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.
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: firstname.lastname@example.org.
You need to submit the following documents for our review:
- SAR Device List (Downloadable from MEDICS)
- 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).