MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)
NOTIFICATION, New Delhi, the 11th February, 2020
Ministry of Health and Family Welfare (MoHFW) has brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulating them under the Drugs and Cosmetics Act (DCA). A gazetted notification to this effect has been issued on 11.02.2020 and the notification will come into effect from April 1.The move implies that any product used to treat a patient will come under the ambit of the DCA. Thus government will now have oversight on the medical devices industry and its activities in the country.A list of 37 devices has been drawn up and it includes syringes, needles, stents, catheters, intraocular lenses, intravenous cannulae, prosthetic replacements, ligatures, sutures, staplers, condoms, blood bags, nebulizers, blood pressure monitoring machines and digital thermometers. At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control. Medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). Such registration is voluntary for a period of 18 months, after which it will be mandatory. Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints. It can also cancel the license of a manufacturer if it finds lapses.
Further, it gives timelines for registration and regulation of devices. For low and moderate risk devices if is 30 months from date of commencement of the rules, while for moderate high risk and high risk devices it is a period of 42 months within which it would be brought under the new regulations.
The manufacturer or importer will have to upload the generic name, model number, intended use, class of medical device, material of construction, dimensions, shelf life and brand name on the online portal of the Central Drugs Standard Control Organisation, the notification states. Once the device is registered, the manufacturer or the importer will have to mention the registration number on the device. MoHFW has specified that all such devices including instruments, apparatus, appliances, implants or other articles, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specifically on human beings or animals, will be considered for this purpose. For registration refer registration of certain medical devices at CDSO website vide G.S.R. 102(E) dated 11.02.2020.
However, Industry lobby is not comfortable with this, and were hoping that Medical devices will be considered under separate act for which NITI Aayog was also doing work.