What is the Meaning of FORM MD-7 and FORM MD-9?

Form MD-7 and Form MD-9
Karan Singh
| Updated: Nov 02, 2022 | Category: CDSCO

A person or a company involved in the manufacturing of Medical Devices in India can distribute/communicate the products by applying through the concerned Authority. The application process includes applying for a Loan, grant, or License to distribute or sell the devices in India. Under Medical Devices Rules, 2017, a Manufacturing License to Manufacture Class C & D Medical Devices is granted in Form MD-9. These Manufacturing License applications are filed in Form MD-7 and used to get the Licenses in Form MD-9. To get a Manufacturing License to Manufacture Class C & D Medical Devices in India, the manufacturer must apply to the concerned Authority. In this blog, we will discuss the meaning of Form MD-7 and Form MD-9.

What is the Purpose of Form MD-7 and Form MD-9?

  1. Form MD-7: This is the application for the grant of a Manufacturing License to distribute or sell Class C and Class D Medical Devices in India.
  2. Form MD-9: This is the Manufacturing License to manufacture for distribution or sale of Class C and Class D Medical Devices in India.

CDSCO Risk-based Classification of Medical Devices in India

Medical Devices in India have usually based on risks; the risk-based classification of Medical Devices in India depends upon their intended use & purpose. The following is the risk-based classification of Medical Devices in India:

Class Risk Medical Devices
Class A Low Risk Surgical dressing, alcohol swabs, absorbent, etc.
Class B Low Moderate Risk BP Monitoring Device, Thermometer, Disinfectants, etc.
Class C Moderate High-Risk Haemodialysis catheter, Implants, etc.
Class D High Risk Heart valve, angiographic guide wire, etc.

In India, Medical Devices are categorised into 4 categories depending upon the indication of risk level and device use. Class A, B, C & D have been set up under the new system, where Class A & Class B Medical Devices present the least risk and Class C or Class D Medical Devices present higher risks to patients.

Checklist for Loan License to Manufacture Class C & D Medical Devices under Form MD-7 and Form MD-9

Following is the checklist for Loan License to Manufacture Class C & D Medical Devices under Form MD-7 and Form MD-9:

  1. Covering Letter;
  2. Constitution of the Firm;
  3. Site Ownership or Establishment or Tenancy Agreement;
  4. Copy of Certificate supporting QMS (Quality Management System) (ISO:13485), if any;
  5. Plant Layout of the premise with an indication of scale;
  6. QMS as per 5th Schedule of MDR, 2017;
  7. Quality Manual and Quality Policy;
  8. Control of Documents and Control of Records;
  9. Management Responsibility;
  10. Internal Audit System;
  11. Preventive & Corrective Action;
  12. Procedure for identifying training needs & make sure that all individuals are trained to adequately perform their assigned responsibilities;
  13. Test License obtained for testing & generation of quality control data;
  14. Undertaking signed stating that the manufacturing site is in compliance with the provision of the 5th Schedule;
  15. Fee challan.

Procedure for Obtaining Loan License to Manufacture Class C & D Medical Devices under Form MD-7 and Form MD-9

Following is the procedure for obtaining Loan License to Manufacture Class C & D Medical Devices under Form MD-7 and Form MD-9:

Step 1: First, the applicant should register with the Ministry of Health & Family Welfare[1].

Step 2: Then, the applicant needs to apply for Loan License for Class C or Class D medical devices in Form MD-7 with all the relevant documents.

Step 3: The forms should be uploaded along with the fee, as mentioned in the 2nd Schedule of Part II.

Step 4: Upload all the relevant information as per sub-rule-(1);

Step 5: After submitting all the vital documents, the CLA will probe the application.

Step 6: Upon approval of the License, the Authority shall provide the License through Form MD-9.

Step 7:Upon rejection of the application, the applicant shall file again to the Authority within 45 days with all the relevant documents.

Validity of the Loan License Received in Form MD-9

The validity of the Loan License received in Form MD-9 is for 5 years. In the case of the License being cancelled/suspended, the applicant shall apply within forty-five days from the date of the action.

Conditions of Manufacturing License to Manufacture Class C or Class D Medical Devices under Form MD-7 and Form MD-9

The following are the conditions for Manufacturing License to Manufacture Class C or Class D Medical Devices under Form MD-7 and Form MD-9:

  1. The License should be produced when requested by the Medical Device Office/any other senior officials from the CLA or SLA;
  2. The License Holder should request approval before making any changes. The request should be applied, as mentioned in the 6th Schedule. After approval, the License Holder shall detail the information within 45 days to the CLA or SLA;
  3. All the audits must be documented;
  4. The License holder should maintain records of manufacturing & and sales should be produced when required by the Medical Officer;
  5. In case the manufacturer of the Medical Device stopped manufacturing the devices for more than 30 days, then the relevant information should be informed to the CLA or SLA;
  6. If any suspected unexpected serious adverse event, the License Holder should inform the CLA or SLA and inform about the action taken within 15 days;
  7. According to sub-rule (3) of Rule 83, the License Holder should perform tests in the lab before releasing the products. All the test documents should be submitted in the SLA or CLA;
  8. All the test samples must be preserved for 180 days after expiry.

Conclusion

In India, the main regulatory body for Medical Devices in India is the CDSCO and its top representative is the DCGI (Drug Controller General of India). The DCGI or Drug Controller General of India is in charge of approving the manufacturing of Medical Devices. Manufacturers & sellers of Medical Devices need to get a CDSCO License. Applications for Manufacturing Licenses to Manufacture Class C & D Devices for sale or distribution should be submitted online using Form MD-7 and Form MD-9 along with a fee.

Read our Article:What is the Purpose of Form MD-3 and Form MD-5?

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Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

 

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