New Delhi: To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry notified Tuesday medical equipment used on humans or animals as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.
The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices. The aim is to regulate all medical devices so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products, a senior official of the ministry said.
“In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the April 1, 2020,” the notification read.
Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
All devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others, will be regulated under the legislation.
At present, only 23 categories medical devices are regulated under the law.
The country’s highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB), had in April 2019 recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act. Once the notification is issued, the CDSCO will be the nodal authority to investigate complaints related to the quality and safety aspects of medical devices and can suspend the registration or cancel licences of firms.
