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 The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory approval procedures for medical devices other than in-vitro diagnostic (IVD) medical devices.
The move is in line with the central drug regulator's efforts to ease the regulatory procedures related to medical devices, as part of regulating the medical devices under the Medical Device Rules, 2017.
Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi in a circular, informed, "In order to simplify the regulatory approval procedures and easing the process of risk classification of medical devices other than in-vitro diagnostic (IVD) medical devices, a new risk classification module has been made functional on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in) for all stakeholders w.e.f. November 27, 2025."
"In view of the above, the applicant seeking risk classification for the device which is not listed in the CDSCO published classification list, may submit application through the said portal to obtain risk classification of device under Medical Device Rules, 2017," added the DCGI.
The drug regulator has been developing the digital regulatory system including an Online National Drugs License System (ONDLS) portal as a single window platform for the online processing of various applications submitted by the applicants for issuance of manufacturing and sales licenses, including blood banks and other certificates like COPP, GMP, WHO-GMP, market standing certificate etc., and post-approval changes. The CDSCO also has a separate online platform for procedures related to medical devices regulation.
According to the Rule 4 of Chapter II of the MDR, 2017, the medical devices other than in vitro diagnostic medical devices has been classified on the basis of various parameters mentioned in the Part I of the First Schedule of the Rules, as Class A comprising low risk devices, Class B for low moderate risk devices, Class C for moderate high risk products, and Class D for high risk products. Similar classification has been made for the IVD medical devices, based on Part II of the First Schedule of the Rules.
The Central Licensing 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 of the Rules. The rules also provide powers to the Central Licensing Authority, from time to time, to make additions or deletions in such lists of medical devices or modify the class of any medical device.
The classification helps the regulator to better regulate the sector, by issuing licenses, ensuring regulatory compliance across the categories, and bringing in international standards of regulations.
The government has notified all medical devices to be regulated under the MDR, 2017, in February, 2020 following various discussions on the need to regulate the sector, which has been seeing growth in the recent years.
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