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Health Sciences Authority

Free Sale Certificate and Export Certificate

Free Sale Certificate and Export Certificate

Last updated 13 March 2026

Foreign regulatory authorities may require certificates, such as Free Sale Certificates (FSCs) or Export Certificates, to meet import requirements in their jurisdictions. HSA can issue FSCs in a standardised electronic Certificate format based on submission records certifying that the medical devices are permitted for supply in Singapore.

To support your global activities, local medical device dealers can apply for these certificates through SHARE (opens in new tab).

Note:
Kindly ensure your dealer licences and device registration/listing information are valid and information such as "Intended Use", "Manufacturing Site Name and Address", "Model", "Product Number" are accurate.

From 14 July 2025, you may access SHARE with your Corppass for our e-services. Please refer here for more information.

Free Sale Certificate for Medical Devices

Registered medical devices on SMDR
FSCs can be issued to registrant companies that have registered their medical devices on the SMDR.

Class A medical devices on the Class A Database
FSCs can be issued to listing-holder companies that have their Class A medical devices on the Class A Medical Device Database. Please note that Class A medical devices do not require product registration.

Note:
The FSC will only indicate that the Class A device(s) may be supplied in Singapore. Applications will be rejected if the product is not a Class A medical device.

Export Certificate

Export Certificates can be issued to local manufacturers of medical devices that are not registered with HSA.

Note:
For Class A devices, please refer to "Free Sale Certificate for Medical Devices" section above.

How to apply

Submit your Certificate Application through SHARE (opens in new tab).

Fees and turnaround time

Refer to Fees and turnaround time for medical devices for more information.

Amendment to the Free Sale Certificate or Export Certificate after issuance

Once the Certificate is issued, no amendments can be made, and a new application must be made.

The information on the Certificate will be based on Authority's records. If you wish to include additional information it would be subject to HSA's discretion.