CDSCO License for Finger orthosis

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

Finger orthoses serve as critical physical support devices designed to encompass the whole or part of the finger, aiding in support, alignment, prevention or correction of deformities and injuries, and enhancing finger function. As a Class A medical device under the CDSCO framework, finger orthoses require specific regulatory compliance to ensure market access in India.

With over 25 years of expertise and having successfully assisted 500+ companies in obtaining CDSCO licenses, we provide you with a detailed roadmap tailored for finger orthosis manufacturers and importers.

CDSCO Regulatory Framework for Finger Orthosis

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Finger orthoses fall under the Physical Support category and are classified as Class A (low risk) devices according to the notified Medical Device Classification.

This classification determines the applicable licensing pathway, documentation, and audit requirements. The key regulatory file for finger orthoses is File No. 29/Misc./03/2020-DC (202), notified on 26.7.2021.

Risk Classification and License Requirements for Finger Orthosis

Being a Class A device, finger orthoses require an MD5 Manufacturing License granted by the State Licensing Authority. The process involves several steps including obtaining a test license, product testing, documentation, audit, and final license grant.

For manufacturers, the MD5 license is mandatory before production and sale in India. Importers will require the MD15 Import License, but this guide focuses on manufacturing licensing.

Manufacturing License Process for Finger Orthosis (MD5 License)

The MD5 license for Class A devices follows a structured timeline and process:

1. Test License (Form MD13) — Apply on the CDSCO MD Online Portal to obtain a test license allowing product testing. This takes approximately 1.5 to 2 months.

2. Product Testing — Get the finger orthosis tested at government-approved testing laboratories. Testing focuses on safety, material biocompatibility, and performance.

3. Documentation Preparation — Compile the required documents such as Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, etc.

4. Application Submission (Form MD3) — Submit the manufacturing license application for MD5 through the CDSCO portal.

5. Audit by Notified Body — The notified body conducts an on-site audit to verify compliance. Check the list of notified bodies to select the auditor.

6. Queries Resolution — Address any observations or queries raised by CDSCO or the notified body.

7. License Grant (Form MD5) — Upon satisfactory review and audit clearance, the license is granted, enabling manufacturing to commence.

This entire process typically requires 3 to 4 months from start to finish.

Manufacturing License Documents Required for Finger Orthosis

To streamline your MD5 license application, prepare the following documents meticulously:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Documents
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) — detailing design, manufacturing process, and specifications. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF) — describing the manufacturing facility and quality controls. Refer to our Plant Master File guide.
• Essential Principles Checklist — compliance with applicable standards
• Risk Management File — hazard analysis and mitigation strategies. Implement best practices with our Risk Management guide.
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU) — compliant with CDSCO labeling requirements
• Quality Management System (QMS) Documents — including SOPs and training records

Accurate and complete documentation significantly reduces delays during audit and review.

Import License Process for Finger Orthosis (MD15 License)

Although this guide primarily targets manufacturers, importers of finger orthoses require an MD15 import license issued by the Central Licensing Authority.

The process involves:

• Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Submission of application using Form MD14 on the CDSCO MD Online Portal
• Resolution of queries and final license grant

The MD15 license process takes approximately 5 to 6 months. For further details, refer to our Import License guide.

Timeline and Processing Duration

Total timeframe: Approximately 3 to 4 months.

Government Fees and Costs

For Class A devices such as finger orthosis, the fees are as follows:

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

These fees are payable online via the CDSCO portal. Budgeting for additional costs such as product testing and audit fees (which vary depending on the notified body) is essential.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing laboratories early and submit all samples with complete documentation to avoid retesting.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and consult experienced regulatory professionals to ensure all required documents are accurate and current.

Challenge 3: Audit Non-compliance Observations

• Solution: Prepare your manufacturing site in advance by implementing a robust Quality Management System and training staff on compliance requirements.

Challenge 4: Communication Gaps with CDSCO

• Solution: Maintain proactive communication through the CDSCO MD Online Portal and promptly respond to queries.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for first-time applicants. With our 25+ years of regulatory consulting experience and a track record of over 500 successful licenses, we provide end-to-end support including:

• Gap analysis and readiness assessment
• Document preparation and review
• Coordination with notified bodies and testing labs
• Query management and audit support

Our expertise ensures your finger orthosis manufacturing license application is robust, compliant, and processed smoothly.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing journey for finger orthosis manufacturing:

1. Register on the CDSCO MD Online Portal.
2. Apply for the Test License (Form MD13) to begin product testing legally.
3. Identify and coordinate with an approved testing laboratory early to schedule product tests.
4. Prepare all required documentation, referencing our detailed guides on Device Master Files, Plant Master Files, and Risk Management.
5. Schedule a notified body audit by selecting from the list of notified bodies.
6. Submit your manufacturing license application (Form MD3) upon successful testing and document readiness.

Starting early and following this structured approach dramatically improves approval timelines and minimizes compliance risks.

For personalized assistance or to discuss your specific finger orthosis project, contact our regulatory consultants today and leverage our proven expertise to enter the Indian market confidently.