CDSCO License for Hand orthosis

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

Hand orthosis, a physical support device intended to encompass the whole or part of the hand to support, align, prevent, or correct deformities or injuries and improve hand function, falls under Class A risk classification as per CDSCO regulations. With over 25 years of experience assisting 500+ companies, we understand the nuances of securing your CDSCO license efficiently and compliantly. This guide walks you through the entire regulatory journey, practical steps, costs, and common challenges specific to hand orthosis devices.

CDSCO Regulatory Framework for Hand Orthosis

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Hand orthosis is categorized under physical support devices notified on 26.07.2021 (File No. 29/Misc./03/2020-DC (202)) and classified as a low-risk Class A device.

Class A devices require adherence to state-level regulatory processes, primarily obtaining the MD5 Manufacturing License from the State Licensing Authority. The regulatory focus is on ensuring product safety, quality, and compliance with Essential Principles and risk management requirements.

Risk Classification and License Requirements for Hand Orthosis

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Application Form: MD3
• Licensing Authority: State Licensing Authority (where manufacturing site is located)
• Typical Timeline: 3 to 4 months (inclusive of test license and audit)

The Medical Device Classification guide is a useful resource for understanding device categorization and applicable licenses.

Manufacturing License Process (MD5) for Hand Orthosis

The MD5 license process for Class A devices, including hand orthosis, is a multi-step procedure:

1. Obtain Test License (Form MD13): Before full manufacturing licensing, obtain a test license to initiate product testing. This typically takes 1.5 to 2 months.
2. Product Testing: Submit your hand orthosis samples to CDSCO-approved government testing laboratories for compliance testing. Refer to the list of Testing Laboratories for authorized facilities.
3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) records.
4. Apply for Manufacturing License (Form MD3): Submit your application via the CDSCO MD Online Portal including all required documents.
5. Audit by Notified Body: The State Licensing Authority arranges an audit by a notified body to inspect your manufacturing facility and QMS. Check the Notified Bodies List for authorized auditors.
6. Respond to Queries: Address any observations or queries raised by the department or auditor promptly.
7. Grant of License (Form MD5): Upon successful review and audit, the manufacturing license is granted.

Manufacturing License Documents Required for Hand Orthosis

To ensure a smooth application process, prepare the following documentation meticulously:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
• Proof of Ownership or Lease of Manufacturing Premises: Title deed or lease agreement.
• Technical Staff Qualification Records: Details and qualifications of key technical personnel.
• Fire NOC and Pollution Control NOC: Certificates from local authorities.
• Device Master File (DMF): Comprehensive device description, manufacturing process, and specifications. Our Device Master File Guide provides detailed insights.
• Plant Master File (PMF): Detailed information on manufacturing facilities and equipment. Learn how to create it effectively in our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with safety and performance standards.
• Risk Management File: Including hazard analysis and mitigation strategies following ISO 14971 principles. Refer to our Risk Management Guide for best practices.
• Test Reports: From CDSCO-approved testing laboratories.
• Labels and Instructions for Use (IFU): Drafts compliant with regulatory labeling requirements.
• Quality Management System (QMS) Documents: Including SOPs, CAPA, training records, etc.

Import License Process (MD15) for Hand Orthosis

If you plan to import hand orthosis into India, an MD15 Import License from the Central Licensing Authority is mandatory.

• Application Form: MD14
• Timeline: Approximately 5 to 6 months
• Documents Required: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license (if applicable), and company constitution documents.

Note that unlike manufacturing licenses, import licenses do not require a test license or audit but require thorough document verification. Our Import License Guide offers detailed support for importers.

Timeline and Processing Duration for Hand Orthosis Licensing

Planning ahead and maintaining clear communication with authorities can prevent unnecessary delays.

Government Fees and Costs for MD5 License (Hand Orthosis)

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product (each variant of hand orthosis counts as a separate product)

Additional costs include testing fees charged by approved laboratories and audit fees payable to the notified body. Budgeting for these expenses upfront ensures smooth financial planning.

Common Challenges and Solutions in Licensing Hand Orthosis

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved testing labs early and schedule sample submission promptly. Maintain communication to track progress.

Challenge 2: Incomplete Documentation

Solution: Use our comprehensive checklists and templates for Device Master File, Plant Master File, and risk management to ensure completeness.

Challenge 3: Audit Non-compliance

Solution: Conduct internal pre-audits to verify QMS and facility readiness. Train staff on audit expectations and regulatory requirements.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to respond quickly and precisely to all queries raised by authorities.

Expert Consultation and Support for Hand Orthosis Licensing

Navigating CDSCO regulations can be complex, especially for first-time manufacturers or importers. With our extensive experience helping over 500 companies, we offer tailored consultancy services including:

• Regulatory strategy development
• Document preparation and review
• Pre-audit readiness assessments
• Liaison with CDSCO and notified bodies
• Post-license compliance support

Partnering with experts minimizes risks, accelerates approvals, and ensures sustained compliance.

Getting Started with Your CDSCO License Application for Hand Orthosis

1. Assess Device Classification: Confirm Class A status for hand orthosis per the Medical Device Classification.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
3. Coordinate Product Testing: Arrange sample submission and testing with CDSCO-approved laboratories.
4. Compile Required Documents: Utilize expert guides for DMF, PMF, risk management, and QMS documentation.
5. Submit MD5 License Application: File Form MD3 on the CDSCO portal once testing is complete and documents are ready.
6. Prepare for Audit: Schedule and prepare for notified body inspection.
7. Respond Promptly to Queries: Address any concerns raised during the review.

Starting early and following a structured approach significantly enhances your chances of timely approval. For detailed assistance, reach out to our consultancy team to guide you through every step.

By adhering to these comprehensive procedures and leveraging our expert insights, manufacturers and importers of hand orthosis devices can confidently navigate the CDSCO licensing pathway and successfully enter the Indian market.