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Health Sciences Authority

Import for re-export of unregistered medical devices

Dealers intending to import unregistered medical devices for re-export will require approval from us.

Last updated 13 March 2026

Conditions for using this special access route (SAR)

The supply, including the export, of unregistered medical devices is prohibited under the Health Products Act (HPA). Dealers intending to import medical devices for export without first registering them are thus required to apply for approval from us. Companies with existing importer and wholesaler licences shall not require GN-28 authorisation for import for re-export. However, dealers shall be required to maintain documentary evidence of import and supply (e.g. traceability records) as part of their mandatory device distribution records.

Note: The safety and performance of the device is not assessed by us during application review.

We will consider and allow the import for re-export of an unregistered medical device only on a case by case basis. You can only import the device after your application is approved. 

Import, supply and manufacture of drug of abuse test kits needs additional controlled drug licences under the Misuse of Drugs Act besides licences under Health Products (Medical Devices) Regulations. For more information on controlled drug licence application, please contact the Licensing and Certification Branch at Email: hsa_certification@hsa.gov.sg.

Documents required

You need to submit the following documents for our review: 

  1. SAR Device List (Downloadable from SHARE)

  2. Declaration on Distribution Records (to be submitted within 30 days after date of last export/supply)

Fees and turn-around-time

Refer to medical device fees and turn-around-time for more information.

How to apply

Submit your application through SHARE. Ensure you have the following before you access the e-service:

If you encounter technical issues with SHARE (e.g. unable to upload documents), please e-mail HSA SHARE Support with the screenshot of the error message including the address bar and system time for assistance.