The healthcare sector holds a vital position in safeguarding the health of a nation's people, with the utmost importance placed on the safety and effectiveness of medical devices. In India, the Central Drugs Standard Control Organization (CDSCO) functions as the regulatory body entrusted with the responsibility of guaranteeing that medical devices introduced to the market adhere to the essential quality and safety criteria and oversees medical device registration in India. To accomplish this objective, CDSCO issues a range of licenses for the approval of medical devices. This blog will delve into these licenses and provide insights into the regulatory structure governing medical devices in India.
CDSCO issues import licenses for the medical device registration in India and importation of medical devices manufactured in foreign production facilities. An authorized agent, holding a license for manufacturing, distribution, or wholesale distribution, is required to submit an application for the issuance of an import license to the Central Licensing Authority through the online SUGAM portal.
The Central Licensing Authority (CLA) will provide a review response within a period of nine months from the application date. The licensee must also include the overseas manufacturer who has granted power of attorney in favor of the authorized agent.
Once granted, a license remains valid indefinitely, unless it is canceled or voluntarily surrendered. However, the authorized agent must deposit the license retention fee with the Central Licensing Authority for each overseas manufacturing site and for each licensed medical device every five years from the date of issuance.
To produce medical devices in India, it is imperative to obtain a Manufacturing License from CDSCO for medical device registration in India. This license is provided to facilities that satisfy rigorous quality criteria and possess the essential infrastructure and technical competence for the safe and efficient production of medical devices. Manufacturers are obligated to adhere to the Good Manufacturing Practices (GMP) set forth by CDSCO.
A loan license for registration of medical devices in India enables the licensee to utilize an existing license holder's manufacturing facility to produce specific medical devices. This license is granted when the licensee lacks their own manufacturing facility or sterilization capabilities. To secure a loan license, the licensee must choose a manufacturer who already possesses a manufacturing license. Loan licenses for various classes of medical devices are issued by the appropriate licensing authority, either the State Licensing Authority (SLA) for Class A and Class B devices or the Central Licensing Authority (CLA) for Class C and Class D devices. The process entails the submission of the relevant application forms, and upon approval, the licensee can utilize the designated facility to manufacture the specified medical devices.
Entities wishing to market medical devices in India must acquire a Sales License. This license guarantees that medical devices are distributed through authorized channels and that distributors and retailers adhere to legal requirements. It additionally safeguards the safe delivery of devices to end-users and preserves their quality as they traverse the distribution network.
Test License for manufacturing
CDSCO issues a Test license, allowing the manufacturing of a limited quantity of Class A, Class B, Class C, or Class D medical devices for purposes such as clinical investigations, testing, evaluation, examination, demonstration, or training. To obtain this license, applicants must submit an application using Form MD-12 to the Central Licensing Authority and include the required fee.
Upon satisfying the necessary criteria, the Central Licensing Authority will grant a test license in Form MD-13 within thirty days from the date of application. This license remains valid for a duration of three years from its date of issuance unless it is revoked. The licensee is obligated to maintain a record detailing the quantity of products manufactured under the test license.
Test License for Importation
The CDSCO grants a Test license for the import of medical devices, including In-Vitro Diagnostic medical devices, for the purposes of testing, evaluation, clinical investigations, demonstration, or training. To obtain this import license for testing, evaluation, demonstration, or training, the importer is required to submit an application in Form MD-16 to the Central Licensing Authority along with the appropriate fee. The Central Licensing Authority will assess the quantity of medical devices to be imported, considering factors such as the clinical investigation requirements, the approved clinical investigation plan, and the information and documents provided by the applicant.
Free Sale Certificate
A Free Sale Certificate, issued by CDSCO, serves as confirmation of the quality and safety of medical devices produced in India and earmarked for overseas export. This certificate acts as evidence that these devices comply with the regulatory standards of the destination country.
Navigating the regulatory landscape for medical devices in India can be complex, given the diverse range of products and the need for rigorous safety and quality standards. CDSCO's issuance of various types of medical device registration approval licenses helps ensure that only safe and effective medical devices are made available to the Indian population. Stakeholders, including manufacturers, importers, and distributors, must understand and comply with these regulations to contribute to the improvement of healthcare quality and patient safety in India. As the medical device industry continues to evolve, staying informed about regulatory updates and requirements is essential for all players in this critical sector.
If you have any further questions or need assistance with medical device approvals in India, don't hesitate to contact Artixio, your trusted partner in regulatory compliance. We're here to help you navigate the intricacies of the Indian healthcare market and ensure your products meet all necessary requirements. Reach out to us today for expert guidance and support.
As the medical device industry continues to evolve, staying informed about regulatory updates and requirements is essential for all players in this critical sector. Let Artixio be your partner in achieving compliance and success in the medical device registration in Indian market.