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Accessing the Indian Medical Device Market

Entering the Indian medical device market requires compliance with specific regulations, overseen by the Central Drugs Standard Control Organization (CDSCO), headquartered in New Delhi. The CDSCO is the central authority responsible for the registration and import licensing of medical devices in India.

Wide Range of Products for Registration

Our services cover a variety of products that can be registered as medical devices in India, including:

All risk classes, from A (low risk) to D (high risk).

Including all risk classes.

Products combining a drug and a device in a single entity.

Comprehensive support for the registration of innovative and clinical research devices.

Registration Process: Classification, Grouping, and Requirements

Medical device registration in India involves a meticulous evaluation of the product’s risk classification, grouping, and specific requirements. Classification considers three primary factors:

  • Risk-based classification: As per the first schedule of the IMDR 2017, devices are classified into classes A to D, with D being the highest risk.

  • Reference class: The device’s class in other countries, especially if considered high risk, is also taken into account.

  • CDSCO device class list: The specific classification of the device in the list published by the CDSCO.

Comprehensive Support for Your Regulatory Project in India

Passarini Group offers a comprehensive suite of services to ensure the success of your medical device project in India, from initial registration to post-approval support. Our experts are poised to assist you at every stage of the regulatory process, including:

Complete management of the registration process, from documentation preparation to obtaining the import license.

Development, review, and correction of technical dossiers, ensuring compliance with CDSCO requirements.

Assistance in searching for and selecting similar devices already registered in India for comparison and registration purposes.

Adaptation of labels and packaging materials to meet IMDR 2017 and Legal Metrology Act standards.

Development of clear and comprehensive responses to additional information requests from CDSCO.

Obtaining import licenses, test licenses, new device licenses, and Authorized Indian Agent (IAA) services.

Preparation and support for technical presentations to CDSCO.

Comprehensive advice to ensure efficient importation of your products, including customs clearance.

Connection with potential distribution partners to expand your presence in the Indian market.

Assistance with registration and utilization of the Government e-Marketplace (GeM) portal for government sales.

Coordination of testing in accredited Indian laboratories to demonstrate device conformity.

Assistance with all stages of clinical trials, from site and investigator identification to IEC approval, CTRI registration, and study conduct.

Development of regulatory documents such as CER, CEP, Clinical Investigation Plan, PSUR, and clinical study report.

Management of regulatory submissions for product changes after initial approval.

Monitoring and reporting of adverse events to CDSCO, ensuring patient safety.

Preparation and submission of Periodic Safety Update Reports, as required by regulations.

View Complete Flowchart of Registration Process Steps in India

Fluxo Etapas PT Processo India CDSCO

Contact Passarini Group for a detailed flowchart of the registration process and specific examples for your product.

Our experts will guide you through every step, ensuring your medical device is registered efficiently and in full compliance with Indian regulations.