Medical Device Licenses Granted by CDSCO Complete List 2023
Discover the complete and up-to-date list of medical device licenses granted by CDSCO in 2023. We at MedDev Experts, cover all types of medical device licenses, including MD 5, MD 6, MD 9, MD 10, MD 15, and MD 42. Contact us today to secure your medical device license from CDSCO and ensure compliance with ease.
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The MD-5 Medical Device License is a vital document for manufacturers seeking to produce and distribute Class A or Class B medical devices in India. To obtain this license, applicants must complete Form MD-3 and comply with all applicable regulations.
The MD-5 license authorizes the manufactures to manufacture and distribute Class A and Class B medical devices, ensuring compliance with regulatory standards and facilitating the production and distribution of these medical devices.
MD-6 Medical Device Loan License: A Flexible Solution for Class A and B Device Manufacturers
The MD-6 Medical Device Loan License is a valuable solution for manufacturers looking to produce and distribute Class A or Class B medical devices without full ownership. To obtain this license, applicants must complete Form MD-4 and comply with all applicable regulations.
The MD-6 loan license temporarily grants the necessary permission to manufacture and distribute Class A and Class B medical devices, enabling businesses to meet regulatory requirements and engage in the production and distribution of medical devices without the full ownership responsibilities of a traditional manufacturing license.
The CDSCO MD-9 Medical Device License is an essential certification for manufacturers aiming to produce and distribute Class C or Class D medical devices in India.
To obtain this license, applicants must complete Form MD-7 and comply with all applicable regulations. The MD-9 license authorizes the manufacturing and distribution of Class C and Class D medical devices, ensuring compliance with stringent regulatory standards and facilitating the production and distribution of medical devices.
CDSCO MD-10 Medical Device Loan License: A Valuable Solution for Class C and D Device Manufacturers
The CDSCO MD-10 Medical Device Loan License offers a significant solution for manufacturers seeking to produce and distribute Class C or Class D medical devices without full ownership. To obtain this license, applicants must complete Form MD-8 and comply with all applicable regulations.
The MD-10 loan license authorizes the manufacturing and distribution of Class C and Class D medical devices, ensuring compliance with stringent regulatory standards while offering businesses the flexibility to engage in the production and distribution of medical devices without the burden of full ownership.
The CDSCO MD-13 Test License for Medical Devices is a vital tool for manufacturers intending to produce medical devices for clinical investigations, testing, evaluation, examination, demonstration, or training purposes.
To obtain this license, applicants must complete Form MD-12 and comply with all applicable regulations. The MD-13 test license grants the essential authorization to manufacture medical devices exclusively for these specific purposes, ensuring compliance with regulatory standards and enabling essential research and development in the field of healthcare.
The CDSCO MD-15 Import License for Medical Devices is a crucial certification for entities involved in importing medical devices into India. To obtain this license, applicants must complete Form MD-14 and comply with all applicable regulations.
The MD-15 import license authorizes the importation of medical devices, ensuring compliance with regulatory standards and facilitating the lawful importation of medical devices and in-vitro diagnostic medical devices.
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CDSCO MD-17 Import License: Essential for Importing Medical Devices for Clinical Trials and Testing
The CDSCO MD-17 Import License for Clinical Evaluation and Testing is a critical permit for organizations engaged in importing medical devices specifically for clinical investigations, testing, evaluation, demonstration, or training purposes.
To obtain this license, applicants must complete Form MD-16 and comply with all applicable regulations. The MD-17 import license authorizes the lawful importation of medical devices for these specific purposes, ensuring compliance with regulatory standards and facilitating essential research and development in the healthcare sector.
CDSCO MD-19 License: Essential for Government Institutions to Import Investigational Medical Devices
The CDSCO MD-19 License to Import Investigational Medical Device by a Government Institution is a significant authorization for government hospitals and statutory medical institutions to import investigational medical devices for patient treatment.
To obtain this license, these institutions must complete Form MD-18 and comply with all applicable regulations. The MD-19 license grants government entities the essential permission to import investigational medical devices, ensuring regulatory compliance and enabling them to provide cutting-edge and potentially life-saving treatments to patients in need. This license plays a crucial role in advancing healthcare research and patient care within government healthcare facilities.
CDSCO MD-21 Import License: Essential for Importing Medical Devices for Personal Use
The CDSCO MD-21 Import License of Medical Devices for Personal Use is a specific permission for individuals to import a small quantity of medical devices for their personal needs. To obtain this license, individuals must complete Form MD-20 and comply with all applicable regulations.
The MD-21 import license authorizes individuals to import a limited number of medical devices for their personal use, ensuring compliance with regulatory standards and enabling access to essential healthcare products for their own well-being. This license is crucial for those who require specific medical devices for personal health and well-being purposes.
CDSCO MD-23 License: Essential for Conducting Clinical Investigations of Medical Devices
The CDSCO MD-23 License to Conduct Clinical Investigation of Medical Devices is a pivotal authorization for organizations seeking to conduct clinical investigations of investigational medical devices. To obtain this license, applicants must complete Form MD-22 and comply with all applicable regulations.
The MD-23 clinical investigation license authorizes the conduct of research and clinical trials involving investigational medical devices, ensuring regulatory compliance and facilitating the advancement of medical knowledge and healthcare technology. This license is essential for organizations and researchers involved in the evaluation and development of innovative medical devices.
CDSCO MD-25 License: Essential for Assessing Clinical Performance of New In Vitro Diagnostic Medical Devices
The CDSCO MD-25 License to Conduct Performance Evaluation of New In-Vitro Diagnostic Medical Device is a crucial permission for entities seeking to assess the clinical performance of new in vitro diagnostic medical devices. To obtain this license, applicants must complete Form MD-24 and comply with all applicable regulations.
The MD-25 license authorizes the assessment and evaluation of the clinical performance of new in vitro diagnostic medical devices, ensuring regulatory compliance and contributing to the advancement of diagnostic technologies and healthcare research. This license is fundamental for organizations and researchers involved in ensuring the accuracy and effectiveness of new diagnostic medical devices.
CDSCO MD-27 License: Essential for Importing or Manufacturing Innovative Medical Devices
The CDSCO MD-27 License to Import or Manufacture New Medical Devices is a critical permission for entities seeking to import or manufacture medical devices that do not have a predicate medical device in the market. To obtain this license, applicants must complete Form MD-26 and comply with all applicable regulations.
The MD-27 license authorizes the import or manufacture of such medical devices for sale or distribution, ensuring regulatory compliance and facilitating the introduction of innovative healthcare technologies into the market. This license plays a pivotal role in advancing medical innovation and expanding the range of available medical devices.
CDSCO MD-29 License: Essential for Importing or Manufacturing New In Vitro Diagnostic Medical Devices
The CDSCO MD-29 License to Import or Manufacture New In-Vitro Diagnostic Medical Device is a crucial authorization for entities aiming to import or manufacture new in vitro diagnostic medical devices in India. To obtain this license, applicants must complete Form MD-28, the official application for the grant of permission to import or manufacture these new in vitro diagnostic medical devices for sale or distribution.
The MD-29 license provides the essential authorization to introduce new in vitro diagnostic medical devices to the market, ensuring compliance with regulatory standards and facilitating the availability of advanced diagnostic technologies to benefit healthcare providers and patients. This license plays a fundamental role in expanding the range of available diagnostic options and improving patient care.
Medical Device Licensing Authority
The Medical Device Licensing Authority is a government agency responsible for regulating the import, manufacture, sale, and distribution of medical devices. They ensure that medical devices meet safety and quality standards to protect public health.
Central Licensing Authority:
- Enforces medical device import rules for all classes
- Enforces manufacturing rules for Class C and Class D medical devices
- Approves investigational medical devices for clinical trials
- Approves new in vitro diagnostic medical devices
State Licensing Authority:
- Enforces medical device manufacturing, sale, distribution, and stock rules for Class A and Class B medical devices
- Enforces medical device rules for all classes
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