CDSCO License for Hip/knee continuous passive motion exerciser

Comprehensive Guide to CDSCO Licensing for Hip/Knee Continuous Passive Motion (CPM) Exercisers

As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 companies in obtaining CDSCO licenses across India, we understand the nuances involved in medical device approvals. This guide specifically addresses the regulatory pathway for the Hip/Knee Continuous Passive Motion (CPM) Exerciser—a Class B physical support device powered by mains electricity, commonly used post joint surgery or trauma to aid rehabilitation.

Understanding the Hip/Knee CPM Exerciser and Its Regulatory Importance

The Hip/Knee CPM Exerciser is a therapeutic device designed to provide continuous passive motion to joints, accelerating healing and improving range of motion after surgery or injury. Given its electrical operation and direct patient interface, it is classified as a Class B medical device under CDSCO’s risk classification.

Compliance with CDSCO regulations ensures the device meets quality, safety, and efficacy standards, enabling manufacturers and importers to legally market the device in India. Failure to obtain the appropriate license can result in legal penalties and market access denial.

CDSCO Regulatory Framework for Hip/Knee CPM Exercisers

The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India. For Class B devices like the Hip/Knee CPM Exerciser, licensing is granted by the State Licensing Authority under the MD5 license category.

Key regulatory references include:

• Notification File No. 29/Misc./03/2020-DC (202), dated 26.7.2021
• Medical Device Rules, 2017 (amended)

Manufacturers must submit applications via the CDSCO MD Online Portal, ensuring compliance with all stipulated requirements.

Risk Classification and License Requirements for Class B Devices

According to CDSCO’s classification system, a Hip/Knee CPM Exerciser falls under Class B (low-moderate risk). This classification mandates an MD5 manufacturing license, which is processed by the State Licensing Authority.

The MD5 license process includes:

• Obtaining a Test License (Form MD13)
• Product testing at government-approved labs
• Audit by a notified body
• Submission of technical and quality documents

For more details on device classification, visit our Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Hip/Knee CPM Exercisers

1. Apply for Test License (Form MD13): This preliminary license allows you to manufacture the device for testing purposes. The processing time is approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list.
3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Apply for Manufacturing License (Form MD3): Submit through the CDSCO MD Online Portal for the MD5 license.
5. Audit by Notified Body: Coordinate with a notified body for a mandatory plant and quality system audit. Choose from the list of notified bodies.
6. Respond to Queries: Address any clarifications or observations raised by CDSCO or the notified body promptly.
7. Grant of License (Form MD5): Upon successful review and audit, the MD5 license will be issued.

Manufacturing License Documents Required for Hip/Knee CPM Exercisers

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

• Company Constitution and Incorporation Documents: Proof of legal existence.
• Proof of Ownership or Lease of Manufacturing Premises: Valid property documents.
• Technical Staff Qualifications: Details of qualified personnel involved in manufacturing.
• No Objection Certificates (NOCs): Fire safety and pollution control certificates.
• Device Master File (DMF): Detailed device design and specifications. Explore our Device Master File guide.
• Plant Master File (PMF): Information on manufacturing facilities. Learn more on the Plant Master File guide.
• Essential Principles Checklist: Compliance with medical device essential principles.
• Risk Management File: Demonstration of risk analysis and mitigation strategies. See our Risk Management resource.
• Test Reports: Certified test results from approved labs.
• Labels and Instructions for Use (IFU): Device labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and related procedures.

Import License Process for Hip/Knee CPM Exercisers (MD15)

For importers wishing to bring Hip/Knee CPM Exercisers into India, CDSCO mandates an MD15 import license.

Key steps include:

• Document Preparation: Assemble manufacturing license, Free Sale Certificate, ISO 13485, CE certificate, Device and Plant Master Files, wholesale license, and company incorporation documents.
• Submit Application (Form MD14): File through the CDSCO MD Online Portal.
• Queries Resolution: Respond promptly to any departmental requests.
• Grant of Import License (Form MD15): Upon approval, the license is issued.

The import license process typically takes 5-6 months.

Import License Documents Required

• Manufacturing License of the product
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certificate
• CE certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution and relevant incorporation documents

Timeline and Processing Duration for Hip/Knee CPM Exerciser Licensing

Total Time: Approximately 3 – 4 months for manufacturing license.

Import license (MD15) processing takes about 5 – 6 months.

Government Fees and Costs for MD5 License

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

Additional costs to consider:

• Testing fees at approved laboratories
• Audit fees payable to notified bodies
• Consultant fees if engaging expert support

Common Challenges Faced by Manufacturers and Practical Solutions

• Incomplete Documentation: We recommend early preparation of DMF and PMF, and cross-verification using our detailed guides to avoid delays.
• Delayed Testing: Schedule testing well in advance and select government-approved labs from the official CDSCO list.
• Audit Non-compliance: Conduct pre-audit internal reviews to ensure QMS and plant readiness.
• Query Mismanagement: Maintain a dedicated team for prompt response to CDSCO queries to avoid process bottlenecks.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our consultancy has facilitated over 500 successful license approvals by:

• Offering tailored gap assessments
• Preparing robust technical dossiers
• Coordinating with notified bodies and testing labs
• Providing hands-on assistance with online portal submissions

Engage with us early in your product development cycle to align regulatory strategies seamlessly.

Getting Started with Your CDSCO License Application for Hip/Knee CPM Exerciser

1. Assess device classification and confirm MD5 licensing applicability.
2. Compile and review your technical documentation, including Device and Plant Master Files.
3. Apply for the Test License (MD13) via the CDSCO MD Online Portal.
4. Schedule product testing at CDSCO-approved laboratories.
5. Prepare for notified body audit by reviewing QMS and manufacturing processes.
6. Submit your MD5 manufacturing license application (Form MD3) post successful testing and audit.

Our team is ready to assist you throughout this journey, ensuring timely approvals and market entry for your Hip/Knee CPM Exerciser. Contact us to kickstart your application with confidence.

For detailed guides on similar processes, explore:

• MD5 License Guide
• Device Master File Guide
• Risk Management for Medical Devices

By following this expert roadmap, manufacturers and importers of Hip/Knee CPM Exercisers can achieve CDSCO compliance efficiently and enter the Indian market with confidence.