CDSCO License for Foot orthosis

Comprehensive Guide to CDSCO Licensing for Foot Orthosis (Class A Medical Device)

Foot orthoses are essential medical devices designed to provide rigid or semi-rigid correction for orthopedic deformities or injuries of the foot. Classified as a Class A device under the CDSCO framework, these physical support devices require meticulous adherence to regulatory protocols before entering the Indian market. With over 25 years of regulatory consulting experience and having assisted 500+ manufacturers, we provide you with an expert roadmap tailored specifically for Foot Orthosis licensing.

CDSCO Regulatory Framework for Foot Orthosis

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Foot orthoses fall under Class A, the lowest risk category, but still require a thorough regulatory process to ensure safety and efficacy.

The regulatory framework involves:

• Risk-based classification
• Obtaining appropriate manufacturing or import licenses
• Compliance with quality management systems
• Product testing and audits

For detailed classification insights, refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Foot Orthosis

Foot orthosis devices are designated as Class A due to their non-invasive nature and low risk profile. According to the CDSCO guidelines:

• Manufacturing License: MD5 License (Application Form MD3)
• Issuing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

This license mandates compliance with basic quality and safety standards and involves a test license, product testing, documentation, and audit.

Manufacturing License Process (MD5) for Foot Orthosis

1. Apply for Test License (Form MD13): This initial step allows you to manufacture prototypes for testing. Test licenses are typically issued within 1.5 to 2 months.

2. Product Testing: Conduct tests through CDSCO-approved laboratories on parameters such as material safety, durability, and biocompatibility. You can find the list of Testing Laboratories here.

3. Documentation Preparation: Compile essential documents including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) documents.

4. Submit Manufacturing License Application (Form MD3): Submit through the CDSCO MD Online Portal.

5. Audit by Notified Body: Engage an accredited notified body for a mandatory plant audit. Refer to the Notified Bodies List for selecting an auditor.

6. Resolution of Queries: Address any observations raised during audit or by the CDSCO.

7. Grant of MD5 License: Upon satisfactory compliance, the license is issued in Form MD5.

For a detailed walkthrough, our MD5 License Guide is an invaluable resource.

Manufacturing License Documents Required for Foot Orthosis

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing device design and specifications (Guide to DMF)
• Plant Master File (PMF) outlining manufacturing processes (PMF Guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management Best Practices)
• Product Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Foot Orthosis

For importers, the MD15 license granted by the Central Licensing Authority is mandatory before marketing the device in India. The process generally takes 5-6 months.

Key steps include:

• Preparation of comprehensive documentation including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files
• Submission of application on the CDSCO MD Online Portal
• Addressing any queries raised by CDSCO
• Final grant of Import License (Form MD15)

Refer to our Import License Guide for detailed insights.

Import License Documents Required for Foot Orthosis

• Valid Manufacturing License from the country of origin
• Free Sale Certificate affirming market approval abroad
• ISO 13485:2016 certification
• CE Certificate (if marketed in Europe)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

For import licenses (MD15), the total time generally ranges from 5 to 6 months.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Typically included in the above process
• Audit Fees: Vary based on notified body selected

Investing in a robust QMS and documentation upfront can reduce rework and accelerate approvals.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants underestimate the detail required in DMF and PMF. We recommend early preparation using our Device Master File guide.

• Delays in Testing: Selecting a CDSCO-approved lab early expedites product testing. Verify options via the Testing Laboratories list.

• Audit Non-compliance: Proactively prepare for notified body audits by conducting internal audits and gap assessments.

• Query Resolution: Address CDSCO queries promptly with clear, evidence-backed responses.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license acquisitions, our expert team offers tailored consulting services to streamline your Foot Orthosis licensing journey. We assist with document preparation, regulatory strategy, audit readiness, and liaison with CDSCO authorities.

Getting Started with Your CDSCO License Application for Foot Orthosis

1. Assess your device classification and confirm licensing requirements. Foot Orthosis is a Class A device requiring an MD5 license for manufacturing.

2. Prepare and submit the Test License application (Form MD13) via the CDSCO MD Online Portal. Secure early approval to manufacture samples for testing.

3. Arrange product testing at a CDSCO-approved laboratory. Concurrently, begin compiling your detailed Device and Plant Master Files.

4. Engage a Notified Body for your manufacturing site audit. Schedule and prepare documentation as per their checklist.

5. Submit your MD5 manufacturing license application (Form MD3) through the online portal. Ensure all documents are complete to avoid delays.

6. Respond promptly to any CDSCO or Notified Body queries to expedite approval.

7. Upon grant of the MD5 license, commence manufacturing and distribution in compliance with ongoing regulatory obligations.

Embarking on the CDSCO licensing process may seem complex, but with our seasoned regulatory consulting, you can confidently navigate each step. For personalized assistance, reach out to our team and leverage our deep expertise to bring your Foot Orthosis device to the Indian market efficiently and compliantly.