You are eligible to register your Class D medical device via the expedited evaluation route (EDR) if it is currently approved by at least two of our independent reference regulatory agencies.
These approvals must be on the same medical device labelled use that is intended for the Singapore market.
Note: Approvals from EU and TGA will qualify as independent reference regulatory agency approvals only if devices have been reviewed and approved by the respective agencies and not registered based on the Mutual Recognition Agreement
Devices not qualified for EDR
The following Class D devices do not qualify for registration via the Class D expedited evaluation route:
- Active implantable devices (e.g. pacemakers, neurostimulators)
- Implantable devices in direct contact with the central circulatory system or central nervous system
- Hip, knee and shoulder joint replacement (e.g. bioactive implants)
- Devices with a registrable drug in a secondary role
- IVD devices intended for:
- HIV testing (screening and diagnosis)
- Blood/tissue donor compatibility testing
These devices will have to be registered via full or abridged routes only.
You need to submit all documents in English.
ASEAN Common Submission Dossier Template (CSDT)
- Executive summary
- Essential Principles Checklist119 KB
- Declaration of Conformity26 KB
- Device description
- Summary of design verification and validation documents:
- Summary of preclinical studies, including the sterilisation validation and shelf life studies (if applicable)
- Summary of Clinical Evaluation Report
- Device labels
- Risk analysis
- Name and address of the manufacturing and sterilisation sites
- Proof of at least one Quality Management System, for example:
- ISO 13485
- Conformity to US FDA Quality System Regulations
- Japan MHLW Ordinance 169
- Manufacturing process - flow chart
Fees and turn-around-time
Refer to medical device fees and turn-around-time for more information.
How to register
You will need to register your medical device through the Medical Device Information Communication System (MEDICS).
You will need the following in order to access MEDICS:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).
Note: You will have to set up a registrant's account in MEDICS in order to complete and submit your product registration application.
Full list of registration guides
If you have a device of another risk class or wish to understand other available registration routes, you may access the full list of registration guides.