Singapore HSA Updates Medical Device Guidance GN-20: Guidance on Clinical Evaluation

HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, as a benchmark to the industry that clinical investigations are generally expected to be designed, conducted and reported in accordance with ISO 14155, or to a comparable standard, and in compliance with local regulations.

For more details, please refer to updated GN-20 at the following link:

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