Import and supply of unregistered medical devices for non-clinical purpose​s

Dealers who intend to import or manufacture to supply unregistered medical devices for non-clinical purposes will require approval from us.

Conditions for using this special access route (SAR)

The supply of unregistered medical devices is prohibited under the Health Products Act (HPA). Dealers intending to supply medical devices for non-clinical purposes only without first registering them are thus required to apply for approval from us.

Non-clinical use of medical devices refers to any form of use other than on or for humans. These non-clinical purposes include:

  • Training equipment (not for use on humans)
  • Devices for use on animals
  • In vitro diagnostic medical devices for research-use only

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. Instructions for Use, Product Insert, or Operations Manual by the product owner
  3. Primary medical device label
  4. Label with a statement to the effect of ‘for supply for non-clinical purpose only’
  5. 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).

Share