Classification of medical devices

Even as the Medical Devices Rules, 2017  has become effective in the country from January 1, 2018, the Drugs Controller General of India (DCGI) has issued classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017.

The Drug Controller General India (DCGI) is the final authority and controls medical devices and pharmaceuticals. Drug Controller General of India is in charge of endorsement of licenses of particular Drug categories such as IV-Fluids, blood and blood products, Sera, Vaccines and all medical devices. DCGI has notified to all stakeholders – the classification of medical devices and in vitro diagnostic (IVD) medical devices under the provisions of the Medical Devices Rules, 2017, for their regulation with respect to their import, manufacture, clinical investigation, sale, and distribution. However, the safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made there under. Earlier, the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), had notified Medical Devices Rules (MDR), 2017 vide G.S.R. 78 (E) dated 31.01.2017, which are commenced from 01.01.2018.

The said notification is, in exercise of the powers conferred under sub-rule (3) of rule 4 of MDR, 2017 that “The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule.”

Whereas, Rule 2 of MDR, 2017 prescribes the applicability of these rules, in respect of :

  1. Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
  2. Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

The Central Government hereby classifies the medical devices and IVD medical devices, based on the intended use of the device and other parameters specified in the First Schedule.

In this view, the list of medical devices and in vitro diagnostic medical devices notified are subjected to the following parameters:

  1. General intended use given against each of the devices is for guidance to the applicants who intend to furnish application for import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
  2. The components and accessories to a medical device or companion in vitro diagnostic medical de- vices have been classified separately.
  3. It is also recognized that some of the medical devices or in vitro diagnostic medical devices may have dual use and they may be classified accordingly.
  4. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.

Further, the notification lists the medical devices and IVD devices with their risk classes:

  1. List A includes a total of 351 medical Devices in 16 categories with their risk class as per the provisions of Sub- rule (1) of Rule 4 of the MDR, 2017 which prescribes that “Medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:—
    1. Low risk – Class A;
    2. Low moderate risk- Class B;
    3. Moderate high risk- Class C;
    4. High risk- Class D.”
  2. List B includes a total of 247 in vitro diagnostics medical devices in 22 categories with their risk class as per the provisions of Sub-rule (2) of Rule 4 of the MDR, 2017 which prescribes that “In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:—
    1. Low risk – Class A;
    2. Low moderate risk- Class B;
    3. Moderate high risk- Class C;
    4. High risk- Class D.”

In continuation to the earlier Notice vide File No: 29/Misc./3/2017-DC(292) dated 01.11.2017 regarding Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, the Annexure-1 is hereby revised for the following changes: 1. Deletion of S.N. 333 i.e. Sterile Drapes. 2. Revision of risk class of following products:

1. Deletion of S.N. 333 i.e. Sterile Drapes.

2. Revision of risk class of following products:

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The list of medical devices and in vitro diagnostics along with their risk class is also provided as per the provisions of rule 4 of the medical devices rules 2017.

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