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With a significant contribution from device imports, India is currently one of the largest international markets for medical devices. Before, medical device makers in India were free to sell their products wherever. Since 2006, all medical devices entering India must adhere to the CDSCO's Indian Medical Device Regulations. For particular types of medical devices governed by the Medical Device Rules, there is currently a formal procedure for medical device registration in India.
Medical equipment and IVD (In-Vitro Diagnostics) sold in India are governed by the CDSCO (Central Drug Standard Control Organization). The State Licensing Authority (SLA) and CLA jointly hold the approval authority, while the CDSCO is led by the Drug Controller General of India (DCGI) (Center Licensing Authority). Medical device production, import, sales, and distribution in India are governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945. Therefore, in India, CDSCO Medical Device Registration is required.
CDSCO Medical Device Registration is mandatory for all medical device manufacturers, importers, and distributors operating in India.
Documents are grouped the way CDSCO reviews them — business documents, product documents, and manufacturing details.
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-7, MD-14, etc.) based on device classification and applicant type.
Submit the application through the CDSCO SUGAM portal with all required documents and fees.
For new devices without benchmark certification, expert committees review the information provided by the applicant.
SLA submits the licence to CLAA for approval following joint verification and inspection of the manufacturing facility.
Upon approval, we receive the CDSCO license and send a copy to you via email or courier.
CDSCO Medical Device License is typically valid for a period of 5 years. To maintain the registration, businesses must:
We manage every step, document, and follow-up with CDSCO so you can focus on your medical device 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.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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