India: According to the updated Medical Devices Rules 2022, the Center has made it necessary to have a registration certificate for the sale and distribution of medical devices in order to regulate the industry in the nation. The rules were published in the gazette last week by the ministry of health and family welfare.
The Medical Devices (fifth amendment) Rules 2022 notification from the health ministry stated that “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.”
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“The medical devices shall be purchased only from the importer or licensed manufacturer or registered or licensed entity.”
A licencing authority designated specifically for the purpose of providing registration certificates must be appointed by each state’s licencing authorities. The state licencing body will have the power to approve or reject the application, with written justifications for each decision. The notification stated that the application must be rejected within 10 days.
In the event of rejection, the applicant may file an appeal with the appropriate state government within 45 days of receiving notice of the decision, it was said.
“The revised regulations are now in effect. All of the information is included in the notification, according to a senior source who asked to remain anonymous.
The Centre has outlined specific requirements for acquiring a registration certificate, some of which include having a supervisor who is properly trained.
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“… details of qualified technical staff, under whose direction and supervision the sales activity of medical devices shall be undertaken, who shall possess the following educational qualification and experience, namely— (a) hold a degree from a recognised University/Institution; (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.”
The applicants are required to keep separate records of their purchases and sales of medical devices, “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).”
A medical device officer must be able to inspect these records, which must be kept for at least two years after the last entry.
After consulting with the Drugs Technical Advisory Board (DTAB), the Health Ministry modified the Medical Devices Rules of 2017.
The national drugs regulatory authority consults the DTAB, a technical advisory body of the central pharmaceuticals standard control organisation, on all issues relating to the Drugs and Cosmetics Act.
According to the official stated above, “the rules are amended after following necessary processes, and depending on the current needs and desires.”
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