CDSCO License for Acupuncture point  detector

Introduction to Acupuncture Point Detector and Regulatory Importance

The Acupuncture Point Detector is an innovative electronic probe designed to accurately identify acupuncture points on a patient’s body, facilitating precise pain management therapies. Classified under Class B medical devices by the Central Drugs Standard Control Organization (CDSCO), this device demands strict regulatory compliance to ensure safety, efficacy, and quality before entering the Indian market. Understanding and navigating the CDSCO licensing landscape is crucial for manufacturers and importers aiming for timely market access.

With over 25 years of regulatory consultancy experience and having supported 500+ companies in obtaining CDSCO licenses, we provide a detailed roadmap tailored specifically for the Acupuncture Point Detector under its notified category (File No. 29/Misc./03/2020-DC (178), dated 13.9.2021).

CDSCO Regulatory Framework for Acupuncture Point Detectors

The CDSCO classifies medical devices based on associated risks. The Acupuncture Point Detector falls under Class B, which is considered moderate risk. This classification mandates compliance with the MD5 manufacturing license process regulated by State Licensing Authorities. The regulatory framework ensures the device meets the Essential Principles of safety and performance as outlined in the Indian Medical Device Rules 2017.

Manufacturers must secure a Test License (Form MD13) initially, followed by product testing from government-approved labs, and then proceed to apply for the manufacturing license (MD5) using Form MD3. All licensing procedures are managed via the CDSCO MD Online Portal.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Acupuncture Point Detector require:

• Test License (Form MD13): To conduct necessary product testing.
• Manufacturing License (Form MD3 for MD5 license): To legally manufacture the device within India.
• Audit by Notified Body: To verify compliance with QMS and regulatory requirements. You can refer to the list of notified bodies authorized to conduct audits.

Manufacturers should be aware that Class B devices fall under the purview of the State Licensing Authority, making the process slightly faster and less costly compared to higher-risk classes.

Manufacturing License Process (MD5) for Acupuncture Point Detectors

The MD5 license process for Class B devices involves the following steps:

1. Apply for Test License (Form MD13): Submit application on CDSCO portal; this approval takes approximately 1.5 to 2 months.
2. Product Testing: Conduct tests at government-approved laboratories. Refer to the list of CDSCO testing laboratories.
3. Document Preparation: Compile comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documentation.
4. Application for Manufacturing License (Form MD3): Submit via CDSCO MD Online Portal.
5. Audit by Notified Body: An audit will be conducted to verify compliance.
6. Query Resolution: Address any queries raised by CDSCO or the notified body.
7. Grant of MD5 License: Upon successful review and audit, the State Licensing Authority issues the manufacturing license.

The entire process typically takes 3 to 4 months from test license application to license grant.

Manufacturing License Documents Required for Acupuncture Point Detectors

To ensure a smooth application process, prepare the following documents:

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical staff qualifications and experience records
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing processes; for guidance, see our Device Master File guide
• Plant Master File (PMF) describing the manufacturing facility; learn more in our Plant Master File guide
• Essential Principles Checklist confirming compliance with safety norms
• Risk Management File documenting risk analysis and mitigation strategies; refer to Risk Management guidance
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certification recommended)

Import License Process (MD15) - Applicable if Importing

While our focus is on manufacturing, importers of the Acupuncture Point Detector must acquire an MD15 import license granted by the Central Licensing Authority. The process involves:

• Preparing documents such as Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and device-related master files.
• Submission of Form MD14 application on the CDSCO MD Online Portal.
• Resolving any queries raised by CDSCO.
• License issuance within approximately 5-6 months.

For detailed guidance, consult our Import License guide.

Import License Documents Required

• Valid Manufacturing License of the overseas manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license of the Indian importer
• Company Constitution documents

Timeline and Processing Duration for MD5 License

Overall, expect the MD5 license acquisition to take approximately 3 to 4 months.

Government Fees and Costs

The fee structure for MD5 licensing of Class B devices is as follows:

• Application fee: INR 5,000 per application
• Product fee: INR 500 per product

Additional costs include laboratory testing fees (varies by lab), notified body audit charges, and costs for preparing documentation and QMS implementation.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Ensure all test license documents are accurate and complete before submission, and follow up regularly via the CDSCO MD Online Portal.

Challenge 2: Difficulty Obtaining Test Reports from Approved Labs

• Solution: Engage with CDSCO-recognized labs early; refer to the updated Testing Laboratories list.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits and gap assessments prior to notified body visits. Maintain robust QMS and device records.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with detailed, evidence-backed answers. Maintain clear communication with CDSCO officers.

Expert Consultation and Support

Given the complexity of the CDSCO regulatory framework, expert consultation can significantly reduce time to market and avoid costly errors. Our extensive experience with over 500 successful licensing projects, including for Class B devices like the Acupuncture Point Detector, enables us to offer:

• Pre-application regulatory assessments
• Comprehensive document preparation assistance
• Coordination with notified bodies and testing labs
• Post-license compliance support

Getting Started with Your CDSCO License Application for Acupuncture Point Detector

To initiate your licensing journey:

1. Register your organization on the CDSCO MD Online Portal.
2. Prepare and submit your Test License application (Form MD13) along with required documents.
3. Schedule product testing with a CDSCO-approved lab.
4. Collect and organize all technical documentation, including Device Master File and Risk Management File.
5. Once test reports are available, submit your manufacturing license application (Form MD3) for the MD5 license.
6. Arrange for notified body audit and prepare to address any observations.

By following these actionable steps and leveraging expert support, manufacturers can achieve a smooth and efficient licensing process, enabling timely launch of Acupuncture Point Detectors in the Indian healthcare market.

For more detailed insights, explore our comprehensive MD5 License Guide and reach out to our regulatory experts for personalized assistance.