CDSCO (INDIA)
Documents needed for a Loan License for Medical Devices - Process, Fees, Benefits
Updated on July 06, 2024 06:08:52 PM
The Central Drugs Standard Control Organisation is the National Regulatory Authority of India, being the highly powerful organization in India. It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning. CDSCO is responsible for the approval of new drugs and granting of licenses under the Drugs and Cosmetics Rules, 1945.
What is a CDSCO Loan License for Medical Devices?
CDSCO Loan License is an agreement between two Individuals who have been granted the rights by the licensing authority to the applicant who does not have a production facility or any other arrangements for production but can use other’s facilities and infrastructure for manufacturing the device with the mutual consent of Individuals involved.
What are Important Forms for CDSCO Loan License for Medical Devices?
| 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 CDSCO Medical Device Loan License
The process of acquiring a CDSCO Medical Device Loan License can be understood as follows: :
Signing Up
Drafting an Application
Document Submission
Submission of the applicationStep 1 : Signing Up
You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.
Step 2 : Drafting an Application
The applicant needs to draft an application as per his/her requirement, which is obtaining a Loan License for Medical Device.
Step 3 : Document Submission
The applicant is required to submit the necessary documents for the verification process in order to acquire a Loan License.
Step 4 : Submission of the application
Complete the process by submitting the details and documents. Your documents will be verified by the concerned authority before granting the Loan License.
CDSCO Fee for Product
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Cokion.
What Documents are required in the CDSCO Loan License process?
Documents required in the process are as follows:
- Cover Letter
- TR6 Challan
- 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 (declaring all the available facilities and the license details in possession that indicates all the categories of drugs and the number of CDSCO Loan License already issued for the Company)
- Declaration of the technical personnel involved in the production process for analysis
Conclusion
Individuals must apply for a Loan license if they do not have their own Production facilities and wants to use other brands Or if they want to sell or distribute medical devices through the online system of the medical devices portal. As Medical device rules 2017 stated a provision for manufacturers to apply for a medical device loan license.
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Frequently Asked Questions
CDSCO stands for Central Drugs Standard Control Organisation.
A Medical Device Loan License is an agreement between two individuals who shares their owned facilities for the production and manufacturing of the final product.
Applications can be registered at the official website of CDSCO on ‘SUGAM’ portal.
SLA-State Licensing Authority and CLA-Central Licensing Authority.