Import of a consignment of registered medical devices

Dealers not authorised by the registrant, who want to import registered medical devices on consignment will require approval from us.

Conditions for using this special access route (SAR)

Under the Health Products Act, the import of registered medical devices must be conducted by licensed dealers authorised by the medical device Registrants. Dealers intending to import a registered medical device but are not authorised by the Registrant to do so are required to apply for approval from us. 

Eligibility

A valid importer's and wholesaler's licence with Good Distribution Practice for Medical Devices (GDPMDS) certification is required.

Documents required

You need to submit the following documents for our review: 

  1. SAR Device List (Downloadable from MEDICS)
  2. Instructions for Use, Product Insert, or Operations Manual by the product owner
  3. Primary medical device label
  4. Attestation34 KB from product owner that the medical device is identical to registered medical device in Singapore, including the manufacturing site, packaging and labelling
  5. SMDR listing number of the original registered medical device
  6. Documentary evidence to show that the medical device is registered in the exporting country e.g. free sale certificate
  7. Certified true copy of ISO 13485 certificate for each of the manufacturing sites
  8. Copy of invoice from exporting company indicating the lot number/serial number of each of the medical device to be imported
  9. Undertaking by importer to take responsibility for quality, safety and performance of the medical device to be imported
  10. 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).