Certificates

Free Sale Certificate and Export Certificate

Foreign regulatory authorities may require Free Sale Certificates to fulfil import requirements in their jurisdictions. Local medical device dealers may voluntarily apply for Certificates issued by HSA.

Free Sale Certificate for medical devices registered on SMDR

A Free Sale Certificate (FSC) can be issued to registrant companies requiring the certificate for medical devices that are registered on the SMDR.

Documents required:

  • You will need to prepare and submit The Schedule and Appendix I for registered medical devices to be included in the certificate. Kindly ensure that the information is accurate and as registered with HSA in MEDICS and on the SMDR.

How to apply:

 

Free Sale Certificate for Class A medical devices on the Class A Database

A Free Sale Certificate for Class A medical devices can be issued to listing-holder company requiring the certificate for medical devices that are listed on the Class A Medical Device Database. Class A medical devices do not require product registration.

Documents required:

  • You will need to prepare and submit The Schedule and Appendix I for medical devices on the Class A Database to be included in the certificate. Kindly ensure that the information is accurate and as listed on the Class A Database.

How to apply:

  • Submit your Free Sale Certificate Application using this online form.

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

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

Information/Documents required:

  • You will need to prepare and submit The Schedule and Appendix I for unregistered medical devices that are locally manufactured to be included in the certificate.
  • Name and Address of: Product Owner of medical device; Country requiring the certificate

How to apply:

An Export Notification for the unregistered medical devices must first be notified in MEDICS (via apply@medics) before an export certificate application can be made.

An Export Certificate application can be submitted online in MEDICS:

Note:
Kindly ensure your manufacturer's licence is valid and details are accurate. For Class A devices, please refer to "Free Sale Certificate for Class A medical devices on the Class A Database" section above.

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.