Regulation 3B
Manufacture of laboratory-developed tests
of Health Products (Medical Devices) Regulations 2010
Subsidiary LegislationIn forceProvision 16 of 81
Regulation 3B
Amended byS 1080/2021 wef 03/01/2022S 318/2018 wef 01/06/2018
Subregulation 1
Amended byS 1080/2021 wef 03/01/2022
A person licensed under the Healthcare Services Act 2020 to provide any of the following licensable healthcare services may manufacture a laboratory-developed test without holding a manufacturer’s licence under section 12(1) of the Act, if the person manufactures the laboratory-developed test solely for the provision of that licensable healthcare service:
(a)
a clinical laboratory service;
(b)
a nuclear medicine assay service;
(c)
a blood banking service;
(d)
a cord blood banking service.
Subregulation 2
Amended byS 318/2018 wef 01/06/2018
A person mentioned in paragraph (1) is 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.