Register Class D medical device with a registrable drug in a secondary role via abridged route

Eligibility

You are eligible to register your Class D medical device with a registrable drug in a secondary role via the abridged evaluation route if it is currently approved by at least one of our independent reference regulatory agencies, and the chemical or biological component has been evaluated and approved by a competent drug regulatory agency as defined by the World Health Organisation (WHO). This approval must be on the same medical device labelled use that is intended for the Singapore market.

Submission requirements

You need to submit the 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. Proposed device labelling

8. Risk analysis

9. Manufacturer information

   • Name and address of the manufacturing and sterilisation sites

   • Proof of at least one Quality Management System below:

     • ISO 13485

     • MDSAP

     • Conformity to US FDA Quality System Regulations

     • Japan MHLW Ordinance 169

10. Manufacturing process - flow chart

Additional documents

• Letter of Authorisation

• List of configurations of medical devices

• Proof of approval by one independent reference regulatory agencies (e.g. approval letters, certificates)

• For devices incorporating medicinal products to qualify for abridged route:

  • Proof of approval as a medical device by one independent reference regulatory agency

  • Proof that chemical or biological component has been evaluated and approved by at least one competent drug regulatory agency, as defined by the World Health Organisation (WHO) 

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 Singapore Health Product Access and Regulatory E-System (SHARE).

You will need the following in order to access SHARE:

• CorpPass

If you encounter technical issues with SHARE (e.g. unable to upload documents), please e-mail HSA SHARE Support with the screenshot of the error message including the address bar and system time for assistance.

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.