Documents Required for a Medical Device Loan License

The Central Drugs Standard Control Organisation (CDSCO) is India's leading regulatory authority. It operates under the Directorate General of Health Services within the Ministry of Health and Family Welfare and is a crucial entity of the Government of India responsible for drug and medical device regulation.

A CDSCO Test License for Medical Devices is a regulatory approval process designed to ensure the safety and quality of medical devices, drugs, pharmaceuticals, and cosmetics. This license certifies that products meet the required standards set by the Central Drugs Standard Control Organisation (CDSCO), facilitating compliance and enhancing product reliability. For more details, visit CDSCO Drugs Import License.

What is a CDSCO Loan License for Medical Devices?

A CDSCO Loan License is an agreement that allows an individual or entity without a production facility to manufacture medical devices using another company's facilities and infrastructure. This arrangement is made with the mutual consent of both parties and is granted by the licensing authority.

Essential Forms for CDSCO Medical Device Loan License

To apply for a CDSCO Loan License for Medical Devices, certain forms are essential. These forms must be completed accurately to comply with regulatory requirements.

S No.	Description	Application Form	Approval Form	Fees	Licensing Authority
1	Loan License for Class A or Class B medical device	MD-4	MD-6	₹5000 - registration of one plant/site ₹500 for registration of one product	State Licensing Authority
2	Loan license to manufacture Class C or Class D medical device	MD-8	MD-10	₹50,000 - registration of one plant/site ₹1000 for registration of one product	Central Licensing Authority
3	Loan license retention fee for Class A, Class B, Class C, Class D medical device	N/A	MD-9 and MD-10	The retention fee is the same as above, however, this must be paid every 5 years	State Licensing Authority and Central Licensing Authority

Process for Obtaining a CDSCO Medical Device Loan License

Online Registration: Visit the official CDSCO website and access the 'SUGAM CDSCO Portal.' Click on the 'SIGN UP HERE' option to start your application.
Draft Your Application: Prepare an application requesting a Loan License for Medical Devices, tailored to your specific needs.
Submit Documents: Provide all required documents for verification as part of the Loan License application process.
Application Submission :Finalize your application by submitting the completed details and documents. The concerned authority will review and verify your submission before granting the Loan License.

Required Documents for CDSCO Loan License

The following documents are necessary for the CDSCO Loan License process:

Cover Letter
Challan TR6
All Applicable Statutory Forms
Required Fees of applicable Statutory Forms
A Notary with the name, address, and other necessary details of the required personnel involved in daily affairs of the Company along with the respective conduct of business with a photograph needs to be attested
Proof of Residential Address (Ration Card/Passport/Aadhaar Card)
A Consent Letter is a document that details the available facilities and existing licenses held by a company. It should outline all drug categories covered and specify the number of CDSCO Loan Licenses already issued to the company.
Declaration of Technical Personnel involved in the production process, including their roles and expertise, for analysis and assessment.

Conclusion

A Loan License is essential for individuals or entities lacking their own production facilities but seeking to manufacture or distribute medical devices using existing infrastructure. As outlined in the Medical Device Rules, 2017, manufacturers can apply for a Loan License to facilitate the production and distribution of medical devices through the online medical devices portal.

Frequently asked questions (FAQ)

What is CDSCO?

CDSCO, or the Central Drugs Standard Control Organisation, is India's national regulatory authority responsible for overseeing the regulation of drugs, medical devices, and cosmetics.

What is a Medical Device Loan License?

A Medical Device Loan License is a formal agreement that allows two parties to collaborate, where one party provides its facilities and infrastructure for the production and manufacturing of medical devices. This arrangement facilitates the use of another’s resources to create the final product.

Where to Apply for a Medical Device Loan License?

To apply for a Medical Device Loan License, visit the official CDSCO website and submit your application through the SUGAM portal.

Which Licensing Authorities are Under CDSCO?

The two main licensing authorities under CDSCO are: 1)SLA (State Licensing Authority). 2)CLA (Central Licensing Authority)

CDSCO Loan License for Medical Devices