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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.
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.
| 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 |
You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.
The applicant needs to draft an application as per his/her requirement, which is obtaining a Loan License for Medical Device.
The applicant is required to submit the necessary documents for the verification process in order to acquire a Loan License.
Complete the process by submitting the details and documents. Your documents will be verified by the concerned authority before granting the Loan License.
Documents required in the process are as follows:
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.