All Medical Devices in India notified as Drugs from April 2020 onwards
India
The Indian Ministry of Health and Family Welfare has announced that all medical devices in India will be notified as drugs and regulated under the Drugs and Cosmetics Act of 1940 effective 1 April 2020. A corresponding notification was published on 11 February, which specifies the definition of medical devices as covering all instruments, apparatus, appliance or implants used for diagnosis, prevention, monitoring, treatment, or alleviation of disease or disorder, injury or disability, control of conception and life support equipment.
On the same day, changes to the Medical Device Rules (MDR, 2017) were released, which also come into force on 1 April 2020. The so-called Medical Devices (Amendment) Rules, 2020 intend to regulate all medical devices in a phased manner and mainly concern the registration and licencing procedures. All medical devices shall be registered through an online portal established by the Central Drugs Standard Control Organisation (CDSCO). Registration is voluntary for the first 18 months and will then be made mandatory. A manufacturing/import licence must be obtained within 36 months or 42 months from April 2020, depending on the risk-category of the medical device.
The MDR, 2017 which came into effect on 1 January 2018 was released by the Indian government under the provisions of the Drugs and Cosmetics Act, 1940 to provide comprehensive legislation for the regulation of medical devices. The rules are based on international regulatory practices and include a risk-based classification system. However, as of today, only 23 medical devices are notified under the MDR, 2017. The objective behind the changes notified by the Indian government is to enhance product safety by ensuring that all medical devices on the Indian market follow safety and quality standards.
The new regulation affects domestic as well as foreign manufacturers and entails changes for German medical devices companies operating in India. Within the framework of the Indo-German Working Group on Quality Infrastructure, both countries collaborate to enhance the safety of medical devices by improving the mutual understanding on standards, regulations, and compliance procedures. Challenges regarding the new regulatory framework, could be addressed within the dialogue (contact qi-india@giz.de).
Note: An ‘Update on the Current Medical Device and IVD Regulation in India’ was presented by CDSCO as part of the Annual Meeting of the Working Group on 16 January 2020 in New Delhi. The presentation is available here in the password-protected area of this website.