Import for re-export of unregistered medical devices

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

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.

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

Documents required

You need to submit the following documents for our review: 

  1. SAR Device List (Downloadable from MEDICS)
  2. Declaration on Distribution Records

 

Fees and turn-around-time

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

How to apply

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

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

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