Indian GMP Requirements For Medical Devices Could Soon Resemble ISO 13485

India’s regulatory body, the Central Drugs Standard Control Organization (CDSCO), recently put forth a proposal to align the country’s good manufacturing practices (GMPs) for medical devices and in vitro diagnostics with the ISO 13485 quality management system standard. Manufacturers compliant with ISO 13485 may now find it easier to register their devices in India. 

ISO 13485:2003 is an international quality standard specifically designed for medical device companies. Using it to guide medical device design, development, and manufacturing is the most common approach for companies that wish to enter the European, Japanese, Australian, and Canadian markets. Design control, process controls, device traceability, and customer feedback are just a few of the key areas that ISO 13485 governs.

Recently, India’s CDSCO drafted a proposal to align its GMP requirements with ISO 13485, according to a recent blog from the Emergo Group. CDSCO is currently soliciting comments on the proposed changes and is accepting comments through December 17, 2014. The proposed changes are focused on quality system requirements and, if enacted, will fall under the country’s Drug and Cosmetic Act.

If the changes are adopted, it may be easier for ISO 13485-compliant companies to enter the Indian market. Because the new standard will closely follow ISO 13485, manufacturers with quality systems that are already in line with the standard will have fewer regulatory hurdles when registering a new medical device in India, according to Emergo.   

While the proposed changes focus on medical devices and in vitro diagnostics, it also addresses the potential for combination devices, according to the newly drafted GMP document. Combination devices are generally thought to be devices that deliver drugs, and they are not easily classified as a drug or a device. On occasions when combination devices are being developed, 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 is currently undergoing extensive revisions, and the updated version is projected to be released sometime in 2015. Generally, standards are revised every few years, which gives the standards committee an opportunity to solicit feedback from manufacturers and incorporate that feedback into an updated version. ISO 13485 has not been updated in over a decade, however, and manufacturers should be prepared to adjust to changes that are certain to arise.