Last Updated on January 6, 2024 by The Health Master
Download notification No. GSR 754(E) dated September 30, 2022, the link is given below: The Ministry of Health and Family Welfare (MoHFW) has issued a final notification vide no. GSR 754(E) dated 30/09/2022, amending the Medical Devices Rules, 2017 to introduce a registration certificate for the sale premises of medical devices, to regulate the traders of medical devices, including in vitro diagnostic devices and those that are sold in premises other than pharmacies.
According to the final notification in Medical Devices Rules, 2017, in rule 34, which is on the procedure to apply for a grant of import license where eligibility for application is provided for an authorized agent having a license to manufacture for sale or distribution or wholesale license for sale or distribution, the MoHFW has inserted the provision for those who have the registration certificate in Form MD-42 to also apply for the import license.
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Similarly, in Rule 87, which deals with the provisions for the sale of medical devices, a sub-rule has been inserted to mandate that any person who does not hold a license under sub-rule (1) and intends to sell medical devices exclusively as referred to in clause (ZB) of Rule 3 (which includes in vitro diagnostic and surgical dressings, among others), shall obtain a registration certificate as provided in these rules.
Besides, in the same rule, the Ministry has also inserted provisions for issuing registration certificates to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices.
The State Licensing Authority shall appoint licensing authorities for the purpose of issuing registration certificates for such specific areas.
Those who want to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices, shall make an application in Form MD-41 to the State Licensing Authority for the grant of registration certificate for the same with specific certificates and documents.
It also specifies the conditions of the registration certificate for the sales or distribution of medical devices, which mandates that the certificate holder shall provide adequate space and proper storage conditions for storage of the medical devices, shall maintain the requisite temperature and lighting as per requirements of such medical devices, and the medical devices shall be purchased only from the importer or licensed manufacturer or registered or licensed entity, among others.
It has also introduced Form MD-41 to apply for a registration certificate to sell or distribute devices, including in vitro diagnostic devices, and Form MD-42, in which the State Licensing Authority shall grant the registration certificate or reject the application for reasons to be recorded in writing, within ten days from the date the application is made.
The amendment also inserts a Form MD-43 in which the inspection book shall be maintained.
The registration certificate, issued on Form MD-42, shall remain valid in perpetuity, subject to payment of the registration certificate retention fee as specified in the Rules, before completion of the five-year period from the date of its issue.
The provision also imposes a late fee calculated at the rate of two percent of the retention fee for every month if the certificate holder fails to pay the retention fee on or before the due date.
The fee for the registration certificate and the retention fee is fixed at Rs. 3,000 each.
If the certificate holder contravenes any provision of the Act or the Rules, the State Licensing Authority shall, after giving an opportunity to show cause as to why such an order should not be passed, suspend or cancel the certificate by an order for reasons to be recorded in writing.
The certificate holder, if he gets such a suspension or cancellation order, shall approach the state government within forty-five days of the receipt of the order.
The state government has the power to confirm, reverse or modify such order, with reasons to be recorded in writing.
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