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The import of In Vitro Diagnostic (IVD) devices is governed by the 2017 New Medical Device Rules. For submitting applications and granting permission for import of IVD falling under any Category A, B, C, or D, the respective online form is required to be submitted on SUGAM, which is a central Licensing Authority for such products. This platform was created by the Central Drugs Standard Control Organization (CDSCO).
The CDSCO Medical Device Registration ensures that all in-vitro diagnostic devices meet the safety, quality, and efficacy standards required for the Indian market. This registration is mandatory for all IVD manufacturers, importers, and distributors operating in India. The Central Drugs Standard Control Organization (CDSCO) and the State Licensing Authority (SLA) jointly hold the approval authority.
CDSCO Medical Device Registration is mandatory for all medical device manufacturers, importers, and distributors operating in India.
Foreign manufacturers cannot directly seek registration in India as applicants. To file their Application for Registration of Imported In Vitro Diagnostic Device, they must designate an Indian Entity that is an approved agent or licence holder. The authorised agent may submit an application for an import licence to the CDSCO if they already have a wholesale licence for sale and distribution or a licence to manufacture for sale or distribution. Any business or institution that has been given a "Power of Attorney" by an international manufacturer to handle the importation of in vitro diagnostic devices into India is considered to be an authorised agent.
The applicant is required to provide a number of documents for import registration in accordance with part II of the IV schedule of the New Medical 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.
Evaluate the product to see if it complies with the fundamental standards and classify according to Product Risk category (A, B, C, or D).
Submit all necessary documents for CDSCO registration. Our team verifies and completes the documentation.
Appoint an agent through a power of attorney and prepare the application form (MD-14) with all attachments.
Submit the application through the CDSCO SUGAM portal with all required documents and fees.
Expert committees review the information and SLA submits the licence to CLAA for approval following joint verification and inspection.
Upon approval, we receive the CDSCO license (Form MD-15) and send a copy to you via email or courier.
As long as the licence retention costs are paid as specified in the second schedule prior to the license's 5-year expiration date, the import licence issued under form MD 15 stays valid indefinitely. Only if the licence has not already been suspended or revoked by the Central Drugs Standard Control Organization is this action taken.
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.
Help with appointing an Authorized Indian Representative and drafting the Power of Attorney.
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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