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.
You need to submit the following documents for our review:
- SAR Device List (Downloadable from MEDICS)
- Instructions for Use, Product Insert, or Operations Manual by the product owner
- Primary medical device label
- Label with a statement to the effect of ‘for supply for non-clinical purpose only’
- 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).