CDSCO- Medical Device Import License

Importing medical devices into India is essential for all manufacturers. Manufacturers must meet all efficacy and quality requirements to be allowed to import into India. The distribution, sale, manufacture, and import of drugs, cosmetics, medical devices, and IVDs are governed in India by the laws.
The DCGI ignores the regulatory oversight that the Central Government has over certain items that are imported into India via CDSCO. The State Drug Control Authorities, who are chosen by the State Governments, are principally in charge of regulating the production, distribution, and sale of medical devices. Getting a Medical Device Import License in India is primarily about making sure that safe, effective, and high-quality medical equipment that are founded on the finest regulatory standards & scientific brilliance are available.

Products Covered Under CDSCO- Medical Device Import License

What requirements must be met in order to be granted a license to import medical devices?

1. Whether the spaces, buildings, or locations where the imported materials will be kept are equipped with adequate storage facilities to maintain the characteristics of the medicine for which the import license is valid;
2. Information about the trade, profession, or company the candidate typically engages in.

Procedure of CDSCO Medical Device Import License:

The importer, manufacturer, or their agent in India must submit an application in Form MD-14 for the CDSCO Medical Device Import License in India, pertaining to the premises and devices made by the manufacturer and intended for import into India.

The CDSCO Medical Device Import License cost for the location or units where the manufacturer is producing the devices intended for import must be paid in addition to the application.

In addition, there is a charge for the Single Device Registration in India, which allows for variations in sizes or shapes without affecting the material or method of use. There is also an additional fee for each new device.

Validity of the License to Import Medical Devices

Form MD15 grants permission to import medical devices in perpetuity, meaning that as long as the license retention fee is paid periodically, the authorization to import will be valid. Unless the Central Licensing Authority (CLA) suspends or cancels the license, the license retention must be paid each time before the five-year term from the date the import license was issued.

Who Can Apply

For the same, an Authorized Indian Agent needs to be designated. In accordance with CDSCO requirements, this agent needs to hold a manufacturing license (for sale or distribution) or a wholesale license (for sale or distribution). The agent will submit an application to be granted permission to import medical devices.