New Delhi : Pursuant to its ongoing efforts to regulate the medical devices manufactured and imported in the country, the Drugs Controller General (India) has issued a notice classifying 95 medical devices pertaining to dental healthcare under the provisions of 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 to bring in all the medical devices under the regulatory control.
The devices which are classified under the risk Class A include 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, among others.
Devices classified under the risk Class B include polymer dental crown, temporary dental crown/bridge resin, metal/ceramic and polymer dental crown, dental bone particle collector, dental suction system, carboxymethylcellulose sodium denture adhesive, dental amalgam, dental suction system pump, dental suction system disinfection control unit, zinc poly carboxylate dental cement, zinc phosphate dental cement, temporary and permanent preformed dental crown, dental anaesthesia injection kit, among others.
The list also include several devices under the risk Class C such as animal-derived dental bone matrix implant, temporary mandibular condyle prosthesis, transgingival implant, transmandibular implant, bio-absorbable ligated and tacked pliable-polymer dental regeneration membrane, medicate reusable and single-use dental surgical procedure kit, bio absorbable membrane fixation tack, among others.
The notice also elaborates on the general intended use of each of these devices in the notice and said that these are for guidance to the applicants who intend to furnish application of import or manufacture of medical devices under the provisions of the MDR, 2017. However, a device may have 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 the Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk and D has the 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, 1940 and rules and 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 from January 1, 2018.