Pursuant to its ongoing efforts to regulate the medical devices manufactured and imported in the country, the Drugs Controller General, India (DCGI) has issued a notice classifying 95 medical devices pertaining to dental healthcare under the provisions of the Medical Devices Rules (MDR), 2017.

The decision comes as the latest in the drug regulator’s efforts to classify 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 authority bring all medical devices under regulatory control.

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

- Dental impression material,
- Dental collar/crown scissors,
- Reusable and single-use dental excavator,
- Reusable and single-use Dappen dish,
- Dental examination kit,

- Reusable and single-use dental spatula,
- Reusable and single-use dental impression material kit,
- Dental polishing brush,
- Dental suction system fluid-separation unit,
- Dental cotton roll.

- Polymer dental crowns,
- Temporary dental crown/bridge resin,
- Metal/ceramic and polymer dental crowns,
- Dental bone particle collector,
- Dental suction system,
- Carboxymethylcellulose sodium denture adhesive,

- Dental amalgam,
- Dental suction system pump,
- Dental suction system disinfection control unit,
- Zinc polycarboxylate dental cement,
- Zinc phosphate dental cement,
- Temporary and permanent performed dental crowns,
- Dental anesthetics.

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- Animal-derived dental bone matrix implants,
- Temporary mandibular condyle prosthesis,
- Bio-absorbable ligated and tacked pliable-polymer dental regeneration membranes,
- Medicated reusable and single-use dental surgical procedure kits,
- Bio-absorbable membrane fixation tacks.

The notice also elaborates on the general intended use of each of these devices in the notice 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.

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

In August, the drug regulator classified a group of 60 medical devices pertaining to rehabilitation 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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