A Sales Distribution License refers to the authorization or permission granted by a governing body or regulatory authority that allows an entity or individual to distribute and sell specific goods or products within a particular region, jurisdiction, or market.
New Regulation From The Ministry Of Health Family Welfare
On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOhFW) issued GSR 754(E) announcing new sales distribution license 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 authorized agents/sellers/retailers who want to import, sell, stock, exhibit or distribute medical devices and in vitro diagnostic medical devices in India.
Traditional Requirement Of Wholesale & Retail Drug Licence Has Been Removed: New Medical Device Sales Distribution License Under MD-42
According to the new rule mentioned above, a separate license is required for Medical device wholesalers/Retailers in Form MD -41, and a Final ‘sales and distribution license’ shall be granted in Form MD-42. Under the new system of licensing the requirement of a Competent Person has been waived. Earlier the Competent Person should be a Bachelor of Pharma or a diploma in Pharma but now any person who graduated in any field but has relevant experience in selling medical devices can be a fit person for the compliance of obtaining selling and distribution license of medical devices.
New Sales Distribution License Is Granted At The State Government Level (Respective State FDA)
Each state’s licensing authorities shall appoint a licensing authority designated only to issue Sales Distribution License 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 license 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 the medical device dealer or manufacturer is doing billing from multiple States then he will be required to obtain distinct selling and distribution license from each respective state in which he is doing billing.
Process Of Obtaining Selling And Distribution Licence
Step 1 – Make the CDSCO Portal by registering online and submitting the physically self-attested papers to the Public Relations Office (PRO) of the CDSCO Office.
Step 2 – All the relevant documents must be submitted as prescribed under the regulations. 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 submitted to the State
Step 3 – The government authority will scrutinize the documents submitted and may raise objections.
Step 4 – Get Clear the objections by submitting appropriate replies/information to the government authorities.
Step 5 – Based on the 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.
Step 6 – After getting success from all the above steps, the applicant gets registration to sell and distribute medical devices under form MD-42
Physical Inspection By State FDA Authorities
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 for storing medical devices as prescribed under the law or if anything is found in contravention of the law, the authorities may reject the application.
Post Obtaining License To Sell & Distribute Medical Devices Following Compliances Has To Be Adhered With
The owner of a medical device 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
List Of Documents Required For Application Of MD-41
- 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.
- A brief description of other activities carried out by the 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 concerning 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, Premise Plan, etc.
Validity Of Sale And Distribution Licence Of Medical Device
The registration certificate issued in Form MD-42 is valid for 5 years from the date of issue.
How Will ELT MediLaw Assist You?
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