The Indian law governing the quality and safety of medical devices has been amended and will now apply with effect from 1 April 2020 to all medical devices. Prior to the amendment, only 37 categories of medical devices were regulated or reported to be regulated in the near future in India.
The immediate outcome of the legislative change is as follows:
- All currently unregulated medical devices will have to be approved by the required importers or producers by the Drugs Controller General of India before 1 October 2021. But, medical devices that are either controlled or recommended to be handled are exempted from the registration requirement (see list of 37 types of medical devices in the end of the article that are exempt from enrollment).
- Importers, manufacturers, dealers, distributors and distributors of medical devices currently unregulated in Class A (low-risk) and Class B (low-medium-risk) sold in India are expected to obtain a license prior to 11 August 2022.
- Importers and manufacturers of medical devices currently unregulated in Class C (medium-high risk) and Class D (high risk) sold in India, in addition to traders, distributors and providers, will be required to acquire a permit by 11 August 2023. Medical product importers and producers must be licensed as ISO-134855 compliant so as for certificate for medical products (Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes).
What actually occurred?
The Government of India released two notifications on February 11, 2020: an updated definition of medical devices and the 2020 Medical Devices (Amendment) Regulations. The joint effect of both of these alarms is that, by the date of both alarms, 1 April 2020, all medical devices are going to be set beneath the standard and Safety Regulation. The regulation of the caliber of medical devices by India The high quality and security criteria of import of medical devices are governed by a law known as the Drugs and Cosmetics Act, 1940 ('DCA') in India. The program of the DCA is restricted from time to time to specific medical instruments reported by the authorities as "medication" (commonly known as "advised medical apparatus").
Underneath the DCA, the Medical Devices Regulations, 2017 ('MDR') have been framed. These guidelines set down specific quality requirements that are to be followed by notified marketers/importers/manufacturers/sellers of medical devices.
A compulsory license condition is enforced to guarantee the high quality and security of listed medical apparatus at all levels of the distribution chain throughout the DCA and the MDR. All importers/producers/sellers of advised medical instruments need to receive a license in the proper licensing authority before any transaction in advised medical instruments. It is only after quality checks that a license is issued. The business premises of the license holder are subject to periodic checking. The license holder is also expected to keep accurate records of the sales and transactions made with respect to the notified medical devices and to ensure traceability in the event of a malfunction or complaint related to quality or safety.
New Definition on Medical Devices
37 forms of medical devices have been regulated or identified by the government as drugs until 11 February 2020. The Government exercised its powers on February 11, 2020 to report a new description of medical devices as a medication to one or more forms of medical devices.
As per the notification, medical devices falling under the following description will be regulated under the DCA and MDR as a "drug" effective April 1, 2020:
All products, including tools, apparatus, Appliances, implants, materials or other Items, whether used alone or in combination, Such as Accessories or Software, Especially Meant for Animal or Human use by the manufacturer and used by the manufacturer, by Almost Any pharmacological or immunological or metabolic means, have the primary Planned impact on or in the Animal or Human body, but That Don't Have the Principal effect on the Animal or Human body. action in or on the human body or animals, Treatment or relief of any illness or disorder; (ii) detection, monitoring, treatment, relief or assistance of any accident or disability; (iii) anatomy or physiological process investigation, replacement or alteration or help; (iv) support or preservation of life; (v) disinfection of medical devices; and (vi) supervision of conception.
The new definition referred to above is intended to include all medical devices, according to the technical discussions that followed the notification of the definition referred to above. Therefore, all medical devices sold in India is going to be subject to both DCA and MDR by virtue of the definition out of 1 April 2020, once the definition takes effect.
For the purposes of this Article, 'Newly Notified Medical Devices' shall apply to all medical devices which have not been notified until 11 February 2020 (i.e Apart from the list of 37 types of medical devices referred to at the end of this Article), which will now be protected by the new import of medical devices concept.
The Legislation of the Medical Apparatus (Amendment), 2020
The change into the MDR introduces two alterations into the MDR. The first is that the adoption by their respective producers and importers of a brand new chapter about the enrollment of recently notified medical apparatus. The next is the exception to the supply of enrollment, imposed from the newest chapter, for the 37 kinds of medical apparatus already controlled or advised.
Recently Notified Medical Devices manufacturers or importers will be asked to enroll their medical apparatus together with the Drugs Controller General of India ('DCGI') before October 1, 2021. As of 1 April 2020, the DCGI will begin accepting enrollment software through a dedicated internet portal known as "Online System for Medical Devices" (or by such later date by as soon as the online portal site to prepared to accept software). As of now, there is no time-frame prescribed for the processing of the registration application by DCGI. Registration tends to take place immediately after all the information and documents on the web site have been submitted, That is to say, without any review of the information and documents provided to DCGI by the applicant.