The Centre has made it mandatory to have a registration certificate for the sale and distribution of medical devices to regulate the medical devices industry in the country, according to the amended Medical Devices Rules 2022. The ministry of health and family welfare made the rules public through a gazette notification last week.
“Any person who intends to sell, stock, exhibit or offer for sale or distribute 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,” read the health ministry notification regarding Medical Devices (fifth amendment) Rules 2022.
“The medical devices shall be purchased only from the importer or licensed manufacturer or registered or licensed entity.”
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The state licensing authorities have been directed to individually appoint a licensing authority dedicated to the purpose of issuing registration certificates. The state licensing authority will have the authority to either grant a registration certificate or reject the application, with reasons documented in writing. The application will have to be disposed of within ten days, the notification read.
In case of rejection, the applicant can appeal before the respective state government within forty-five days from the date of receipt of having received intimation regarding the rejection, it added.
“The amended rules have come into effect. The notification has all the details mentioned,” said a senior official, requesting anonymity.
Among the prerequisites for obtaining a registration certificate, the Centre has laid out detailed criteria that include an adequately trained person supervising sales.
“… 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:— (a) hold a degree from a recognized University/Institution; or (b) is a registered pharmacist, or (c) has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with the sale of medical devices..,” read the rules.
The applicants have been directed to maintain separate records, “in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable)”.
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These records will have to be preserved for at least two years from the last entry and will have to be open to inspection by a medical device officer.
The health ministry amended the Medical Devices rules 2017 after consultation with the Drugs Technical Advisory Board (DTAB).
DTAB is a technical advisory board of the central drugs standard control organisation consulted by the national drugs regulatory authority on all matters pertaining to the Drugs and Cosmetics Act.
“The rules are updated after following due processes, and based on the current needs and demands,” said the official cited above.