You must register your medical device via the full evaluation route if it has not previously been approved by any of our
independent reference regulatory agencies
Priority Review Scheme
The Priority Review Scheme provides the option for medical devices companies to gain faster registration and market entry for medical devices. You can opt in to the scheme
You need to submit all documents in English. The submission requirements apply to applicants of the Priority Review Scheme too.
ASEAN Common Submission Dossier Template (CSDT)
The CSDT provides a common template for the submission of medical device information to medical device regulatory authorities of ASEAN member countries. You will need to submit the following CSDT documents as part of the product registration requirements:
- Executive summary.
- Essential Principles Checklist119 KB.
- Declaration of Conformity28 KB.
- Device description.
- Detailed information of design verification and validation documents:
- Full reports of preclinical studies e.g. physical test data, biocompatibility studies, animal studies and software verification and validation studies.
- Metrological requirements.
- Sterilisation validation.
- Shelf-life studies and projected useful life.
- Clinical Evaluation Report, including publications and full reports of the studies referenced.
- Device labels.
- Risk analysis.
- Name and address of the manufacturing and sterilisation sites.
- Proof of at least one of the Quality Management Systems below:
- ISO 13485.
- Conformity to US FDA Quality System Regulations.
- Japan MHLW Ordinance 169.
- Manufacturing process flowchart.
Further clinical data may be requested to support additional labelled uses of the device beyond its normal use.
In addition to the CSDT documents, you will also be required to submit the following:
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.