CDSCO seeking input on draft revisions to GMP on medical devices

Schedule M-III of the Indian Drug and Cosmetic Act, describes good manufacturing practices (GMPs) for medical devices. Indian Central Standard Drug Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III. The deadline for the comments on the draft GMPs is 17 December 2014.

The revisions aim at aligning the GMP requirements for medical devices and in-vitro diagnostics with international GMP standards. The aim is to set the quality system for the manufacture of devices and IVDs according to the BIS 15579/ISO 13485 international standard, an internationally recognized quality standard which states the requirements of the quality management system for the design and manufacture of medical devices.

The manufacturing process for the drug/biologics for combination devices should comply to the GMP requirements set out in Schedule M of India’s Drug and Cosmetic Act governing pharmaceutical GMPs however the process of loading the drug/biologics into the device and processes after that will be governed by the proposed device/IVD GMP standards.

View the full Draft Schedule M III Click here