(4.8)
The Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare, is responsible for enforcing rules and monitoring medical device imports in India. Following specific regulations and acquiring the required licences are requirements for importing medical equipment into the nation.
CDSCO Medical Device Import License is a legal requirement for entities seeking to import medical devices into India. This license ensures that imported medical devices comply with India's regulatory standards established by CDSCO.
According to CDSCO regulations, the person who requires a license to manufacture/import (for sale or distribution) or a wholesale licence (for sale or distribution), will submit an application to get authorization for the Import of Medical Devices.
Medical Devices must first be properly classified based on their intended usage, level of risk, and other factors. The type of classification will establish the particular specifications and laws that apply to your medical product. There are four types of Medical Device Classes:
The appointment of an authorised Indian agent, who acts as an intermediary between the manufacturer and the Indian regulatory authorities, is necessary for non-resident manufacturers.
We must put the technical documentation of the medical devices which includes their performance, specifications, design, and intended usage. This paperwork is necessary need to show that your product satisfies all the quality and safety regulations.
Various documents need to be submitted Medical Device Import License:
Prepare a comprehensive application dossier that includes all necessary documentation. The application should be submitted to the CDSCO along with the prescribed fees.
CDSCO may conduct a Quality Management System audit of the manufacturing facility to ensure that the facility adheres to Good Manufacturing Practices (GMP) and other quality standards.
CDSCO reviews the application dossier and assesses the submitted documentation. If everything is in order and compliant with the regulations, the CDSCO issues the Medical Device Import License.
Depending on the risk classification of your medical device, you may need to obtain regulatory approvals such as registration certificates or licenses from CDSCO. Some devices may require additional clearance from specialized committees.
With the license in hand, you can proceed with importing Medical Devices into India. It's essential to comply with post-market surveillance requirements and promptly report any adverse events related to the imported devices.
The authorization to import medical devices, granted in Form MD-15, is valid forever, or as long as the licence retention cost is periodically paid. Unless it is suspended or revoked by the Central Licencing Authority (CLA), the license retention fee must be paid each time before a period of 5 years from the date the Import license was issued.
Obtaining a CDSCO Medical Device Import License is important for ensuring that the medical devices imported into India are safe for use. Navigating the regulatory landscape can be complex, but with the right understanding of the process and compliance with the requirements, businesses can successfully import and distribute medical devices in the Indian market while upholding the highest quality and safety standards. Get a CDSCO Medical Device Import Registration with expert guidance from Agile Regulatory. We completed the project within the given timeframe with a smooth collaborative approach.
Nishi Chawla
11 Jul, 2025
Nishi Chawla
11 Jul, 2025
Nishi Chawla
09 Jul, 2025
Nishi Chawla
09 Jul, 2025
Nishi Chawla
08 Jul, 2025
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