Free Sale Certificate and Export Certificate
Free Sale Certificate (FSC)
A Free Sale Certificate (FSC) is an official document issued by HSA confirming that a specific medical device is registered in Singapore and is freely sold and marketed in the Singapore market. FSCs are typically required by overseas regulatory authorities as part of a market entry application in another country.
Export Certificate
An Export Certificate is issued by HSA for medical devices that are exported from Singapore. It provides official confirmation of the device's registration status and the manufacturer's details.
When are these certificates needed?
- When a Singapore registrant is applying to register the device in another ASEAN country or other export market;
- When a foreign regulatory authority requires documentary evidence of product approval in the country of origin or export;
- As part of an ASEAN CSDT submission.
How to obtain
FSCs and Export Certificates are applied for through the HSA website and SHARE portal:
hsa.gov.sg/medical-devices/certificates