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 cdscomdonline.gov.in.
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 –
- Proof of partnership or association.
- Declaration of the partners, owners, and managing directors.
- 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:
- Declaration of manufacturing and analytical chemist
- Educational qualification, experience letter, approved certificate of proposed manufacturing and analytical chemist, appointment letter, and Id proof documents
- District registration center registration
- 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.