Certificates of Free Sale and Conformity for Medical Devices in Singapore

1. Overview

The Health Sciences Authority (HSA) issues Certificates of Free Sale (CFS) and Certificates of Conformity (CoC) to facilitate the export of medical devices registered in Singapore. These certificates confirm that the devices are authorised for sale in Singapore and comply with applicable regulatory requirements. Source: https://www.hsa.gov.sg/medical-devices/certificates

2. Certificate of Free Sale (CFS)

A Certificate of Free Sale confirms that the medical device is registered with HSA and is freely sold in Singapore without restrictions. It is commonly required by importing countries to support market access. Source: https://www.hsa.gov.sg/medical-devices/certificates

Eligibility

• The device must hold a valid HSA registration.
• The applicant must be the Singapore registrant or an authorised representative.
• The certificate is issued in the name of the registrant.

Source: https://www.hsa.gov.sg/medical-devices/certificates

3. Certificate of Conformity (CoC)

A Certificate of Conformity attests that the medical device complies with the requirements of the Health Products Act and relevant regulations at the time of registration. It is often requested by overseas authorities as evidence of regulatory compliance. Source: https://www.hsa.gov.sg/medical-devices/certificates

Eligibility

• Similar to CFS: valid HSA registration is required.
• Issued to the registrant or authorised party.

Source: https://www.hsa.gov.sg/medical-devices/certificates

4. Application Process

Applications for both CFS and CoC are submitted through the SHARE portal at https://share.hsa.gov.sg/. Applicants need CorpPass authentication. For technical support, email HSA_SHARE_Support@hsa.gov.sg with screenshots including the address bar and system time. Source: https://www.hsa.gov.sg/medical-devices/certificates

5. Required Documents

• Valid proof of registration (e.g., registration certificate or letter).
• Authorisation letter if applying on behalf of the registrant.
• Any additional supporting documents requested during review.

Source: https://www.hsa.gov.sg/medical-devices/certificates

6. Fees and Turnaround Time

Fees and processing timelines are detailed in the medical device fees section at https://www.hsa.gov.sg/medical-devices/fees. Source: https://www.hsa.gov.sg/medical-devices/certificates

7. Important Notes

• Certificates are issued only for currently registered devices.
• Validity is typically aligned with the registration status.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/certificates