The European Union and India are moving quickly toward implementing what would be the largest trade agreement either side has ever concluded. Negotiations on the EU-India Free Trade Agreement were completed in January 2026, and in September the European Commission formally submitted the agreement to the Council of the European...
India’s Government Considers a Proposal to Allow Hospitals to Source Med Devices from Manufacturers
The Federal government of India will deliberate and take a decision on whether large hospitals should be allowed to import medical devices directly from the manufacturers. Currently, governmental rules stipulate that an import license is required to procure medical devices from original equipment manufacturers. However, there is no mention in...
India’s Regulations for Safety for Medical Devices
Indian regulations called the Materiovigilance Program of India (MvPI) to institutionalize post-marketing vigilance of medical devices to monitor patient safety throughout the country have been in place for a number of years. Under this program, a manufacturer, importer, distributor, healthcare professional, patient, or other entity can report an adverse event...
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...
India brings Medical Device bill to Parliament
In an amedment to the Drugs and Cosmetisc Act, India seeks to establish the Central Drugs Authority (CDA) to regulate the drugs and cosmetics sector, besides strengthening the infrastructure, manpower, medical device testing labs and training of regulators, S. Eswara Reddy, Deputy Drugs Controller of India, said at a recent...
India Patient Monitoring Market to Grow by $50 million
Increased private sector investments and expansion plans by Apollo Hospitals and Fortis Healthcare are leading to growth of the patient monitoring medical device market in India, according to Medical Design. The market may reach $134 million by the year 2019 according to a study by GBI Research. Medical Device sales...