Danvers, MA-based Abiomed announced that the Impella 2.5, Impella CP and Impella 5.0 heart pumps received approval from India's Central Drugs Standard Control Organization for use during high-risk percutaneous coronary intervention, cardiogenic shock, and other reduced left ventricular function conditions. The first patient was treated with the Impella 2.5 heart...
India Simplifies Licensing for Medical Device Manufacturing
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...
India Updates Draft Rules and Fees for Med Devices
After consultations with stakeholders, India's Central Drugs Standard Control Organization (CDSCO), a federal government body, released an updated version of its draft rules for medical devices, including fees payable by the industry. The fees schedule related medical devices is based on 3 categories - A (low risk), B&C (low Moderate...
India Mandates Online Registration for Medical Devices
India’s Central Drugs Standard Control Organization, responsible for overseeing the country’s medical device market, has implemented an online portal for submission of registration certificates and import licenses to facilitate faster commercialization pathways. This online registration applies only to notified medical devices, and from April 1 this registration will be mandatory....
India’s Medtech Sector Sees Healthy Growth
On the recommendation of India’s Drugs Technical Advisory Board, the government has agreed to delink the medical devices sector from the pharmaceutical sector according to a report in The Times of India. India’s Central Drugs Standards Control Organization will post the revised schedule on its Website, and will issue a...