No extension in deadline for registration of medical devices to manufacturers – Announcement from Union Health Minister
Medical Devices in India will come under the licensing regime from October 1 as notified by the Central Government. Class A and B Device manufacturers, importers have to in compliance with MDR 17 and should have Registration and Licensing in place before Oct 1 2022 to have market access.
Union Health Minister Shri Mansukh Mandaviya has stated in a recent press release that there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe. He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration for seamless process.
As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action after Oct 1 , 2022. The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon.
Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices
All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.