How to Obtain CDSCO Medical Device Import License in India?

Introduction:

The Indian healthcare sector is experiencing rapid growth, with the medical device market expected to reach $280 billion by 2025. Despite this, India still relies on imports for approximately 70% of its medical devices. To regulate this sector, the Central Drugs Standard Control Organization (CDSCO) introduced the Indian Medical Device Rules, 2017. This informative blog will guide you through the process of obtaining a CDSCO medical device import license in India.

Understanding CDSCO and its Role:

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) in India, responsible for the approval of new drugs, medical devices, and cosmetics. It is also involved in clinical trials, quality control of imported drugs and medical devices, and coordination with state drug control organizations.

Requirements for CDSCO Medical Device Import License:

To import medical devices into India, compliance with CDSCO's Indian Medical Device Regulation is mandatory. The CDSCO has established a comprehensive procedure for issuing import licenses for medical devices.

Here are the key steps to obtain a CDSCO medical device import license:

Step 1: Register on the SUGAM Online Portal:

Indian agents must register themselves on the SUGAM online portal, which is a designated platform for CDSCO registrations.

Step 2: Pay the Prescribed Fees:

The importer or manufacturer must pay the required fees online for the manufacturing site and the proposed devices. The fee amount is determined by the CDSCO.

Step 3: Submit the Application Online:

Complete and submit Form MD-14 online, providing essential information about the applicant, product details, power of attorney, relevant certificates, and a Device and Site Master File.

Step 4: Issuance of the Medical Import License:

Once all the necessary steps have been completed and the submitted documents are found satisfactory, the concerned department will issue the Medical Import License in Form MD-15.

The Role of Regulatory Solutions India:

Navigating the CDSCO medical device import license process can be complex, with various requirements and documentation involved. Mistakes or omissions can result in costly delays. Regulatory Solutions India offers expertise in medical device registrations and can guide you through each step of the licensing process, ensuring a smooth and successful registration.