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 for 3 years. Certification requires annual surveillance audits to maintain validity.
Official source: QCI ICMED
ICMED certification is increasingly recognised by CDSCO and SLAs, though recognition varies by region and device class. As of 2024, ICMED 13485 is widely accepted for Class C and D licence applications and import approvals. ICMED Basic is accepted for Class A and B manufacturers where Schedule 5 Part I compliance is demonstrated. Manufacturers should verify current acceptance status with their respective licensing authority before relying on ICMED as sole evidence of GMP compliance.