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.
Types of Medical Devices in India:
- Non-Notified Medical Devices.
- Notified Medical Devices
Unnotified Medical Equipment Non-Notified Medical Devices are those that are posted on the official CDSCO portal but are not included in the list of Notified Medical Devices. Foreign manufacturers are required to have an Indian-based IAA in order to commercialize these gadgets.
These items are on the list of medical devices that the CDSCO regulates in accordance with the Medical Devices Rules, 2017. Devices created abroad must get a Medical Device Import License, while notified devices made in India must seek a Manufacturing License from the CDSCO. Manufacturers must submit basic information, such as manufacturing site details, manufacturer, device details, FSC (Free Sales Certificate) or CFS (Certificate of Free Sales), and an undertaking by the applicant, in order for their devices to be listed on the Indian market.
Products Covered Under CDSCO- Medical Device Import License
Consumer Products
Industrial Products
Specialized Products
What requirements must be met in order to be granted a license to import medical devices?
- 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;
- Information about the trade, profession, or company the candidate typically engages in.
Procedure of CDSCO Medical Device Import License:
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.
