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Quality System Overview — Schedule 5 GMP & ISO 13485

Regulatory basis​

All licensed medical device manufacturers in India must maintain a quality management system (QMS) that complies with Schedule 5 of the Medical Devices Rules 2017. Schedule 5 is structured in two parts:

  • Part I — Basic GMP requirements applicable to all device manufacturers (Class A, B, C, D);
  • Part II — Full quality system requirements for higher-risk device manufacturers (Class C and D), largely aligned with ISO 13485:2016.

ISO 13485 and ICMED​

While Schedule 5 Part II aligns with ISO 13485:2016, certification to ISO 13485 alone does not automatically satisfy CDSCO requirements. CDSCO accepts ISO 13485 certificates from accredited certification bodies as evidence of GMP compliance, particularly for import licence applications.

The ICMED (India Certification for Medical Devices) scheme is India's indigenous QMS certification program, administered through QCI (Quality Council of India), designed specifically to certify conformance with Schedule 5 requirements. ICMED certification is increasingly recognised by CDSCO and SLAs as evidence of GMP compliance.

Quality system elements​

See Core GMP Requirements (Schedule 5) for detailed page-by-page coverage of each QMS element.

Inspections​

Manufacturing licences are granted following a successful GMP inspection by CDSCO (for Class C/D) or the State Licensing Authority (for Class A/B). Surveillance inspections occur during the licence period.

Official source: Medical Devices Rules 2017, Schedule 5; ICMED — QCI