Regulator Answers Industry's Questions About India’s New Medical Device Rules
A new FAQ document from India's health-care products regulator clarifies requirements relating to manufacturing licenses and other issues under the new medical device rules that came into effect on Jan. 1.
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Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018
The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
Proposals to classify high-end medical devices as drugs are out for comment in India.
The final list of medical devices and IVDs classifies products according to India’s imminent new rules for medtech products. It contains about 100 fewer entries than the original draft issued in June.