November 22, 2017
India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards, the Central Regulator will regulate all medical devices and IVDs as per their risk classification. A device or IVD with low risk classification will be sparingly regulated. A device or IVD with high risk classification will be strictly regulated.
The revised classification is significantly different from the old classification because it covers only those medical devices that have been already notified as "drug" by the Government of India. The earlier classification covered all medical devices irrespective of whether they were notified by the Government or not. A list of medical devices previously notified by the Government of India can be found at the end of this article, for reference.
At present, the Central Regulator has classified 328 medical devices into various risk classes. With respect to IVDs, the Central Regulator has classified 247 IVDs into various risk classes. All IVDs, excepting IVDs for HIV, Hepatitis B and Hepatitis C, are presently regulated as drugs. The excepted IVDs are presently regulated as notified medical devices. From January 1, 2018, all IVDs will be regulated as medical devices only.
Please note that apart from medical devices and IVDs, the Government has also given a risk classification for surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures and mechanical contraceptives (condoms, intrauterine devices, tubal rings) because from January 1, 2018, these products will be regulated as medical devices under the provisions of the Medical Devices Rules, 2017.
With the publication of revised risk classification in line with provisions of MDR, the Central Regulator has made it clear that it is serious about giving effect to MDR from January 1, 2018. All medical devices companies and IVD companies whose products are currently regulated should review the risk classification of their products since the risk classification has the potential to directly impact the process for applying and obtaining a business license as well as the scope of compliances to be undertaken for marketing of the product in India. Those medical devices companies whose products are not currently regulated should also take note of the risk classification because the Government of India may notify other medical devices in future. Upon such notification, the Central Regulator will classify those medical devices in the same manner as it has classified the presently regulated medical devices.
List of categories of medical devices currently (until December 2017) notified by the Government of India : Ablation Devices, Bone Cements, Cardiac Stents, Catheters, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, I.V. Cannulae, In vitro Diagnostic Devices for HIV, HbsAg and HCV, Internal Prosthetic Replacements, Intra Ocular Lenses, Orthopedic Implants and Scalp Vein Set.