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.