CDSCO License for Acupuncture kit

Comprehensive CDSCO Licensing Guide for Acupuncture Kits (Class B Medical Device)

Acupuncture kits, classified under Class B medical devices in India, are specialized collections of instruments and supplies designed for pain management through acupuncture procedures. Given their medical application and direct patient contact, regulatory compliance is crucial for manufacturers and importers aiming to enter the Indian market. With over 25 years of experience and having supported 500+ companies, we provide you with an expert walkthrough of the CDSCO licensing process tailored specifically for acupuncture kits.

Understanding the CDSCO Regulatory Framework for Acupuncture Kits

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Post the Medical Devices Rules, 2017, acupuncture kits fall under Class B category, which denotes moderate risk. This classification mandates obtaining a manufacturing license from the State Licensing Authority via the MD5 license pathway. Compliance ensures adherence to safety, quality, and efficacy standards critical for patient safety.

Risk Classification and License Requirements for Acupuncture Kits

• Risk Class: B (Moderate Risk)
• License Required: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority
• Regulatory Notification: File No. 29/Misc./03/2020-DC (178), dated 13.9.2021

Class B devices like acupuncture kits require a test license before full manufacturing approval, followed by product testing, documentation, audit, and license issuance.

Step-by-Step Manufacturing License Process (MD5 License)

1. Obtain Test License (Form MD13): Initiate with a test license application to produce prototypes/samples for testing. Processing time is approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at government-approved laboratories. Refer to the list of testing laboratories authorized by CDSCO.
3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management file, and Essential Principles Checklist.
4. Apply for MD5 License (Form MD3): Submit your application via the CDSCO MD Online Portal to the state licensing authority.
5. Audit by Notified Body: A notified body audit is mandatory for Class B devices. Check the list of notified bodies to select your auditor.
6. Resolve Queries: Address any departmental or audit queries promptly.
7. License Grant: Upon successful audit and document verification, the MD5 license is granted.

For a detailed stepwise guide, our MD5 License Guide offers invaluable insights.

Essential Documents for MD5 Manufacturing License Application

When applying for the MD5 license for your acupuncture kit, ensure you have the following documentation:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File detailing design, specifications, and manufacturing process (see our Device Master File guide)
• Plant Master File describing facilities and quality systems (Plant Master File guide)
• Essential Principles Checklist aligning with Indian Medical Device Rules
• Risk Management File demonstrating hazard identification and mitigation (Risk Management resource)
• Test Reports from government-approved labs for safety and performance
• Labels and Instructions for Use (IFU) compliant with CDSCO standards
• Quality Management System Documents, typically ISO 13485:2016 certification

Import Licensing Process (MD15) for Acupuncture Kits

For importers, CDSCO mandates the MD15 license issued by the Central Licensing Authority. The key steps include:

• Preparation of required import documents such as Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and manufacturing license from the country of origin
• Submission of Form MD14 application through the CDSCO MD Online Portal
• Resolution of any CDSCO queries
• License issuance typically within 5-6 months

For a detailed process, refer to our Import License Guide.

Typical Timeline and Processing Duration for MD5 License

Government Fees and Cost Breakdown

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (each variant of the acupuncture kit)

Additional costs to budget for include:

• Testing laboratory fees (varies by test scope and lab)
• Notified body audit fees (based on notified body selected)
• Consultancy or expert support fees if engaging external assistance

Common Challenges and Practical Solutions

• Incomplete Documentation: Incomplete or inconsistent documentation is a leading cause of delays. Utilize detailed checklists and expert review to ensure completeness.
• Testing Delays: Government labs can have long turnaround times. Plan testing early and consider multiple approved labs.
• Audit Scheduling Conflicts: Coordinate early with notified bodies to secure audit dates.
• Regulatory Updates: Stay updated on changing regulations and notifications, such as the latest Class B device amendments.

Our extensive experience in navigating these challenges helps clients avoid pitfalls and expedites approvals.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, particularly for Class B devices like acupuncture kits. Our team has supported over 500 companies through successful licensing by providing:

• End-to-end application preparation
• Device and Plant Master File development
• Risk management and Essential Principles compliance
• Liaison with notified bodies and CDSCO officials
• Timely query resolution and follow-up

Partnering with experienced consultants can significantly reduce approval times and ensure regulatory compliance.

Getting Started with Your CDSCO License Application for Acupuncture Kits

1. Assess Your Device Classification: Confirm your device's Class B status as per CDSCO guidelines. Use resources like the Medical Device Classification tool.
2. Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO MD Online Portal.
3. Schedule Product Testing: Book testing slots at notified government laboratories.
4. Prepare Required Documentation: Begin assembling your Device Master File, Plant Master File, and Risk Management File.
5. Engage a Notified Body: Select and coordinate with a notified body for the mandatory audit.
6. Submit MD5 Application: Complete and submit Form MD3 with all supporting documents.
7. Monitor and Respond to Queries: Track your application status and promptly address any departmental or audit queries.

By following these targeted steps and leveraging expert support, manufacturers and importers can successfully secure CDSCO approval for acupuncture kits, unlocking access to the growing Indian medical device market.

For personalized assistance and detailed guidance, contact our regulatory consultancy team experienced in CDSCO medical device licensing.