Required Documents for Class C - D Medical Device Manufacturing License Approval

Device master file, site master file, and quality management system documents are necessary for getting manufacturing permission for Class C and D Medical Device.

Summary

• The applicant can submit their application via Form MD-7

• Essential documents during the application process include the device master file, site master file, and quality management system documents

• CDSCO grants license after reviewing Form MD-7 and conducting an inspection

Medical Device Manufacturing License Approval

The Central Drugs Standard Control Organisation (CDSCO) supervises the manufacturing of notified medical devices in India. This regulatory body handles granting licenses and approval of the manufacturing of medical devices.

The manufacturer must apply for the Grant of License to sell and distribute Class C and D Medical devices. As per the Medical Devices Rules (MDR), 2017 provisions, CDSCO grants license approval for manufacturing Class C or D Medical devices in Form MD-9. 

For obtaining manufacturing permission, device master file, site master file, and quality management system documents are necessary.

Forms required for medical device manufacturing permission

Two forms are essential for availing the manufacturing approval of medical devices. The forms are as follows:

• Form MD-7: The application form required to be submitted for a manufacturing license

• Form MD-9: The License obtained for the manufacturing of Class C or D Medical device

Eligibility and the process of application for medical device manufacturing

Any individual who wishes to manufacture Class C and D Medical Devices can apply to the Central Licensing Authority via Form MD-7. In addition, the applicant can submit the application forms via an online portal of the Central Government.

The documents mandatory during the application process are listed in table 1. The applicant must prepare the technical documents carefully per the latest MDR guidelines. Failure to do so may cause postponement in submission or other problems. 

Required Documents For Medical Device Manufacturing License Approval

Table 1: Documents required while applying via Form MD-7 

The government charges for one Class C or D manufacturing device is 50000 INR, whereas the cost for each distinct medical device is 1000 INR.

Inspection for issuing Form MD-9 license

After the individual submits Form MD-7, CDSCO will review the application. This can be followed by an inspection of the manufacturing site, which is done by Medical Device Officers or a Notified body. 

The inspection will be conducted within 60 days from the date of application. An expert may or may not accompany Medical Device Officers or a Notified body during the examination. 

Based on the results obtained during the inspection, CDSCO may grant the license in Form MD-9. The license is granted within 45 days after receiving the inspection report.

Validity of the License

The Form MD-9 license does not have a fixed time for expiry. This license can be valid forever; however, as per the Second Schedule, the license retention fee must be paid promptly within five years of the issue date. 

If the license holder does not make timely payments, the license will get cancelled or suspended.