Process of Class A Class B Medical Device Manufacturing License

Class A and Class B Medical Device Manufacturing License

Class A Class B Medical Device Manufacturing License

  • The Class A Class B Medical Devices classification is managed or regulated by the CDSCO (central drug standard control organization) in India.
  • The medical device classification follows the “Medical Device Rule,2017” to classify the medical devices based on the associated risk.
  • The medical device market of India is currently among the top 20 medical device markets in the world.
  • CDSCO (Central Drug Standard Control Organization) regulates the rules and regulations for manufacturing medical devices in India. 
  • Medical devices directly influence consumers’ health; thus, the government takes extra precautions to maintain the safety and efficacy of the devices.
  • The state licensing authority handles the applications for manufacturing Class A Class B medical devices manufacturing license. 
  • Form 3: The application to manufacture Class A and B medical devices.
  • Form 5: It is the permission to manufacture Class A and B medical devices.

What is Class A Medical Devices?

Class A Medical Devices are the lowest risk medical products on patients and public health risks. Most of medical devices falls under Medical Device Class A classification.  

What is Class B Medical Devices?

Class B Medical Devices are the lowest to moderate risk medical products on patients and public health risks. Class B classified Medical Device manufacturing license is approved by the State Licensing Authority.

Application Form Approval Form Medical Device Class Fee Licensing Authority
Form MD-3 Form MD-5 Class A – Class B Rs. 5K for one site Rs 500 per product State Licensing Authority

Steps To Get Manufacturing License For Class A Class B Medical Devices

  • Step 1: Fill out the application form MD-3
  • Step 2: Pay the required application fees
  • Step 3: Collate the necessary documents for class A class B medical device manufacturing license. 
  • Step 4: Submit all class A class B medical device manufacturing license documents on portal
  • Step 5: Scrutiny of required class A class B medical device manufacturing license documents 
  • Step 6: Audit Process of class A class B medical device manufacturing license
  • Step 7: class A class B medical device manufacturing license SLA decision

A detailed explanation of the steps to get Medical Device Class A Class B manufacturing license:

Step 1: Fill out the application for Class A Class B  medical devices.

  • Fill the Form MD -3 at

Step 2: Fees payment

  • Applicants can make the fee payment through challan.
  • For the site, fees are Rs: 5k and 500 per product per schedule II.

Step 3: Submit the below technical documents as part II of the fourth schedule.

  • Cover letter
  • Application form
  • Fees challan receipt
  • Firm constitutions such as –
  1. Proof of partnership or association.
  2. Declaration of the partners, owners, and managing directors.
  3. Name list, postal and residential address of all the partners/directors.
  • Site ownership documents/ Rent agreement.
  • Plant master file (according to appendix I of part III of the fourth schedule) along with other documents such as:
  1. Declaration of manufacturing and analytical chemist
  2. Educational qualification, experience letter, approved certificate of proposed manufacturing and analytical chemist, appointment letter, and Id proof documents
  3. District registration center registration
  4. Consent to establish and operate manufacturing site from state pollution control board
  • Individual’s product device master file (according to the fourth schedule’s appendix II and III).
  • Performance evaluation report (if applicable)
    Drivers’ test license (if applicable)
  • Assurance that the manufacturing site complies with the requirements mentioned in the fifth schedule.

Step 4: At the online portal of the Ministry of Health Family Welfare, the applicant can submit all the documents.

Step 5: Scrutiny of documents

  • SLA scrutinizes the documents received within 45 days.
  • If any shortcoming is noticed, the query is raised.
  • Applicants are given time to reply to the queries raised.
  • If the application is OK, send for audit to the notified body.

Step 6: Audit Process

  • In the case of Class B medical devices, within 90 days, notified body audits the manufacturing site.
  • Within 30 days, the notified body sends the audit report to SLA.

Step 7: SLA decision

  • SLA scrutinizes the report and, if it finds it satisfactory, then grants permission in Form MD- 5.
  • If SLA finds some gaps, then denies the permission.

Class A B Medical Device Manufacturing License Validity

  • The license received in form 5 is valid for five years.
  • If the license gets suspended or canceled applicant has the right to apply again within 45 days.

Process Of Manufacturing License Class A / B Medical Devices

  • Manufacturing license Form MD-3 is processed at state FDA and CDSCO headquarters.
  • The nodal officer can view the new application under the new application tab.
  • The nodal officer assigns the application to the reviewing officer, who uploads the inspection report.
  • In case of the previous reviewing officer’s unavailability, the nodal officer can forward the application to another review officer.
  • The nodal officer forwards the application to the notified body.
  • Before notified body uploads the Audit approval report, the application process at Notified body and state FDA runs parallel.
  • Under the “new application” tab reviewing office can review the application.
  • The Review officer generates the note sheet after they review or modify the checklist.
  • The review officer forwards the application to licensing authority, where LA generates the note sheet and approves the application.
  • If there is any shortcoming in the application, the LA raises the query.
  • After the application goes to the review officer, they generate the permission, sign it digitally, and the application status is updated to approved. 


  • Class B medical devices are a low, and moderate risk but need a medical device manufacturing license if manufactured in India. 
  • Thus, MD form 3 is used to obtain the manufacturing license in India, approved by the state licensing authority.

Leave a Comment

Your email address will not be published. Required fields are marked *