What is Form MD 7 & MD 9, and How To Apply for Class C & D Medical Device Manufacturing Permission?

Medical devices in India are manufactured under the rules and regulations set by the regulatory authority of India, that is, CDSCO.

In India, to manufacture a medical device, one should have a manufacturing license from the CDSCO.

Class C – is a moderate-risk medical device, whereas; Class D – is a high-risk medical device.

Form MD 7: The application to grant a manufacturing license to sell and distribute class C and D medical devices.

Form 9: The permission of manufacturing license to sell and distribute class C and D medical devices.

1.1) Steps to get the manufacturing license in India:

Step 1 – Fill out the Form: 

• Fill the Form MD -7 at cdscomdonline.gov.in

Step 2 – Pay the fees.

• Applicants can pay fees under the head of the account through the government treasury challan.
• For the manufacturing plant, fees are 50k, whereas for the product is 1k per product.

Step 3 –Collect the documents:

• Technical documents as part II of the fourth schedule
  • Cover letter
  • Application form
  • Fees challan receipt
  • Firm constitution details – Partnership details, property declaration, list of partners along with age, and complete postal
  • address
  • Site ownership documents/ agreement of tenants
  • Plant manufacturing details as per appendix I present under the III part of the fourth schedule, along with the declaration of manufacturing chemist, analyst chemist, educational qualification documents, and appointment letter,
  • Each product’s device master file as per appendix II/III of the fourth schedule
  • If applicable, a performance evaluation report
  • Test license copy only if applicable
• Undertaking that site is compiled to the QMS as per the fifth schedule.

Step 4 – Submit all the documents to the online portal of the ministry of health and family welfare.

Step 5 – Scrutiny of application:

• CLA does it  
• It takes approximately 40 days
• Any discrepancy is noted, and a query is raised
• The following action is taken upon the reply given by the applicant.

Step 6 – Audit 

• The audit is conducted in manufacturing units by medical device officers and experts. 
• It takes approx. 60 days to complete 
• If any non – compliance is present can be rectified by the applicant.
• If the audit report is satisfactory, it will be sent for further action.

Step 7 – Decision by CLA

• If CLA is satisfied with the report, then a manufacturing license is granted in Form MD – 9. 
• If CLA is not satisfied with the report, then; it rejects the application within 45 days with the rejection reason.

1.2) License Validity –  

• The validity of Form MD – 9 is for five years.
• If, in any case, the license gets suspended or canceled, then the applicant can apply within 45 days from the action date.            

1.3) Process of manufacturing license:

• Manufacturing license Form MD-7 is processed at zones and CDSCO headquarters
• A nodal officer can see the new application under the new application tab.
• The application is assigned to reviewing officer by the nodal officer who uploads the inspection report.
• If the previous reviewing officer is unavailable, then the Nodal officer can forward the application to another review officer.
• Under the new application file reviewing officer can view the file.
• The review officer generates the note sheet after they view/modify the checklist.
• The application is forwarded to the zonal DDA.
• Zonal DDA again reviews the file and generates the note sheet.
• If the inspection report is uploaded by the nodal officer of their corresponding zone, then the application is forwarded to the HQ DA.
• At DA of HQ, again file is reviewed, and the note sheet is generated and sent to LA/RO/SRO of HQ or NO/DDA of Zone.
• Again, LA reviews the file, generates the note sheet, and then approves the file.

• If the application is incomplete, then LA rejects the application and raises the query.
• At last, the application goes to the last assigned reviewing officer, who generates the permission, signs it digitally, uploads it, and shows the status as approved.     

Summary – 

• Previously, the manufacturers could sell their medical devices without any license, but now the government of India has made the manufacturing license compulsory.
• For classes C and D, the application for a license is audited by the CDSCO independently.
• As per Medical device rule (Amendment) rules 2020, it is mandatory to obtain a manufacturing license before  Sep  2023 for classes C and D.