Introduction: The Indian healthcare sector is rapidly expanding, with the medical device market projected to reach $290 billion by 2025. Currently, around 72% of medical devices used in India are imported. To regulate this growing industry, the Central Drugs Standard Control Organization (CDSCO) implemented the Indian Medical Device Rules, 2017. This blog provides a step-by-step guide to obtaining a CDSCO medical device import license in India.
Understanding CDSCO and Its Role: The Central Drugs Standard Control Organization (CDSCO) serves as India's National Regulatory Authority (NRA). It is responsible for the approval of new drugs, medical devices, and cosmetics, overseeing clinical trials, quality control for imports, and collaborating with state drug control organizations.
Requirements for CDSCO Medical Device Import License: To import medical devices into India, compliance with the CDSCO's Indian Medical Device Regulations is essential. The CDSCO has outlined a thorough procedure for issuing import licenses for medical devices.
Key Steps to Obtain a CDSCO Medical Device Import License:
Step 1: Register on the SUGAM Online Portal Indian agents must register on the SUGAM online portal, which is the official platform for CDSCO registrations.
Step 2: Pay the Prescribed Fees The importer or manufacturer needs to pay the applicable fees online for both the manufacturing site and the proposed devices, as determined by the CDSCO.
Step 3: Submit the Application Online Complete and submit Form MD-14 online. This includes critical 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 After completing all necessary steps and verifying the submitted documents, the concerned department will issue the Medical Import License in Form MD-15.
The Role of Agile Regulatory : The process of obtaining a CDSCO medical device import license can be intricate, with various requirements and documentation needed. Errors or omissions can lead to significant delays. Agile Regulatory in India specializes in medical device registrations and can assist you at every stage of the licensing process, ensuring a smooth and successful registration.
For further information, please visit our official website at www.agileregulatory.com to learn all about CDSCO and medical device registration for import licenses.
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