Register Class C medical device via immediate route

Eligibility

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

• 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.

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
   • 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 Medical Device Information Communication System (MEDICS).

You will need the following in order to access MEDICS:

• CRIS company account for MEDICS
• CorpPass or HSA PIN

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.