Register Class D medical device via abridged route

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

Eligibility

You are eligible to register your Class D medical device via the abridged evaluation route if it is currently approved by at least one of our independent reference regulatory agencies. This approval must be on the same medical device labelled use that is intended for the Singapore market.

Submission requirements

You need to submit all documents in English.

     ASEAN Common Submission Dossier Template (CSDT)

  1. Executive summary
  2. Essential Principles Checklist
  3. Declaration of Conformity
  4. Device description
  5. Summary of design verification and validation documents:
    • Summary of preclinical studies, including the sterilisation validation and shelf life studies (if applicable)
  6. Summary of Clinical Evaluation Report
  7. Device labels
  8. Risk analysis
  9. Name and address of the manufacturing and sterilisation sites
  10. Proof of at least one Quality Management System below:
    • ISO 13485
    • MDSAP
    • Conformity to 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.