Singapore legislation
Regulation 10A
Regulation 10A
Exception for clinical research
Subregulation 1
Without prejudice to any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product by a person does not apply to the supply of a medical device if —
the planned use for the medical device is a clinical purpose in any clinical research; and
subject to paragraph (2), where the person is the manufacturer of the medical device, the person gives the Authority notice of the supply in accordance with regulation 51 before supplying the medical device.
Subregulation 2
Paragraph (1)(b) does not apply if the person manufactures the medical device solely by way of secondary assembly.
Subregulation 3
In paragraph (2), “secondary assembly” has the same meaning as in regulation 4(6).