Centre notifies medical equipment used on humans or animals as 'drugs'

New Delhi: To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry on Tuesday notified medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.

Medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.

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 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 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.

More so, the ministry, through a gazette notification, released Medical Devices Amendment Rules, 2020, for the registration of 36 medical devices.

The medical devices referred shall be registered with the central licensing authority via an online portal established by the CDSCO for the purpose.

The manufacturer of a medical device or any person who imports any medical device will have to upload the information related to that medical device for registration on the "Online System for Medical Devices" established by the CDSCO for this purpose.

According to the notification, the manufacturer or the importer will have to upload name and 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, details of medical device like generic name, model no, intended use, shelf life and certificate of compliance with respect to ISO 13485 standard accredited by the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF) among others undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.

Manufacturer or importer will also have to mention the registration number on the label of the medical device, it said.