Last Updated on December 31, 2023 by The Health Master
New Delhi: The 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 an extension of the October 1 deadline for registration of Class A-low risk and Class B-low to moderate risk medical devices.
At a review meeting held last week, Mandaviya categorically stated there would 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 (CDSCO) to assist manufacturers who have not yet applied for registration.
As per the rules, unregistered devices will not be deemed authorized and manufacturers may face penal action, an official source said.
“The registration will help in the regulation of medical devices, establishing quality standards, which will help in the 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 Drugs and Cosmetics Act, 1940, for safety, quality, and effectiveness.
A license is presently required to manufacture or import any of 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 issued a notice on July 11 requesting all manufacturers to apply for obtaining manufacturing licenses from the respective State Licensing Authorities (SLAs) in order to avoid delays in the regulatory process.
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