Print“Closer evaluation of medical devices is called for in recognition of the important role medical devices play in the country.”
Medical device maker targeting the high growth markets of China and India can expect greater scrutiny from regulators there as both countries announced steps they are taking to ensure device are meeting safety and efficacy standards in their countries.
The Drugs Controller General of India ¬says it will soon launch a national inspection effort to identify quality control issues at small and medium medical device manufacturers while also increasing the number of people dedicated to device review, reports PharmaBiz.
The initiative, designed to ensure the safety and efficacy of medical devices in India, is part of a broader expansion of regulatory action in India. In August, India started to recruit an expanded pool of experts to review new drugs, clinical trials, and medical devices. In that context, Drugs Controller General G.N. Singh says that a closer evaluation of medical devices is called for in recognition of the important role medical devices play in the country.
Indian officials are considering a separate set of regulations for medical devices, which are now governed by the nation’s Drugs and Cosmetics Act. That has led the government’s Central Drugs Standard Control Organization to draft new guidance with provisions taking better account of the needs of the medical device industry.
Medical device makers are facing new regulatory attention across the globe. Big companies such as St. Jude Medical and Johnson & Johnson, as well as smaller companies, have encountered increasingly public problems, recalling devices including defibrillators, hip replacements, and breast implants. The potential risks associated with implanted devices in particular have increased concern among some regulators.
China’s State Food and Drug Administration, on a parallel track, says it will soon require foreign device makers to ensure the safety and effectiveness of the medical devices sold and used in China, according to Dezan Shira & Associates, a foreign direct investment specialist that publishes China Briefing. The new SFDA regulations also call for all medical devices sold in China to be labeled in Chinese, while permitting the inclusion of other languages. The regulations take effect April 1, 2013.
October 12, 2012
http://www.burrillreport.com/article-india_and_china_heighten_scrutiny_of_medical_devices.html
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