In forceAmendedAs enactedCurrent version · As enactedSee versions on Singapore Statutes Online(opens the publisher’s site)
Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 5 · Duties Relating to Clinical Research Materials
15. Records of manufacture
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Last amended by an amending law of 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.