ON September 30, the Ministry of Health and Family Welfare published the Medical Devices (Fifth Amendment) Rules, 2022, through which it notified a new rule, 87A which deals with registration certificates to sell, stock, exhibit or offer for sale or distribute a medical device, including in vitro diagnostic medical devices. With the amendment coming into effect, all store owners selling thermometers, condoms, face masks, spectacles, or any other medical device will now have to get registered with the state licensing authority.
In exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the central government, after consultation with the Drugs Technical Advisory Board, further amended the Medical Devices Rules, 2017. Under the new rules:
• The state licensing authority shall appoint licensing authorities for the purpose of issuing registration certificates under this part for such areas as may be specified.
Any person who intends to sell, stock, exhibit or offer for sale or distributes a medical device, including in vitro diagnostic medical device, shall make an application in Form MD-41 to the state licensing authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution. The application needs to contain details of the applicant or firm, including its constitution, along with identification proof, such as, Aaadhar card or PAN card, along with documentary evidence in respect of ownership or occupancy on rental of the premises. It also requires details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:
• holds a degree from a recognized university/institution; or
• is a registered pharmacist; or
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