The Health Sciences Authority (HSA) of Singapore has revised guidance documents and templates pertaining to medical device product registrations. The key updates are as follows:
- Apart from requirements of registration under Health Products Act, local supply and use must comply with other legislations such as Private Hospitals and Medical Clinics Act, Healthcare Services Act, Professional Registration Acts (Medical Registration, Dental Registration and others) and Radiation Protection Act.
- Medical Device Single Audit Program (MDSAP) certificate is an addition to the current list of acceptable QMS certificates.
- Fast track evaluation routes such as abridged, immediate and expedited may be utilised only if medical devices have been evaluated and have acquired marketing clearances or approvals from at least one of GHTF founding members.
- For IVD medical device undergoing Full Evaluation Route, clinical evaluation conducted by independent 3rd party e.g., accredited clinical laboratories may be required.
Please refer to the affected guidance documents: GN-15-R9, GN-17 R2 and GN-18 R2 and related templates that can be accessed here.
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