Are you dealing with medical devices in India then must understand about sales distribution license in India. It is mandatory to obtain for all the seller and distributor of medical devices. With the help of ELT corporate medical device consultancy you can simply apply for the medical device sales distribution license.
The Medical Device Sales Distribution License (MD 42) is a regulatory requirements in India. It is necessary for the businesses that are involved in the sales, distribution and wholesale of medical devices. The medical device license is a part of medical devices rules, 2017.
The medical device rules are implemented by the CDSCO (Central Drugs Standard Control Organization) under the drugs and cosmetics act, 1940. The purpose of these rules and license ensure that medical devices in the market are safe, effective, and meet quality standards.
To obtain the license you have to understand the few more aspects that help you to boost your business and regulatory of medical devices in India. So when you applied for this then must consider all these aspects to obtain MD 42 sales and distribution license in India:
Entity such as wholesalers, distributor, or retailer involved in the sale of medical device must obtain the sales and distribution license. This includes both Class A & B devices (Low to Moderate risk.
The facility must have adequate storage space, including temperature-controlled areas for temperature-sensitive devices. The premises should comply with good storage practices to ensure the safety and efficacy of the products.
A registered pharmacist or a competent person with at least one year of experience in handling medical devices must be appointed to oversee operations.
The application fee of the MD 42 needs to be submitted as per the regulatory guidelines. The fees of the license may varies as per the state and the type of medical devices handled.
License must comply with the labeling requirements, storage standards, and maintain proper records of sales, distribution, and recalls (if applicable). The CDSCO regularly inspects premises to ensure adherence to guidelines.
The license validity is 5 years, after that it must be renewed. Renewal application should be submitted at least 3 months before the expiry date.
For the sale distribution of medical devices you must apply for it. The process to obtain sales distribution license in India as follows:
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.
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 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
The registration certificate issued in Form MD-42 is valid for 5 years from the date of issue. Before the expiry of the license you must apply for the renewal before the 2-3 months. Otherwise you may face issue in the renewal of the license.
We are proud to provide a wide range of services across the country. Our ELT Corporate 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.
