of the specified healthcare service licensee.
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 —
fitting or adjusting the medical device to meet the requirements of the end user of the medical device; or
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.
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:
[Deleted by S 809/2023 wef 18/12/2023]
a specified healthcare service licensee mentioned in paragraph (1A);
a person mentioned in paragraph (2).
Subregulation 1A
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 —
is manufactured —
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
in accordance with the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device; and
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 —
fitting or adjusting the medical device to meet the requirements of the end user of the medical device; or
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
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:
[Deleted by S 809/2023 wef 18/12/2023]
a specified healthcare service licensee mentioned in paragraph (1A);
a person mentioned in paragraph (2).