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.
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: email@example.com.
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).