3B. Manufacture of laboratory-developed tests
Feedback & supportLast amended by an amending law of 2021. 2 amendments in all.
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 clinical laboratory service;
a nuclear medicine assay service;
a blood banking service;
a cord blood banking service.
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.
Subregulation 1
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 clinical laboratory service;
a nuclear medicine assay service;
a blood banking service;
a cord blood banking service.
Subregulation 2
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.