CDSCO License for Power Knee

Comprehensive CDSCO Licensing Guide for Power Knee – Class B Rehabilitation Device

As a trusted regulatory consultant with over 25 years of experience and having assisted 500+ companies, we understand the critical role of securing the right CDSCO license for medical devices like the Power Knee. This motor-powered microprocessor knee joint is a Class B rehabilitation device designed to enhance mobility for amputees, and its entry into the Indian market mandates a thorough, compliant licensing process.

Understanding the Power Knee and Its Regulatory Importance

The Power Knee provides active assistance during walking, stair navigation, and standing activities, making it a sophisticated Class B medical device requiring state-level manufacturing licensing. Given its intended use in critical rehabilitation, regulatory authorities scrutinize its safety, quality, and performance rigorously.

CDSCO Regulatory Framework for Class B Rehabilitation Devices

India’s Central Drugs Standard Control Organization (CDSCO) governs medical device approvals under the Medical Device Rules, 2017. The Power Knee falls under Class B (low-moderate risk), which requires obtaining the MD5 manufacturing license from the State Licensing Authority.

Compliance with essential principles, technical documentation, and quality management systems is mandatory to demonstrate device safety and efficacy.

Risk Classification and License Requirements for Power Knee

• Risk Class: B (Low to moderate risk)
• License Required: MD5 Manufacturing License (Form MD3) from the State Authority
• Process Includes: Test license (MD13), product testing, audit by notified body, and final licensing

For detailed classification criteria, consult the Medical Device Classification guide.

Manufacturing License Process (MD5) for Power Knee

1. Test License Application (Form MD13): Apply for a test license to manufacture samples for testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories.
3. Document Preparation: Compile the Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.
4. License Application (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo audit by a CDSCO-recognized notified body. You can check the list of notified bodies to choose one.
6. Query Resolution: Address any queries raised during audit or review.
7. Grant of License: Upon satisfactory compliance, the license on Form MD5 is issued.

Manufacturing License Documents Required for Power Knee

• Company Constitution and Incorporation Certificate
• Proof of Premises Ownership or Lease
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Comprehensive documentation covering design, specifications, and manufacturing process. Our detailed Device Master File guide can help.
• Plant Master File (PMF): Details of manufacturing facility and quality control processes. See our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation per ISO 14971 standards. Learn more about Risk Management.
• Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Power Knee

If importing the Power Knee, the MD15 import license is mandatory, granted by the Central Licensing Authority. The process takes approximately 5-6 months and requires comprehensive documentation including manufacturing license, Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files, and wholesale license.

Full details on import licensing are available in our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Testing: Depends on lab capacity, typically 1 month
• Document Preparation: Concurrent with testing, 1 to 2 months
• Audit and Application Processing: 1 to 1.5 months
• Total Timeline: Approximately 3 to 4 months from application to license grant

Government Fees and Costs

• Application Fee: ₹5,000 per MD5 license application
• Per Product Fee: ₹500 per product variant (Power Knee variants if applicable)
• Notified Body Audit Fees: Vary by notified body, typically ₹50,000 to ₹1,00,000
• Testing Charges: Variable depending on test scope and lab

Common Challenges and Solutions

Challenge: Delays in document preparation and incomplete risk management files

Solution: Engage regulatory experts early to develop compliant Device and Plant Master Files, and implement ISO-compliant risk management practices

Challenge: Selecting an appropriate notified body for audit

Solution: Refer to the official notified bodies list and choose one experienced with Class B rehabilitation devices

Challenge: Extended query resolution timelines

Solution: Maintain open communication with CDSCO officers and promptly provide clarifications with supporting documentation

Expert Consultation and Support

With our extensive experience guiding over 500 companies through CDSCO licensing, we provide end-to-end support—from documentation, test license acquisition, product testing coordination, to audit preparation and query handling. Our tailored approach ensures you meet all regulatory requirements efficiently.

Getting Started with Your CDSCO License Application for Power Knee

1. Assess Classification: Confirm your device’s Class B status using official guidelines
2. Prepare Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management File
3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to begin testing
4. Schedule Testing: Coordinate with CDSCO-approved labs early to avoid bottlenecks
5. Engage Notified Body: Select and schedule your audit with an appropriate notified body
6. Submit MD5 Application: Once testing and audit are complete, apply using Form MD3
7. Respond Promptly: Address any queries from CDSCO to prevent delays

Embarking on the CDSCO licensing journey for the Power Knee requires meticulous preparation and strategic planning. Partnering with an expert regulatory consultancy can dramatically smoothen this process, ensuring faster market entry and compliance assurance.

For personalized assistance, detailed checklists, and ongoing support, contact us to leverage our 25+ years of regulatory excellence in India's medical device sector.