MAJORITY of the medical devices in India will come under the licensing regime from October 1 as notified by the Central Government, with Union Health Minister Mansukh Mandaviya refusing to relax the deadline for compulsory registration.
According to official sources, the Government has received several representations from manufacturers and their associations seeking extension of the October 1 deadline for registration of Class A-low risk and Class B-low to moderate risk medical devices. In a review meeting, Mandaviya categorically stated 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. As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action, an official source said.
“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,” the source said.
Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the DCA, 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. The Government had issued a notice on July 11 requesting all the manufacturers to apply for obtaining manufacturing licenses to the respective State Licensing Authorities (SLAs) in order to avoid delay in the regulatory process.