On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOhFW) issued GSR 754(E) announcing new sales licence requirements for entities importing and distributing formerly medical devices.
This new legislation, referred to as the Medical Devices (Fifth Amendment) Rules, 2022, is meant for authorised agents/sellers/retailers who want to import, sell, stock, exhibit or distribute medical devices and in vitro diagnostic medical devices in India.
According to new rule mentioned above ,seperate licence is required for Medical device wholesalers/Retailers in Form MD -41 and Final ‘sales and distribution licence’ shall be granted in Form MD-42. Under the new system of licensing the requirement of Competent Person has been waived off. Earlier the Competent Person should be a Bachelor of Pharma or diploma of Pharma but now any person graduated in any field but having relevant experience to sell the medical devices can be a fit person for the compliance of obtaining selling and distribution licence of medical devices.
Each state’s licensing authorities shall appoint a licensing authority designated only for the purpose of issuing registration certificates. The state licensing body will have the authority to accept or reject the application and each decision will be supported by written documentation.
The power of selling and distribution licence of medical devices is vested with the respective state government from B from which the medical device dealer or manufacturer I will do the building and gif the medical device dealer or manufacturer is is doing billing from multiple States then he will be required to obtain distinct selling and distribution licence from each respective state in which he is doing billing.
Make the CDSCO Portal by registering online and submitting the physically self attested papers in the Public Relation Office (PRO) of the CDSCO Office.
All the relevant documents must be submitted as prescribed under the regulations.the Everyone who wants to sell, stock, offer for sale, or distribute medical devices, including IVD, must submit an application to SLA in Form MD-41 along with the Fee of Rs. 3000 is submitted to the State
The government authority will scrutinise the documents so submitted and may raise objections.
Get Clear the objections by submitting appropriate reply/information to the government authorities.
On the basis of above, the government authorities will accept or reject the application, if it got rejected then the applicant can appeal before the respective state government within 45 days from the date of receipt of having received intimation regarding the rejection.
After getting the success from all above steps, the applicant gets registration to sell and distribute medical devices under form MD-42
This state FDA authority has the power to inspect the premises of medical device Importer for the manufacturer, as the case may be.
At the time of inspection the applicant must be able to demonstrate the required papers and the arrangements of storing medical devices as prescribed under the law or if anything found in contravention of the law, the authorities may reject the application.
The owner of a registration certificate must keep an inspection book in form MD-43.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
Details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card.
Documentary evidence in respect of ownership or occupancy on rental of the premises.
Educational Qualification Details of competent technical staff.
Experience Details of competent technical staff.
Brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises.
Self-certificate of compliance with respect to Good Distribution Compliance.
An undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device .
Any Other Documents like GST, Trade License, and Premise Plan etc.
The registration certificate issued in Form MD-42 is valid for 5 years from the date of issue.
We are proud to provide a wide range of services across the country. Our ELT Medilaw team is well versed in standards of regulatory affairs,enabling the clients to help them in selling and distributing their medical devices in the whole country without any compliance difficulties.
We have depth & breadth of understanding and nexus in the regulatory ecosystem across national and internationally. ELT believes in the value of customer satisfaction as its utmost priority and to enable the rendering of service in the most smooth manner.
