HSA updated medical device product registration guidance documents and related templates

The Health Sciences Authority of Singapore (HSA) recently revised the guidance documents and templates related to the registration of medical device products. The main updates are as follows:

1. In addition to the registration requirements stipulated in the Health Products Act, local supply and use must comply with other legislation, such as the Private Hospitals and Clinics Act, the Medical Services Act, the Professional Registration Act (medical registration, dental registration, etc. ) and the Radiation Protection Act.

2. The Medical Device Single Audit Program (MDSAP) certificate is in addition to the current list of acceptable QMS certificates.

3. Expedited evaluation routes, such as shortened, immediate and expedited evaluation routes, can only be used if the medical device has been evaluated and received marketing authorization or approval from at least one GHTF founding member.

4. For in vitro diagnostic medical devices undergoing comprehensive evaluation, clinical evaluation by an independent third party, such as an accredited clinical laboratory, may be required.

Please see affected guidance documents: GN-15-R9, GN-17 R2, and GN-18 R2;