ICMED Scheme — India QMS Certification
What is ICMED?
ICMED (India Certification for Medical Devices) is an Indian quality management system certification scheme developed by the Quality Council of India (QCI) in collaboration with the Department for Promotion of Industry and Internal Trade (DPIIT) under the Make in India initiative.
ICMED certification validates that a manufacturer's QMS complies with Schedule 5 of the Medical Devices Rules 2017, including ISO 13485:2016 alignment requirements.
ICMED tiers
| Tier | Description |
|---|---|
| ICMED 13485 | Full ISO 13485-aligned certification for Class C and D devices |
| ICMED Basic | Schedule 5 Part I compliance for Class A and B manufacturers |
Who should seek ICMED?
- Indian manufacturers seeking a recognised QMS certificate for CDSCO/SLA licence applications;
- Indian exporters whose foreign markets accept ICMED as equivalent to ISO 13485;
- Manufacturers wishing to demonstrate QMS compliance for PLI scheme applications.
How to certify
- Select an ICMED-accredited certification body from the QCI directory;
- Conduct a gap analysis against Schedule 5;
- Undergo Stage 1 (documentation review) and Stage 2 (on-site audit);
- Receive ICMED certificate (valid 3 years with annual surveillance).
Official source: QCI ICMED