Schedule 5 Gmp

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 5 of the Medical Devices Rules 2017 specifies Good Manufacturing Practice (GMP) standards for medical device manufacturers. Key requirements include: documented quality management systems, personnel training and competency, manufacturing facility design and maintenance, process controls and validation, equipment qualification, materials management, in-process and finished product testing, documentation and record-keeping, and corrective/preventive action procedures. GMP compliance is mandatory for all medical device manufacturers operating in India. Compliance is verified during facility inspections conducted by CDSCO, and manufacturers must maintain documentation demonstrating ongoing adherence to GMP standards throughout the device lifecycle. Non-compliance may result in warning letters, product recalls, or suspension of manufacturing licenses.