In accordance with the two notifications that the Government of India published on 11th February 2020, namely, “A new definition of medical device” and “The Medical Device (Amendment) Rules, 2020 (MDR)”, medical devices are now under the fold of quality and safety regulations, from 1st April 2020.
New definition of medical device
Until 11th February 2020, only 37 categories of medical devices were treated as drugs, however, as per the new notification from the Government of India, the medical devices (Newly Notified Medical Devices) that fall under the following definition are now treated like “drug” and regulated by Drugs Controller General of India (DCGI) and MDR.
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
iii) the investigation, replacement or modification or support of the anatomy or of a physiological process;
iv) supporting or sustaining life;
v) disinfection of medical devices; and
vi) control of conception.”
The Medical Devices (Amendment) Rules, 2020
The new MDR amendment introduces two additions, a new chapter for registration of Newly Notified Medical Devices and an exemption for already regulated 37 categories of medical devices.
Figure 1: The immediate effects of the amendment in the law
Requirements for registration
i) The manufacturers or importers of Newly Notified Medical Devices are required to compulsorily register and obtain a registration number. The applications for registration are commencing from 1st April 2020, through a dedicated online portal called “Online System for Medical Devices” by DCGI.
ii) If an importer or manufacturer fails to obtain registration before 1st October 2021, then it will not be able to market and sell its medical device in India until registration is obtained.
Requirements for obtaining a license
i) In addition to registration, importers and manufacturers of Newly Notified Medical Devices are required to obtain a license under MDR before the prescribed deadline.
Figure 2: Deadlines to obtain a MDR license for import and manufacture
ii) The risk-classification of all medical devices (Class A, B, C, D) will be done by the DCGI, and is expected on or before 1st April 2020.
iii) Also, the supply chain of Newly Notified Medical Devices will have to obtain the appropriate license for distribution or retail sale before the prescribed deadline.
Figure 3: Deadlines to obtain a MDR license for sales and distribution
Relaxation to obtain registration and license
i) For getting acquainted with the transition in the regulatory framework and to obtain ISO 13485 certification, the Government of India has relaxed the requirement to obtain registration and license.
Figure 4: Modified requirements to obtain registration and license
Final insights
i) The new and comprehensive definition of medical devices shall make the homogenized regulation of all medical devices a possible target to achieve. Moreover, the Government has given sufficient time for the pharmaceutical industry to adopt the ISO 13485, and to obtain registration for previously unregulated medical devices.
ii) So far, the industry has reacted positively towards the above initiative. The matter at focus is now the ability of the Central Drugs and Standards Control Organisation (CDSCO) to effectively regulate both drugs and medical devices.
Source: Lexology, The Indian Express, Times of India
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