Tighten Up: India and China boost medical device regulations

India and China have both recently introduced new regulation that will impact medical device manufacturers. India’s Department of Pharmaceuticals released a document titled “National Medical Device Policy, 2015” that delineates a new pricing structure for medical devices. China, on the other hand, has briefly lowered barriers to entry on foreign-made medical devices while it ramps up its regulations on domestically produced products. Both actions could relieve common headaches for medical device manufacturers.  

India’s document states that there is a “lack of national regulation” among Indian-made medical devices. The Indian medical device industry faces other issues, such as “training and capacity building… medical device regulators, policy to promote local manufacture… and promoting higher education relevant to medical devices”. As part of the “Make in India 2015” policy, Indian policy makers want to reduce imports on medical devices by setting up stronger regulation for Indian factories, securing both local and international confidence in Indian-made medical devices.

According to the study, the global market for medical devices is over $220 billion. Although India is “one of the top twenty markets for medical devices... and is the 4th largest in Asia”, it holds a relatively small market share because it imports over 65% of its medical devices. Naturally, Indian officials want to increase that market share to boost India’s economy. In order to do so, however, India needs to avoid producing sub-par products that don’t hold up overseas– that means tightening regulations on medical device manufacturing.  

Higher production standards would lead to more domestically produced medical devices, meaning lower costs for those devices in India. Because of the safety standards, which would follow international codes, products could more easily be distributed worldwide. The document states that “within six months” the Department of Pharmaceuticals will bring a detailed proposal to begin boosting the Indian-made medical device sector.

China, too, has faced problems with medical device manufacturing. In the past, scandals have erupted over shoddily-crafted Chinese parts, and some medical device manufacturers have been pulling production from China and reshoring in the United States. In order to slow the reshoring trend, China is attempting to raise standards on its domestic medical device production. Last year, as part of the Made in China 2025 initiative, the country added 40 new regulations to their own medical device industry. In addition, the government revoked licenses of over 1,000 low-grade plastics manufacturers.

China is now having to ease restrictions on foreign pharmaceuticals because of the country’s lack of high-quality devices. In coming months, it may be easier for foreign manufacturers to sell medical devices in China, while the country attempts to consolidate its regulation and work through the many thousands of existing manufacturers that may be producing sub-par devices.

According to Plastics News, these new regulations will be good for the medical plastics sector. Lower-risk products will have fewer requirements, speeding up regulation. In addition, second-tier suppliers  will face tighter regulations, “weeding out some small producers” of sub-par materials. Overall, the provisions for medical devices in China’s Made in China 2025 and India’s Make in India will provide OEMs with more options and clearer regulations when inside their medtech supply chains.


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