MEDICAL DEVICES
regulatory services
Norega team has a cumulative experience of more than 50 Years in Regulatory affairs. Over years, our experts have been Behind breakthrough Medical Devices Technology approvals by helping Medical Device companies from India and the World with a clear Regulatory Pathway for Successful Launch of their products under Medical Device Rules in India.
definition of
Medical Devices
As per New Notified definition of Medical Device Medical Device Rules 2017, Medical Device means –
- substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),
- substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;
There are 37 categories of Notified Medical Devices under these rules.
On 11th Feb 2020, CDSCO, Ministry of Health and Family Welfare further elaborated the NEW Definition of Medical Devices for the “New Notified Medical Devices”
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
This means all Medical Devices which were not notified before February 11, 2020 (i.e. other than the list of 37 categories of medical devices), and will now be covered by the new definition of medical devices.
So why are Devices defined as Drugs?Medical devices in India are regulated under the Drugs and Cosmetics Act 1940 (DCA). Within the DCA, from time to time, medical devices are first notified as drugs to come under the purview of the act. Even more so, the Medical Device Rules 2017 have also been framed under the DCA. Therefore, all medical devices are first notified as drugs under DCA so that they can ultimately be regulated under the new Medical Device Rules 2017.
INTRODUCTION TO
medical devices
There was a time when the concept of medical devices was very little in use in India. Besides, whatever equipment or systems were available, there was no control over the quality aspect and the patients at large had to suffer either because of quality or due to non availability of quality devices to treat various illness. The above difficulties were viewed seriously by the Ministry of Health and Family Welfare, Government of India and it was felt necessary to promulgate a law which would regulate the Medical devices including the intravenous diagnostic medical devices so that all Indian manufacturers and foreign suppliers can come under the Purview of the Guidelines of the said regulations issued by Central Drugs Standard Control Organisation.
Accordingly, in 2006 Government issued a law through which all types of medical devices felt necessary at that time were regulated.A provision was also kept to bring in any other advanced technology Devices and Diagnostics under the government Purview. This definitely helped the country to a large extent to get quality products. The government has been including more and more medical devices under regulation which has helped direct control on the quality products by manufacturers and exporters to India. Over the years it has been felt by the Government that prices of a lot of devices have been going up drastically and sometimes unaffordable to the population at large and the National Pharmaceutical Pricing authority also intervened and regulated the Prices of the Devices.
With the ever increasing innovation in medical devices Government has also been including many devices in the ambit of regulation for licences and as latest as on 11th February 2020, Government of India also revised the definition of medical devices through S.O. No. 648 to cover all devices under the definition of drugs.
This expansion of medical device regulations to cover all devices has now made it mandatory for registration of devices being sold in the country. The government has also given sufficient time to the Indian Manufacturers as well as Overseas suppliers to adopt to such regulations and ensure that the Indian Consumers are assured safe and quality medical device products.
2006
YEARIt became compulsory for the medical devices entering India to be in compliance with the Indian Medical Device Regulations set forth by the CDSCO
37
familiesThere are about 37 device “families” that outline the medical devices that need to be registered.
4
classesClass A -Low Risk, Class B- Low Moderate Risk, Class C – Moderate High Risk and Class D – High Risk
List of 37 categories of medical devices regulated or proposed to be regulated
Regulatory Timeline
The New Medical Devices Regulations came into Effect from January 2018 giving a Separate Regulatory identity to the Medical devices and Invitro Diagnostic Devices.To ensure Patient Safety the devices were delinked from drugs and the New medical Devices Regulations were formulated to ensure and Check Quality, Performance of Devices being sold in the country.
Sign up for email alerts
Stay current with our latest insights