Certificates

Free Sales Certificate and Export Certificate

Free Sale Certificate for medical devices registered on SMDR

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

A Free Sale Certificate can be submitted online in MEDICS:

  1. Kindly ensure that the information of the registered devices is accurate and there should not be any ongoing Change Notification or open Field Safety Corrective Actions (FSCA) for these devices.

  2. The supporting documents to be attached in the Free Sale Certificate application include:

     

  3. Submit Free Sale Certificate Application using apply@medics 

The processing time for each Free Sales Certificate application is 14 working days.

 

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

This certificate can be issued to companies requiring the certificate for medical devices that are listed on Class A Register. Class A medical devices do not require product registration.

The pre-requisites of obtaining a Free Sales Certificate for Class A medical devices are:

  • The applicant is an ACRA registered company

Application for Free Sale Certificate for Class A medical devices is an offline submission.

  1. Kindly ensure that the information of the Class A medical devices is accurate on the Class A register.
  2. There should not be any ongoing or open Field Safety Corrective Actions (FSCA) for these devices.
  3. The supporting documents required are:
  • IFU and package labels for the importing country
  • Schedule and Appendix in Word format for inclusion in the Certificate
  • Valid QMS (certificates) for the manufacturing site

To apply for the Free Sale Certificate, please email to hsa_md_info@hsa.gov.sg. Please specify the email subject heading as “Application for Free Sale Certificate for Class A Devices". The application form will then be provided for your submission.

Since Class A devices have exception from product registration, the Certificate will only indicate that the Class A device(s) may be supplied in Singapore.

The processing time for each Free Sales Certificate application is 14 working days.

 

Export Certificate

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

The pre-requisites to obtaining an Export Certificate are:

  • An Export Notification for the medical device must first be submitted online (via apply@medics), and
  • The manufacturing site of the product is in Singapore.

An Export Certificate Certificate can be submitted online in MEDICS:

  1. Submit an Export Notification using the apply@medics
  2. Submit an Export Certificate Application using apply@medics
  3. The supporting documents to be attached in the Export Certificate application include:
  • Device labels for the importing country
  • Instructions for Use for the importing country
  • Schedule and Appendix for inclusion in the Certificate
  • Valid QMS certificates, such as ISO 13485 certificate, where the manufacturing site information should correspond with the information in the Export Certificate Applicant

The processing time for Certificate application is 14 working days.

 

Fees for the Free Sale Certificate and Export Certificate

The fee schedule for certificates is available on our website.

 

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 in the Certificate will be according to the information submitted in the Free Sale Certificate or Export Certificate application.

 

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