The Ministry of Health and Family Welfare on February 11, 2020 notified changes made in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.
Objective
The objective behind the above notification is to:
- Categorize all medical devices as drugs,
- Bringing medical devices under the purview of the drugs regulator, and
- Tightening regulations for them to improve safety and quality.
Features
- All medical devices, including implants and contraceptives, will be brought under the purview of the Central Drugs and Standard Control Organization (CDSCO) in a phased manner starting 1 April 2020.
- The notification re-categorize medical devices that are used for life support, diagnosis, treatment or alleviation of any disease or disability, and even devices that are used to disinfect other medical devices. These effectively cover all medical devices that are sold in the market.
- Manufacturer has to upload “name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device.
