Per India's Medical Device Rules, 2017 that came into effect in January this year, new licenses awarded for manufacturing and import of medical devices will not need periodical renewal and will remain valid until they are either suspended, cancelled, or surrendered. The licensee will need to pay a retention fee once every...
Regulators Publish New Rules for Medical Devices in India
After exhaustive stakeholder consultations, the Government of India published the new medical device and in vitro diagnostic regulations (IVD) on Jan 31, 2017. The Medical Device Rules, 2017, issued by the Ministry’s Central Drugs Standard Control Organization, will replace India’s longstanding Drugs and Cosmetics Act upon implementation. The new rules...