DCGI notifies classification of 48 Medical Devices related to Oncology under MDR, 2017

However, a device may have a specific intended use as specified by its manufacturer, it added.

October 16, 2022

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Last Updated on January 2, 2024 by The Health Master

Download DCGI Notice dt 10-10-2022-Classification of Medical Devices Pertaining to Oncology, the link is given below: As part of its efforts to regulate medical devices in the country, the Drugs Controller General (India) has issued a notice classifying 48 medical devices pertaining to oncology under the provisions of the Medical Devices Rules (MDR), 2017.

Download DCGI Notice dt 10-10-2022-Classification of Medical Devices Pertaining to Oncology, the link is given below

The drug regulator has been classifying the medical devices sold in the country based on the perceived risk of the product type and its use in patients.

The measure is to help the authorities bring in all medical devices under regulatory control.

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The devices which are classified under the risk Class A include:

Antimicrobial post-surgical female underpants,
Antimicrobial post-surgical brassiere,
Brachytherapy radionuclide phantom test object,
Breast binder,
Breast transilluminator,
Reusable cervical cytology scraper,
Ccytotoxic waste receptacle,
Extracorporeal extra vascular-circulation hyperthermia system applicator.

Devices classified under the risk Class B include:

Bladder instillation buffer solution,
Colonic cytology sampling set,
Electronic clinical breast examination system,
Acupressure wristband,
Breast ultrasound imaging system,
Single-use cervical cytology scraper,

Externally-propelled flexible video colonoscope,
Extra vascular-circulation hyperthermia system,
Facial prosthesis,
Flexible fiber optic bronchoscope,
Flexible ultrasound bronchoscope,
Reusable flexible video bronchoscope
Robotic guidance system for image-guided procedures.

Several devices under the risk Class C are listed in the latest classification, among others including:

Ferriscan R2-MRI analysis system,
Alternating electric field antimitotic cancer treatment system generator,
Alternating electric field antimitotic cancer treatment system transducer array,
Breast 3-D infrared imaging/vascular analysis system,
Cryosurgical set,
Capsular tension ring,
Electro cancer therapy system,
Endocervical aspiration,
Balloon kyphoplasty kit.

The list also has a few devices under the risk Class D including:

Alternating electric field antimitotic cancer treatment system,
Ccoronary artery brachytherapy system applicator – manual after loading,

The notice elaborates that the intended use provided in the list is the general intended use of each of these devices and says that these are for guidance to the applicants who intend to furnish an application for the import or manufacture of medical devices under the provisions of the MDR, 2017.

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However, a device may have a specific intended use as specified by its manufacturer, it added.

On October 10, the drug regulator classified a group of 95 medical devices pertaining to dental under the provisions of the MDR, 2017.

The risk associated with Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk, and D has a high risk, according to the widely accepted classification criteria.

The safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, of 1940 and rules for the regulation of medical devices for imports, manufacture, clinical investigation, sale, and distribution.

The Central government has notified the Medical Devices Rules, 2017, which commenced on January 1, 2018.

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