MD-42 Registration: A Complete Guide for Medical Device Importers in India

MD-42 registration is a crucial regulatory requirement for businesses intending to import medical devices into India. Issued under the Medical Devices Rules, 2017, the MD-42 certificate is an import license granted by the Central Drugs Standard Control Organization (CDSCO). Without this approval, importing notified medical devices into the Indian market is not permitted. As India’s medical device sector continues to grow rapidly, understanding MD-42 registration has become essential for global manufacturers and authorized Indian agents.

The MD-42 license is issued to an Authorized Indian Agent or importer who represents a foreign manufacturer. Before applying for MD-42, the applicant must first obtain a Registration Certificate in Form MD-40, which confirms the registration of the manufacturing site and the medical device. Once MD-40 is granted, the importer can proceed with the MD-42 application for import permission.

The application for MD-42 registration is submitted online through the CDSCO SUGAM portal. Applicants must provide detailed documentation, including device master file (DMF), plant master file (PMF), Free Sale Certificate from the country of origin, ISO 13485 certification, labeling details, and undertaking declarations. All documents must comply with Indian regulatory standards and be duly notarized or apostilled where required.

MD-42 registration applies to a wide range of medical devices classified under different risk categories—Class A, B, C, and D. The level of scrutiny and review timelines vary depending on the risk classification of the device. Typically, CDSCO may take several months to evaluate the application, and any deficiencies raised must be addressed promptly to avoid delays.

Once approved, the MD-42 license allows the importer to legally bring medical devices into India and distribute them as per regulatory conditions. The license remains valid perpetually, subject to payment of retention fees every five years and continued compliance with post-market surveillance, reporting of adverse events, and regulatory updates. Any change in device design, manufacturing site, labeling, or intended use must be reported to CDSCO and may require amendment approval.

Non-compliance with MD-42 requirements can result in license suspension, cancellation, penalties, or seizure of imported products. Therefore, maintaining accurate documentation, timely renewals, and regulatory vigilance is essential for long-term market presence in India.

In conclusion, MD-42 registration is a mandatory and strategic step for medical device importers seeking entry into the Indian healthcare market. While the process may appear complex, proper planning, understanding of regulatory expectations, and professional guidance can make the journey smooth and efficient.

Agile Regulatory

Agile Regulatory offers end-to-end support for MD-42 registration and other CDSCO approvals, helping medical device companies navigate India’s regulatory landscape with ease. With expert regulatory consultants, thorough documentation assistance, and proactive compliance management, Agile Regulatory ensures faster approvals, reduced risks, and seamless market entry for global and domestic healthcare businesses.

Agile Regulatory is a trusted business consultant based in Noida, India, specializing in compliance and registration services. To learn more about click on Gacc Registration.