Clinical trial injection bottle and hypodermic needle

GN-20: Guidance on Clinical Evaluation Revision 2

The Health Sciences Authority (HSA) Singapore published minor update of guidance document entitled GN-20 R2 Guidance on Clinical Evaluation on 01 November 2022, stipulating clinical investigations carried out by or on behalf of product owner are encouraged and expected to be designed, conducted, and reported in accordance with international ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects. Otherwise, a comparable standard, in compliance with local regulations could be acceptable.

For full details, refer the revised guideline here.

If you have any queries, please get in touch or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox

Scroll to Top