As Per the Medical Devices Rules, 2017, a Loan License to Manufacture Class C & Class D Medical Devices in Form MD-10 is mandatory to manufacture notified medical devices in India. These loan license applications are filed in Form MD-8 and to obtain the loan licenses in Form MD-10. To obtain a loan license to manufacture Class C & D medical devices, the manufacturer has to apply to the Central Licensing Authority via an online portal of the Central Government. It will take between 4 to 5 months to complete the procedure. In this article, we will focus on Form MD-8 and Form MD-10.
Classification of Medical Device
| International Classification | Risk Level | examples |
| Class A | Low | Tongue Depressors, Thermometers |
| Class B | Low Moderate | Hypodermic Needles, Suction Equipment |
| Class C | High Moderate | Lung Ventilator, Bone Fixation |
| Class D | High | Heart Valves, Implantable Devices |
Purpose of the Form MD-8 and Form MD-10
- MD-8: Application for issue of loan license to manufacture for distribution or sale of Class C & D medical device.
- MD-10: Loan License to manufacture for distribution or sale of Class C & D medical devices.
Note: The applicant’s manufacturing site needs must comply with the requirements of the Fifth Schedule of the Quality Management System.
An Overview of CDSCO
The CDSCO stand for Central Drugs Standard Control Organisation under the Directorate General of Health Services, the Ministry of Health & Family Welfare, and the Government of India is India’s NRA (National Regulatory Authority). It is headquartered at FDA Bhawan, Kotla road, New Delhi and has six zonal offices, four sub-zonal offices, thirteen port offices & seven labs spread in the country. Under the Drugs & Cosmetics Act, CDSCO is responsible for approval of new drugs, laying down the standards for drugs, the conduct of clinical trials, control over the quality of imported drugs in the country and coordinating the activities of State Drugs Control Organizations by providing expert suggestion with a view of bringing the uniformity in the enforcement of the Drugs & Cosmetics Act.
Documents for Loan License to Manufacture under Form MD-8 and Form MD-10
Following are some vital documents for Loan License to Manufacture of medical devices under Form MD-8 and Form MD-10:
- Covering Letter;
- Application Form;
- Receipt of fees challan;
- Documents of Site ownership or Tenancy agreement;
- Constitution of the firm, including
- MOA & AOA or Partnership deed.
- List all Partners & Directors with complete postal, age & address.
- Declaration of Partners/Proprietor/Directors/Managing Director.
- Device Master file for all products (according to appendix II/ appendix III of the Fourth Schedule);
- Copy of Test License (if applicable);
- Plant Master File (according to appendix I of Part III of the Fourth Schedule)
- Apart from the mandatory information according to appendix I of Part III of the Fourth Schedule, the following are the documents that should also be submitted:
- Declaration of Analytical Chemist.
- Declaration of Manufacturing Chemist.
- Registration from District Industries Centre.
- Documents of education qualification, experience & approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id proof.
- Consent to establish & consent to operate from State Pollution Control Board
- Performance Evaluation Report (if applicable);
- An undertaking in which the manufacturing Site complies with the provisions of Schedule IV.
Procedure to obtain Loan License to Manufacture under Form MD-8 and Form MD-10
Following is the process to obtain Loan License to manufacture class C & D medical devices in India- Form MD-8 and Form MD-10:
Step 1: Sugam Registration of the applicant.
Step 2: Drafting of application.
Step 3: Upload all the documents as per Form MD-8.
Step 4: Processing the compulsory government fee.
Step 5: Applying the online medical device portal.
Validity
The license grant in Form MD-10 will remain valid permanently, for the retention fee specified in Schedule II is paid before completion of five years from the date of grant unless the Central Licensing Authority suspends/cancels the license.
Conclusion
The Drug Controller General of India (DCGI)[1] oversees all medical devices as part of the Ministry of Health and Family Welfare’s Central Drugs Standard Control Organization (CDSCO).
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