Feb 11, 2020: Union health ministry has notified that all the medical devices will nowadays regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for efficient compliance.
“The ministry after consultation with the Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and precised that these rules may be called the Medical Devices (Amendment) Rules, 2020 and will come into force on April 1, 2020.
According to a Gazette Notification dated February 11, 2020, after consultation with the DTAB, the health ministry hereby specifies that all the medical devices that are intended for use in human beings or animals will be regulated as drugs with effect from the April 1, 2020, which includes all the devices including an instrument, apparatus, implant, appliance, material or other article, whether used alone or in combination, also including a software or an accessory, intended by its producer to be used particularly for the human beings or animals which does not attain the primary intended action in or on human body or animals by any the pharmacological or immunological or metabolic means, but which may help 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 the disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation and assistance for, any injury or disability; (iii) investigation, replacement or modification or support of anatomy or of a physiological process; (iv) supporting or satisfying life; (v) disinfection of the medical devices; and (vi) control of the conception.”
The notification further states that “In the Medical Devices Rules, 2017 (here in after to be referred as said Rules), after Chapter III, the following Chapter IIIA will be inserted, namely-“Chapter IIIA Registration of certain Medical Devices 19a. This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Eighth Schedule of these rules. The Medical devices referred to in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO) for this purpose.
The notification also states that any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO for this purpose. The importer shall upload the name of the company or firm or any other entity importing the medical device and specification and standards of that medical device and also details of the medical device. Welcoming the move, Pavan Choudary, chairman and director-general, Medical Technology Association of India (MTaI) said, “We welcome the government’s decision to regulate all devices. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for 2 years, are in line with the government’s vision to provide equitable access to quality healthcare. It is also noteworthy that health ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring.”
file:///E:/website%20matter/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf
