What is the Meaning of Form MD-8 and Form MD-10?

In India, all medical devices and IVDs are regulated by the DCGI (Drug Controller General of India) within CDSCO, part of the Ministry of Health & Family Welfare. The regulatory framework for medical devices is based on the Medical Device Rules, 2017. As per the MDR, 2017, a Loan License to manufacture Class C & Class D Medical Devices in Form MD-10 is needed to manufacture notified medical devices in India. The application for Loan License is filed in Form MD-8, which is used to get the License in Form MD-10. So, to obtain a Loan License to manufacture Class C & Class D medical Devices, the manufacturer must file the application to CLA or Central Licensing Authority through an online portal of the CDSCO. Scroll down to check more about Form MD-8 and Form MD-10.

Different Classes of Medical Devices in India

In India, there are different classifications for Medical Devices & IVDs; each has 4 different classes based on their risk. Below is the table of different classes of Medical Devices in India:

What is the Purpose of Form MD-8 and Form MD-10?

Following is the purpose of Form MD-8 and Form MD-10:

Conditions for Obtaining Medical Device Loan License in India under Form MD-8 and Form MD-10

Following are various conditions to be followed by the applicant to get Medical Device Loan License under Form MD-8 and Form MD-10:

1. The applicant is required to get his or her License whenever requested by any Medical Device Office or any officer from Central Licensing Authority.
2. As per Rule 83, Sub-Rule (3), the License owner is required to perform various tests in the lab before the products are released and all the test documents are required to be submitted in Central Licensing Authority.
3. In case the manufacturing of a medical device has stopped for more than a month or 30 days, then the manufacturer of the device should inform the same to the CLA.
4. The records of manufacturing & sales should be kept safe by the License holder and are required to be produced to the medical office whenever requested.
5. In case of any unpredicted or suspected incident, the license holder is required to inform the CLA regarding the incident and actions taken for the same within 15 days of the incident.
6. Before making any changes, the license holder must get approval for the same. After getting g approval, the holder is required to submit the details of the changes to the CLA.
7. The manufacturing site of the applicant must comply with the requirements of the 5^th Schedule of the QMS (Quality Management System).
8. Site Master Files and Device Master Files must be prepared as per Medical Device Rules, 2017 format.

Documents Required for Loan License to Manufacture Class C & Class D Devices under Form MD-8 and Form MD-10

Following are some crucial documents required for Loan License to Manufacture Class C & Class D Devices under Form MD-8 and Form MD-10:

• Device Master File;
• Site Master File;
• QMS documents;
• Covering letter;
• Documents of Site Ownership or Tenancy Agreement;
• MOA and AOA;
• List of all directors and partners;
• Copy of test license (if applicable);
• Performance Evaluation Report (if applicable);
• An undertaking in which the manufacturing site or premise complies with the provisions of ScheduleV;
• Constitution of the Firm;
• Plan layout of the premise with the indication of scale;
• Internal Audit System
• Quality Manual & Policy;
• Management responsibility;
• Preventive and Corrective Action;
• Fee Challan
• Copy of duly notarised valid copies of Quality Certificate concerning manufacturing site (if any).

Procedure to Get Loan License to Manufacture Class C & Class D Medical Devices under Form MD-8 and Form MD-10

Following is the procedure to obtain a Loan License to Manufacture Class C & Class D Devices under Form MD-8 and Form MD-10:

Step 1: First, the applicant needs to register at the SUGAM portal.

Step 2: Then, the applicant is required to file Form MD-8 in order to apply for a Loan License for Class C and Class D medical Devices.

Step 3: After that, upload all the documents as per the checklist of Form MD-8.

Step 4: Then, the applicant needs to pay the mandatory Government fee.

Step 5: Submit the application on the online medical device portal^[1].

Step 6: After submitting the application, the application is checked by the concerned Licensing Authority, and then the application is approved in Form MD-10 for Class C & D for Loan Licenses.

Step 7: In case the application is rejected, then the CLA is required to notify the applicant within 45 days in writing.

Validity of Loan License

A Loan License issued in Form MD-10 will remain valid permanently as long as the retention fee as specified in the 2^nd Schedule is paid before completion of 5 years from the date of issue unless the CLA cancels or suspends the License.

Conclusion

Loan License to manufacture Class C and Class D Medical Devices helps to increase the production of existing notified medical devices & achieve new heights in the business.

Read our Article:Top Differences Between Medical Devices and IVDs – An Overview