There cannot be any denial of the fact that one sector that has tremendously benefitted from the advancement of science and technology is the healthcare and medical sector. The use of technology in the medical sector has not only enabled faster and smoother access towards cure and treatment of various ailments but has also aided in successful treatment of patients around the world. Medical devices are one such innovation which have not only relieved those suffering from severe medical conditions but have in several cases also increased the life span of patients.
Legal framework
In India the commercialization of medical devices is regulated under the provisions of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”) and the Medical Devices Rules, 2017 (hereinafter referred to as the “Rules”) to ascertain that the products being sold are complying to the accepted standards thereby instilling confidence amongst the consumers.
Amendments to Medical Devices Rules, 2017
The legislature has introduced further amendment to the Rules in order to facilitate the sale of good quality medical devices vide notification dated February 11, 2020[1] (hereinafter referred to as the “notification”). Some of the key features of the said amendment are listed as under:
What is a medical device?
As per the notification[2], medical devices (Section 3(b)(iv) of the Act) include 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;
- diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- investigation, replacement or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception
Registration of medical devices
[3]
The manufacturers as well as importers of the medical devices are required to submit relevant details in the application to the Central Drugs Control Standards Organization (hereinafter referred to as “CDSCO”) including but not limited to:
- Generic Name
- Intended Use
- Class of Medical device
- Material of Construction Dimension
- Shelf Life
- Brand Name (if registered under the Trade Marks Act, 1999)
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