Register Class C medical device via expedited route

Eligibility

Expedited evaluation route 1 (ECR-1)

You are eligible to register your Class C medical device via the expedited evaluation route (ECR-1) if it meets the following criteria:

• 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

• Marketed for at least three years in the above independent reference regulatory agencies' jurisdictions

• No safety issues globally associated with the use of the medical device in the last three years, including:

  • No reported deaths

  • No reported serious deterioration in the state of health of any person

  • No open field safety corrective actions (including recalls) at the point of submission

Expedited evaluation route 2 (ECR-2)

You are eligible to register your Class C medical device via the expedited evaluation route (ECR-2) if it is currently approved by at least two of our independent reference regulatory agencies. These approvals must be on the same medical device labelled use that is intended for the Singapore market.

Note: Approvals from EU and TGA will qualify as independent reference regulatory agency approvals only if devices have been reviewed and approved by the respective agencies and not registered based on the Mutual Recognition Agreement (MRA).

Devices not qualified for ECR

The following Class C devices do not qualify for registration via the Class C expedited evaluation route:

• Hip , knee and shoulder joint replacement non bio-active implants (e.g. non-bioactive metal/polymer implants)

These devices will have to be registered via full or abridged routes only.

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

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

• Letter of Authorisation

• List of configurations of medical devices

• Proof of approval by independent reference regulatory agencies, such as approval letters or certificates:

  • Proof of registration from one independent reference regulatory agency (route ECR-1)

  • Proof of registration from two independent reference regulatory agencies (route ECR-2)

• Proof of marketing history in the same independent reference regulatory agency's jurisdictions (ECR-1 only):

  • Invoice with date

  • Proof of sale

  • Declaration on marketing history

• Declaration of no safety issue globally (ECR-1 only)

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.