Register Class B medical device via immediate route

Eligibility

You are eligible to register your Class B medical device via the immediate evaluation route if it meets the following criteria:

Condition 1

• Approved by at least one of our independent reference regulatory agencies.
  • These approvals must be on the same medical device labelled use that is intended for the Singapore market.
• Marketed for at least three years in one of the independent reference regulatory agencies' jurisdictions.
• No rejection/withdrawal of the medical device from any of our independent reference regulatory agencies due to quality, performance or safety issues.
• No safety issues globally associated with the use of the medical devicein the last 3 years or since market introduction of the medical devices globally, defined as:
  
  • 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.

Condition 2

• 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.
• No rejection/withdrawal of the medical device from any of our independent reference regulatory agencies due to quality, performance or safety issues.
• 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. 

Standalone medical mobile applications

• It is solely a standalone medical mobile application.
• Approved by at least one of our independent reference regulatory agencies.
  • These approvals must be on the same medical device labelled use that is intended for the Singapore market.
• No rejection/withdrawal of the medical device from any of our independent reference regulatory agencies due to quality, performance or safety issues.
• 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.

Note: If your Class B medical device is approved by both EU and TGA, it will only be considered one approval.

Submission requirements

You need to submit all documents in English.

ASEAN Common Submission Dossier Template (CSDT)

1. Executive summary
2. Device description
3. Summary of preclinical studies
   • Sterilisation validation to be provided for sterile devices only. Software verification and validation studies to be provided for standalone medical mobile applications only.
4. Device labels
5. Name and address of the manufacturing and sterilisation sites
6. 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

• Letter of Authorisation
• List of configurations of medical devices
• Proof of approval by independent reference regulatory agencies (e.g. approval letters, certificates)
• Proof of marketing history in the same independent reference regulatory agency's jurisdictions
  • Invoice with date
  • Proof of sale
  • Declaration on marketing history
• Declaration of no safety issue globally

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.