Register Class C medical device via full route

Follow this guide to find out the documents, fees and processing time needed to complete the full registration of Class C medical devices.

Eligibility

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 in MEDICS.

Submission requirements

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)

  1. Executive summary
  2. Essential Principles Checklist
  3. Declaration of Conformity
  4. Device description
  5. 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 (if applicable)
    • Shelf-life studies and projected useful life
  6. Clinical Evaluation Report, including publications and full reports of the studies referenced
  7. Device labels
  8. Risk analysis
  9. Name and address of the manufacturing and sterilisation sites
  10. Proof of at least one of the Quality Management Systems below:
    • ISO 13485
    • MDSAP
    • US FDA Quality System Regulations
    • Japan MHLW Ordinance 169
  11. Manufacturing process - flow chart

Additional documents

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.