In India if a medical device is Manufactured, Imported and sold in the market then it must be approved by the Central Drugs Standard Organisation (CDSCO). The CDSCO is a regulatory body which comes under the Directorate General of Health Services in the Ministry of Health and Family welfare, Government of India.The CDSCO has laid certain guidelines for manufacturing medical devices in India. The manufacturer has to comply with these guidelines to manufacture medical devices in India. The CDSCO classifies the devices into four classes on the basis of Potential risk associated with them. These classes are:
- Class A – Low Risk
- Class B – Moderate Risk
- Class C – Moderate High Risk
- Class D- High Risk
For a manufacturer to obtain a manufacturing license, he has to first classify his device based on the guidelines of CDSCO. After determining the risk class, he has to apply to the CDSCO Sugam portal. After the application on the Sugam portal, CDSCO will either approve or disapprove the application. CDSCO can also raise certain queries or ask for some more information from the manufacturer. There are certain forms for Class A and Class B notified medical devices. These are as follows:
- MD 3 – Application form for Manufacturer
- MD 4 – Application form for Loan License
- MD 5 – Grant License to Manufacturer
- MD 6 – Grant of Loan License
- MD 12 – Application for a test license
- MD 13 – Grant of Test License
Now, let’s see the type of licenses a manufacturer can apply for.
Manufacturing Loan License
In the case of a manufacturing loan license, you use the premises of another manufacturer who must possess the license for the same product for manufacturing. He must have all the regulatory approvals for the same. If the entity’s licenses do not meet the requirements set forth by medical device rules, it also has the authority to suspend them. The device master file must be prepared and all the relevant documents pertaining to the product need to be provided by you and the manufacturer’s details are also required.
Manufacturing License
For the Manufacturing license, you must get approval from CDSCO for your manufacturing facility and apply for the license. You would be required to share the details of your manufacturing facilities and they must comply with the infrastructure requirements specified by CDSCO. The site master file needs to be prepared as per schedule IV of MDR 2017. The test reports of the products are also required in this case.
Wholesale License
If you apply for a wholesale license no documents are required to be prepared at your end. You can market and sell these products once you receive this license. Here the details of the original manufacturer are required. To sell any medical device in India it is mandatory to have a wholesale license.
Government Fee for CDSCO Manufacturing License
The fees for a CDSCO manufacturing license in India depend on the class of medical device and the number of manufacturing sites:
- Class A and B medical devices – The fee is 5,000 INR for one manufacturing site and 500 INR for each medical device.
- Class C and D medical devices – The fee is 50,000 INR for one manufacturing site and 1,000 INR for each medical device.
The CDSCO also charges a license retention fee to maintain the validity of the license:
- Class A and B medical devices: The fee is 500 INR per medical device.
- Class C and D medical devices: The fee is 1,000 INR per medical device.
The CDSCO also has a user registration process. The authorized signatory or responsible person of the organization must fill out the registration form. After submitting the form, the CDSCO administrator will either approve or reject the request.
