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

Follow this guide to find out what is needed to complete the full registration for Class D devices with a registrable drug in a secondary role.

Eligibility

You must register your Class D medical device with a registrable drug in a secondary role via the full evaluation route if it has not previously been approved by any of our independent reference regulatory agencies, and the chemical or biological component has not been evaluated and approved by a competent drug regulatory agency as defined by the World Health Organisation (WHO).

Submission requirements

You need to submit the documents in English.

ASEAN Common Submission Dossier Template (CSDT)

  1. Executive summary
  2. Essential Principles Checklist119 KB
  3. Declaration of Conformity26 KB
  4. Device description
  5. Detailed information of design verification and validation documents:
    • Full reports of preclinical studies e.g. physical test data, biocompatibility studies, animal studies and software verification and validation studies
    • Sterilisation validation (if applicable)
    • Shelf-life studies and projected useful life
  6. Clinical Evaluation Report, including publications and full reports of the studies referenced
  7. Proposed device labelling
  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
    • Conformity to US FDA Quality System Regulations
    • Japan MHLW Ordinance 169
  11. Manufacturing process - flow chart

Additional documents

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:

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.

Share