Singapore legislation
Regulation 15
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 15
Records of manufacture
Amended byS 108/2021 wef 01/03/2021
A manufacturer must keep the following records:
(a)
in the case of a manufacturer of clinical research material — records of the manufacture, assembly and testing of the material;
(b)
in the case of a manufacturer of clinical research material that is a CTGT product — records of traceability.