Resemblance of Indian GMP Requirements for Medical Devices with ISO 13485
Recently Indian Central Standard Drug Control Organization (CDSCO) has asked for comments on draft revisions to Schedule M-III till 17 December 2014 in order to align the GMP requirements for medical devices and in-vitro diagnostics with international GMP standards and to set the quality system for the manufacture of devices and IVDs (In-vitro diagnostics) according to the ISO 13485, an international standard, quality standard which states the requirements of the quality management system for the design and manufacture of medical devices.
According to the newly drafted GMP document the proposed changes also address the combination devices apart from addressing medical devices and in vitro diagnostics .Combination devices are generally considered as devices that deliver the drug and therefore cannot be easily classified as drug or device. The manufacturing of the drugs in a combination device will be governed by schedule M, while the loading of the drugs into the devices will be governed by the updated GMP document.
ISO 13485:2003 is used as a common guide by the companies for designing, development and manufacturing of medical device for entering into the European, Japanese, Australian, and Canadian markets. Therefore those manufacturers who are already compliant with ISO 13485 will face few regulatory difficulties when registering a new medical device in India.