#MDR Archives - Value Added

Recent Regulatory Updates from CDSCO for IVD Medical Devices in India

Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.

In a review meeting held last week, Union Health Minister Mansukh 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

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.

IVDs are also Medical Devices and are subject to the same regulatory framework.

In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07