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FORM MD-3 & MD-5: License for Manufacturing Class A&B & Form MD-26 for New Medical Devices

license for medical devices

The medical device industry is one of the fastest growing and most important industries in health care that brings innovation and new technologies. The med-tech sectors make huge investments to make good quality and innovative medical devices to provide the best possible treatment to patients.  

Licensing is a vital procedure for any medical device manufacturing company to ensure that the device is free from vulnerabilities or harmful effects. Medical device licensing in India is done by Central Drugs Standard Control Organization (CDSCO). The devices are granted licenses based on their categories.  

Applications for Manufacturing Licence in India 

The companies that manufacture Class A or Class B medical devices have to go through a procedure by applying for a license to sell or distribute medical devices. These manufacturers have to apply to the State Licensing Authority for approval from the Ministry of Health and Family Welfare's online portal, depending on the applicant's location. In India, form MD-3 and Form MD-5 are required to obtain permission to manufacture Class A-B medical devices. Apart from these forms differ based upon the intended purpose of application.  Form MD-26 is the manufacturing license of innovative or new medical devices being registered for the first time in India. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants permission to manufacture/import new medical devices in India.  

What is MD-3, MD-5 & MD-26? 

MD-3 is the application form. By this application form, an MD-5 license is given to manufacturers for a license to manufacture and sell Class A or Class B Medical Devices. 

Form MD-26 is the application form through which manufacturers can get permission from CLA either for manufacturing/importing medical devices that do not have predicate devices in India 

The next steps

After the collection of the required documents, below are the steps that are to be followed: 

Inspection of Application

It is one of the most important steps of the process as if any shortcoming/discrepancy is noted, a query shall be raised. The application moves forward when the reply to the query is received from the applicant. 

Audit of applicant premises

After the successful scrutinizing of the application, an audit report and the notification of closure of the applicant’s premises are prepared by the Central Drugs Standard Control Organization (CDSCO).  

After the audit report is submitted, it is reviewed and if found acceptable, it is moved forward for further process. 

Scrutiny of the products

The products for which the application is applied are then evaluated. If they are found in accordance with the norms, the application will be considered for grant of a license 

The permit of license

The license is granted with the validity of 5 years on the attainment of all the laid down prerequisites  

Form MD 26 license

How Rihim Pharma can help? 

Rihim Pharma has a team of experts that can help in the pre-screening of all the documents that are needed to make sure that they are free from any errors or need any updates necessary according to India’s updated norms or recent changes. 

Although manufacturers can collect all the documents to be submitted but knowing the correct way of presenting information is also a necessity. We can help you in the pre-screening of the application before its submission so that it is free from any disparity and can help you to reply back in case any queries are raised on the application and resolve any non-compliances with the application.  

Any individual or company involved in the manufacturing of medical devices needs to obtain a manufacturing license for medical devices. Sometimes, this can be a tedious process for them. Rihim Pharma has a technical team that helps manufacturers to study their products to create the best possible route, making the approval process easier for the manufacturers. 

We have a redesigned checklist and processes that have simplified the registration formalities for the clients to make the process smooth which ultimately speeds up the timeline for getting the approvals. To know more, connect with our team at info@rihimpharma.com


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