DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

Posted on November 2, 2023 Updated on October 29, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

The Central Drugs Standard Control Organisation (CDSCO) has come out with an updated list of IVDs classified into various risk-based classes, expanding the existing three lists and adding two more lists of IVD medical devices.

The regulator added two lists – Annexure D and E – under which a total of ten more IVD instruments were freshly included. The Annexure D lists five specimen receptacle IVDs including blood collection tube, sample containers, arterial blood gas (ABG) sampler, microcuvette, and other specimen receptacles both vacuum type or otherwise, without needle used for the collection of blood, urine, stool, sputum, semen, etc., for purpose of specimens collection intended for in-vitro diagnostics purpose, all into the risk class A.

Specimen receptacles are the devices, whether vacuum type or not, intended for primary containment and preservation of specimens from the human body. These devices are used for in-vitro diagnostics.

In the Annexure E, added freshly to the IVD list now, has Covid-19 IVDs including Rapid/Elisa/CLIA (serology based) devices, RT-PCR/LAMP (molecular based) devices, antigen test and antigen home tests, all under the risk class C.

Besides, RNA extraction kits and DNA extraction kits intended for specimens derived from human or animal body for in-vitro diagnostics purposes and reagents and kits for detection markers for congenital disorders such as sickle cell, are also included in the Class C.

Viral transport medium (VTM) for specimens derived from human or animal bodies intended for IVD has been listed as Class A.

Meanwhile, the regulator also updated the list of IVD analysers (Annexure A), and IVD instruments (Annexure B), through the new classification list.

While the list released by July 23, 2021 had 53 IVD analyser medical devices, it has now been expanded with 72 products, with devices added in microbiology, toxicology, immunology and other categories.

Similarly, the 2021 list had 19 IVD instruments including specimen processing instrument, it has now been expanded to 29 instruments including tissue embedding system, pipette and micropipette, paraffin flotation bath, paraffin dispenser, microscope glass slide, electrophoresis apparatus, among others.

The list of IVD software devices which are classified under Annexure C remains at eight softwares in the updated list also.

The classification is based on the intended use, risk associated with the device and other parameters specified in the MDR, said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), in his communication.

Safety, quality and performance of medical devices and IVD medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules, made there under. For the regulation of medical devices and IVD devices with respect to the import, manufacture, clinical investigation, clinical performance evaluation, sale and distribution, the Central government has notified MDR, 2017 on January 31, 2017, which has been implemented from January 1, 2018.

The updated list is dynamic and is subject to revision from time to time under the provisions of the MDR, added the regulator.

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