100% FDI for Medical Devices Under ‘Automatic Route’ Now

The government has now allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices. “Easing of norms for medical devices industry by creating special carve out in the extant FDI policy on pharma sector will encourage FDI inflows in this area,” said an official statement issued after the Union Cabinet meeting here...

Indian GMP Requirements For Medical Devices Could Soon Resemble ISO 13485

India’s regulatory body, the Central Drugs Standard Control Organization (CDSCO), recently put forth a proposal to align the country’s good manufacturing practices (GMPs) for medical devices and in vitro diagnostics with the ISO 13485 quality management system standard. Manufacturers compliant with ISO 13485 may now find it easier to register their devices in India...

NPPA Issues Notices To Medical Devices

For monitoring of price movement of notified medical devices as drugs under DPCO, 2013, the National Pharmaceutical Pricing Authority has asked the manufacturers and importers of medical devices in the country to urgently produce a slew of documents to examine the extend of price variations of medical devices in the domestic market. The NPPA’s knee-jerk action in this regard comes in the wake of recent media reports that the prices of medical devices regulated as drugs under the Drugs and Cosmetics Act and Rules there under are sold at exorbitant prices with high profit or trade margins, particularly the prices of cardiac stents, drug eluting stents, orthopaedic implants, etc...