CDSCO License for Hand/finger splint

Comprehensive Guide to CDSCO Licensing for Hand/Finger Splints (Class A Medical Devices)

As a trusted regulatory consultancy with over 25 years of experience and 500+ successful CDSCO licensing projects, we understand the nuances of bringing medical devices like Hand/Finger Splints to the Indian market. These devices, classified as Class A physical support devices, require a well-structured approach to obtain the mandatory CDSCO manufacturing license (MD5 License). Our detailed guide covers every critical aspect so manufacturers and importers can confidently navigate the regulatory landscape.

Understanding Hand/Finger Splints and Their Regulatory Importance

Hand/Finger Splints play a crucial role in immobilizing injured hands to facilitate healing of digits, metacarpals, and wrist injuries. Given their direct application in patient care, regulatory compliance ensures these devices meet safety, quality, and performance standards mandated by the Central Drugs Standard Control Organization (CDSCO). The notification for this device type is registered under File No. 29/Misc./03/2020-DC (202) dated 26.7.2021, officially categorizing it as a Class A medical device under the Physical Support category.

CDSCO Regulatory Framework for Class A Medical Devices like Hand/Finger Splints

The CDSCO classifies medical devices into four risk categories (A, B, C, D). Hand/Finger Splints fall under Class A, the lowest risk category, which are subject to State Licensing Authority oversight. Compliance requires obtaining an MD5 Manufacturing License under Form MD3, following the Medical Device Rules 2017.

Risk Classification and License Requirements for Hand/Finger Splints

• Device Risk Class: Class A (Low Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Granting Authority: State Licensing Authority
• Notification Date: 26.7.2021

This classification implies a streamlined, yet thorough process involving a test license, product testing from government-approved labs, document submission, and an audit by a notified body.

Step-by-Step Manufacturing License Process (MD5) for Hand/Finger Splints

1. Apply for Test License (Form MD13): Initiate by applying for a test license which permits product testing. This phase typically takes 1.5 to 2 months.
2. Product Testing: Submit the Hand/Finger Splints for testing at CDSCO-recognized laboratories to validate safety and quality. Refer to the Testing Laboratories list for approved facilities.
3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, and QMS documents.
4. Apply for Manufacturing License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body listed at the CDSCO Notified Bodies.
6. Resolve Queries: Respond promptly to any queries raised by the licensing authority or notified body.
7. Grant of MD5 License: Upon successful completion, the State Licensing Authority issues the license on Form MD5.

Essential Documents Required for MD5 License Application

For Hand/Finger Splints, the following documents are mandatory:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design and specifications (Device Master File Guide)
• Plant Master File (PMF) illustrating manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File highlighting hazard analysis and mitigation (Risk Management Guide)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU) compliant with CDSCO requirements
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Hand/Finger Splints

If you intend to import Hand/Finger Splints, an MD15 Import License is mandatory. The process includes:

• Document preparation including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files
• Application submission through the CDSCO MD Online Portal
• Resolution of any departmental queries
• License issuance on Form MD15 by the Central Licensing Authority

The import license process typically takes 5 to 6 months. For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration

Total Time: Approximately 3 to 4 months from initial test license application to final MD5 license grant.

Government Fees and Costs for Hand/Finger Splints MD5 License

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (each variant or SKU of Hand/Finger Splint)

Additional costs may include testing fees charged by laboratories and fees for notified body audits. Budgeting for these will ensure smoother financial planning.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to laboratory backlog. Solution: Schedule testing early and choose laboratories with shorter lead times from the Testing Laboratories list.

Challenge: Incomplete documentation leading to query cycles. Solution: Utilize our comprehensive checklists and templates for Device Master File and Plant Master File preparation to ensure completeness and compliance.

Challenge: Audit non-conformities. Solution: Pre-audit internal checks and training of staff on CDSCO requirements can minimize audit observations.

Challenge: Unfamiliarity with CDSCO MD Online Portal. Solution: We provide hands-on support and walkthroughs to help clients navigate the portal efficiently.

Expert Consultation and Support

With our extensive experience handling over 500 medical device licensing projects, including Class A devices like Hand/Finger Splints, we offer:

• End-to-end application management
• Tailored document preparation assistance
• Liaison with CDSCO and notified bodies
• Training on compliance and audit readiness

Engaging expert consultants accelerates your licensing process and prevents costly errors.

Getting Started with Your CDSCO MD5 License Application for Hand/Finger Splints

1. Verify Device Classification: Confirm your Hand/Finger Splint falls under Class A. For more details, visit our Medical Device Classification resource.
2. Gather Core Documents: Start compiling company constitution, premises proof, technical staff credentials, and NOCs.
3. Prepare Device Master File and Plant Master File: Utilize our expert guides to develop compliant documentation.
4. Apply for Test License on the CDSCO MD Online Portal: Begin your journey by submitting Form MD13.
5. Plan Product Testing: Coordinate with CDSCO-approved labs early to avoid bottlenecks.
6. Schedule Notified Body Audit: Choose an authorized notified body from the Notified Bodies List.
7. Maintain Open Communication: Respond promptly to CDSCO queries to avoid delays.

By following these actionable steps, manufacturers and importers can efficiently gain CDSCO clearance for Hand/Finger Splints, ensuring timely market entry and regulatory compliance.

For personalized assistance and a tailored roadmap for your Hand/Finger Splint CDSCO license, contact our expert team today.