CDSCO License for Canalith repositioning procedure chair, manual

Comprehensive Guide to CDSCO Licensing for Canalith Repositioning Procedure Chair, Manual (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having guided 500+ companies through the CDSCO licensing maze, we understand the challenges and requirements involved in bringing medical devices like the Canalith Repositioning Procedure Chair to the Indian market. This manual physical support device, classified as Class A under CDSCO regulations, is intended primarily for the treatment of balance disorders such as benign paroxysmal positional vertigo (BPPV) caused by displaced canaliths in the inner ear.

Understanding the CDSCO Regulatory Framework for Physical Support Devices

The Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation in India, ensuring patient safety and efficacy. Devices like the Canalith Repositioning Procedure Chair fall under the physical support category with a low-risk classification (Class A). The regulatory pathway for Class A devices is streamlined compared to higher-risk devices but still requires strict adherence to documentation, testing, and licensing protocols.

Risk Classification and License Requirements for Your Device

The Canalith Repositioning Procedure Chair is classified as a Class A medical device according to the CDSCO classification system. This classification dictates that manufacturers must obtain an MD5 manufacturing license, which is granted by the State Licensing Authority. The regulatory notification for this device is File No. 29/Misc./03/2020-DC (202), dated 26.7.2021.

To comply with CDSCO, manufacturers must first secure a test license (Form MD13) before proceeding with the MD5 license application (Form MD3). This ensures the device meets safety and performance standards through government-approved testing laboratories.

Step-by-Step Manufacturing License Process (MD5) for Class A Devices

1. Apply for Test License (Form MD13): Initiate your application via the CDSCO MD Online Portal. The test license allows you to legally manufacture samples for testing purposes. This process typically takes 1.5 to 2 months.

2. Product Testing: Submit your Canalith Repositioning Procedure Chair to government-approved testing laboratories. You can find an updated list of testing laboratories here. Testing ensures compliance with Indian standards and essential principles.

3. Document Preparation: Compile all required documentation, including Device Master File and Plant Master File. For assistance, our Device Master File guide and Plant Master File guide provide practical insights.

4. Submit MD5 License Application (Form MD3): Once testing is successful, submit your application electronically via the CDSCO portal.

5. Audit by Notified Body: A mandatory audit will be conducted by a notified body from the official list of notified bodies to verify compliance with Good Manufacturing Practices (GMP).

6. Query Resolution: Address any queries raised by the CDSCO or notified body promptly to avoid delays.

7. Grant of License: Upon successful audit and document verification, you will receive your MD5 manufacturing license (Form MD5).

Essential Documents Required for MD5 License Application

The following documents must be meticulously prepared and submitted:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File detailing design, specifications, and manufacturing process
• Plant Master File describing the manufacturing facility and quality controls
• Essential Principles Checklist ensuring compliance with safety and performance
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Test Reports from government-approved laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Canalith Repositioning Chairs

While our focus here is on manufacturing licenses, importers must secure an MD15 license from the Central Licensing Authority. This process spans approximately 5 to 6 months and requires documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale licenses.

For detailed guidance, refer to our Import License guide.

Timeline and Processing Duration

Note: Timelines can vary based on document completeness and audit scheduling.

Government Fees and Associated Costs

For Class A devices such as the Canalith Repositioning Procedure Chair, the CDSCO levies the following fees:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs may include testing fees charged by laboratories and fees for notified body audits. Budgeting for these expenses early will facilitate smoother project management.

Common Challenges and Practical Solutions

Challenge: Delayed test license approval or audit scheduling.

Solution: Submit complete and accurate applications with all required documents. Engage with notified bodies early to schedule audits and prepare thoroughly for inspections.

Challenge: Incomplete risk management files or inadequate QMS documentation.

Solution: Develop and maintain comprehensive risk management files following ISO guidelines and implement ISO 13485-based QMS. Our risk management guide can help streamline this process.

Challenge: Misunderstanding classification leading to incorrect license applications.

Solution: Confirm device classification through the official CDSCO classification resource and consult with regulatory experts if uncertain.

Expert Consultation and Support

With decades of experience in CDSCO licensing, we offer tailored consulting services to help you navigate the regulatory landscape for your Canalith Repositioning Procedure Chair. From document preparation to audit coordination and query resolution, our experts ensure your application progresses efficiently.

Getting Started with Your CDSCO License Application

1. Register your company profile on the CDSCO MD Online Portal.
2. Prepare and submit your test license application (Form MD13) for initial approval.
3. Engage a notified body early to understand audit requirements.
4. Compile comprehensive Device and Plant Master Files using our detailed guides.
5. Arrange product testing at government-approved labs.
6. Once test reports are available, prepare and submit the MD5 license application (Form MD3).
7. Respond promptly to any queries and prepare for the audit.

Starting early and maintaining clear communication with regulatory authorities and notified bodies can significantly reduce time-to-market for your device.

By following this expert roadmap, manufacturers and importers can confidently achieve CDSCO compliance for the Canalith Repositioning Procedure Chair, ensuring safe, effective treatment options for balance disorder patients across India.