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The production of in-vitro diagnostic tools, kits, and reagents is governed by the Drug and Cosmetic Act of 1940 and Rules of 1945. (IVD). Before, India lacked any provisions for the registration of IVD. However, in 2017 the Indian government released an official announcement for the registration of IVD and medical devices. Under the New Rules of the Government of India, there are a total of 462 Products classed as medical devices and 250 Products as IVD.
A disease or other health condition can be diagnosed using in vitro diagnostic technologies, which include kits, reagents, tools, and systems. This includes determining one's overall health in order to treat, cure, or prevent disease or its complications. These goods are designed to be used in the collecting, preparation, and analysis of human body specimens.
CDSCO Medical Device Registration is mandatory for all medical device manufacturers, importers, and distributors operating in India.
Medical Device Rules of 2017 classify In-Vitro Diagnostic Devices based on risk parameters.
According to Part II of the First Schedule of the Medical Device Rule 2017's Parameter Notified in Chapter II, Rule 4, Sub Rule (2), the IVD are classed as under:
The applicant is required to provide a number of documents for manufacturing registration in accordance with the Medical Device Rules of 2017.
Each stage is a real, sequential step through the CDSCO Medical Device Registration process under the Medical Device Rules, 2017.
Get in touch with our experts to discuss your CDSCO Medical Device Registration requirements and product type.
Submit all necessary documents for CDSCO registration. Our team verifies and completes the documentation.
Prepare the appropriate application form (MD-3, MD-4, MD-7, or MD-8) based on device classification and applicant type.
Submit the application through the CDSCO SUGAM portal with all required documents and fees.
The Authority scrutinizes the application and audits the applicant premises by a notified body. Any non-compliance must be fixed.
The specifics of the products submitted are examined. If the products meet all standards and rules, the application is considered for license grant.
Upon approval, we receive the CDSCO license (Form MD-5/MD-6/MD-9/MD-10) and send a copy to you via email or courier.
The license is valid indefinitely but requires compliance with periodic audits and regulatory requirements. Non-compliance may result in suspension or cancellation. To maintain the registration, businesses must:
We manage every step, document, and follow-up with CDSCO so you can focus on your medical device manufacturing business.
We verify your eligibility and ensure all required documents are complete and valid.
Complete application form drafting and verification to ensure error-free submission.
Consulting on medical device classification (Class A, B, C, D) and specific CDSCO requirements.
Complete CDSCO application filing through the SUGAM portal.
We respond to all queries from CDSCO on your behalf.
A full compliance schedule including renewal reminders and annual return filing.
A single point of contact for questions throughout the entire process.
Guidance on preparing your manufacturing facility for CDSCO inspections and audits.
Assistance with post-license compliance, renewals, and regulatory updates.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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