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<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>Accessing the Indian Medical Device Market<\/h2>\n
Entering the Indian medical device market requires compliance with specific regulations, overseen by the Central Drugs Standard Control Organization (CDSCO<\/a>), headquartered in New Delhi. The CDSCO is the central authority responsible for the registration and import licensing of medical devices in India.<\/p>\n
Wide Range of Products for Registration<\/strong><\/p>\n
Our services cover a variety of products that can be registered as medical devices in India, including:<\/p>\n<\/div>
<\/i><\/i><\/span>Medical Devices<\/span><\/a><\/h4><\/div>
\nAll risk classes, from A (low risk) to D (high risk).<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>In Vitro Diagnostic (IVD) Devices<\/span><\/a><\/h4><\/div>
\nIncluding all risk classes.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Drug-Device Combinations<\/span><\/a><\/h4><\/div>
\nProducts combining a drug and a device in a single entity.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>New Devices and Investigational Devices<\/span><\/a><\/h4><\/div>
\nComprehensive support for the registration of innovative and clinical research devices.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
<\/div><\/div><\/div>Registration Process: Classification, Grouping, and Requirements<\/h2>\n
Medical device registration in India involves a meticulous evaluation of the product’s risk classification, grouping, and specific requirements. Classification considers three primary factors:<\/p>\n<\/div>
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Risk-based classification:<\/strong> As per the first schedule of the IMDR 2017, devices are classified into classes A to D, with D being the highest risk.<\/p>\n<\/div><\/li>
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\nReference class:<\/strong> The device’s class in other countries, especially if considered high risk, is also taken into account.<\/p>\n<\/div><\/li>
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\nCDSCO device class list:<\/strong> The specific classification of the device in the list published by the CDSCO.<\/p>\n<\/div><\/li><\/ul>
<\/div><\/div><\/div>Comprehensive Support for Your Regulatory Project in India<\/strong><\/p>\n
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:<\/p>\n<\/div>
<\/i><\/i><\/span>Device Registration<\/span><\/a><\/h4><\/div>
\nComplete management of the registration process, from documentation preparation to obtaining the import license.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Technical Documentation<\/span><\/a><\/h4><\/div>
\nDevelopment, review, and correction of technical dossiers, ensuring compliance with CDSCO requirements.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Predicate Device Identification<\/span><\/a><\/h4><\/div>
\nAssistance in searching for and selecting similar devices already registered in India for comparison and registration purposes.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Labeling and Artwork<\/span><\/a><\/h4><\/div>
\nAdaptation of labels and packaging materials to meet IMDR 2017 and Legal Metrology Act standards.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Response to CDSCO Queries<\/span><\/a><\/h4><\/div>
\nDevelopment of clear and comprehensive responses to additional information requests from CDSCO.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Licenses and Authorizations<\/span><\/a><\/h4><\/div>
\nObtaining import licenses, test licenses, new device licenses, and Authorized Indian Agent (IAA) services.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Technical Presentation to CDSCO<\/span><\/a><\/h4><\/div>
\nPreparation and support for technical presentations to CDSCO.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Import and Customs Clearance<\/span><\/a><\/h4><\/div>
\nComprehensive advice to ensure efficient importation of your products, including customs clearance.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Distributor Identification<\/span><\/a><\/h4><\/div>
\nConnection with potential distribution partners to expand your presence in the Indian market.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>GeM Portal Support<\/span><\/a><\/h4><\/div>
\nAssistance with registration and utilization of the Government e-Marketplace (GeM) portal for government sales.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Testing in Authorized Laboratories<\/span><\/a><\/h4><\/div>
\nCoordination of testing in accredited Indian laboratories to demonstrate device conformity.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Clinical Trial Support<\/span><\/a><\/h4><\/div>
\nAssistance with all stages of clinical trials, from site and investigator identification to IEC approval, CTRI registration, and study conduct.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Medical Writing Services<\/span><\/a><\/h4><\/div>
\nDevelopment of regulatory documents such as CER, CEP, Clinical Investigation Plan, PSUR, and clinical study report.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Post-Approval Change Management<\/span><\/a><\/h4><\/div>
\nManagement of regulatory submissions for product changes after initial approval.<\/p>\n<\/div><\/div><\/div>
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