Health ministry issues notification to regulate all medical devices under D&C Act from April 1, 2020
Union health ministry has notified that all medical devices will now be regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for effective compliance.
The ministry after consultation with Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and has specified that these rules may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020.
According to a Gazette Notification dated February 11, 2020, after consultation with DTAB, the health ministry hereby specifies that all medical devices intended for use in human beings or animals will be regulated as drugs with effect from the April 1, 2020, which includes all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist 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 disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.”
The notification further states, “In the Medical Devices Rules, 2017 (hereinafter to be referred as said Rules), after Chapter III, the following Chapter IIIA shall 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 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 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 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.”
Comments
Post a Comment