Skip to main content
A Singapore Government Agency Website How to identify
Official website links end with .gov.sg
Government agencies communicate via .gov.sg websites (e.g. go.gov.sg/open). Trusted websites
Secure websites use HTTPS
Look for a lock () or https:// as an added precaution. Share sensitive information only on official, secure websites.

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

Call the 24/7 ScamShield Helpline at 1799 if you are unsure if something is a scam.

Health Sciences Authority

Register Class B 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 B medical devices.

Last updated 13 March 2026

Eligibility

You are eligible to register your Class B 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. Clinical Evaluation Report (if applicable)

  7. Device labels

  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

Further clinical data may be requested to support additional labelled uses of the device beyond its normal use.

Additional documents

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

You will need the following in order to access SHARE:

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.