CDSCO License for Denis Brown splint

Comprehensive Guide to CDSCO Licensing for Denis Brown Splint (Class A Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we have supported more than 500 manufacturers and importers to successfully navigate the CDSCO licensing process. In this guide, we focus on the Denis Brown splint, a Class A rehabilitation medical device designed to immobilize the foot for young children with tibial torsion or club foot. Understanding the regulatory landscape for this device is crucial to ensure timely approval and market access in India.

CDSCO Regulatory Framework for Denis Brown Splint

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. The Denis Brown splint falls under the Class A (low risk) category, which requires compliance with specific licensing and quality standards before manufacturing or importing.

The recently issued notification (File No. 29/Misc./03/2020-DC (160), dated 04.08.2022) reaffirms the regulatory oversight for this device, mandating manufacturers and importers to obtain the appropriate CDSCO license.

Risk Classification and License Requirements

The Denis Brown splint is classified as a Class A medical device, indicating low risk. For manufacturing such devices, an MD5 license is mandatory, issued by the State Licensing Authority. Importers must secure an MD15 license from the Central Licensing Authority.

• Manufacturing License: MD5 (Application Form MD3)
• Import License: MD15 (Application Form MD14)

Manufacturing License Process for Denis Brown Splint (MD5)

The process for obtaining an MD5 license involves several stages spanning approximately 3-4 months:

1. Test License Acquisition (Form MD13): Before applying for an MD5 license, manufacturers must obtain a Test License, valid for 6 months, enabling product testing in government-approved labs.
2. Product Testing: Samples of the Denis Brown splint must be tested at notified laboratories listed by CDSCO to verify compliance with applicable standards. You can find the list of testing laboratories here.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, etc.
4. License Application Submission: Apply for the MD5 license on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: An audit by an authorized notified body (refer to the notified bodies list) will be conducted to verify compliance with quality systems.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon satisfaction of all requirements, the MD5 license is issued on Form MD5.

Manufacturing License Documents Required for Denis Brown Splint

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

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• No Objection Certificates (Fire Safety, Pollution Control)
• Device Master File (design, specifications, manufacturing process) — see our detailed Device Master File guide
• Plant Master File (infrastructure, equipment details) — learn more in our Plant Master File guide
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation measures — guidance available at Risk Management
• Test Reports from CDSCO approved labs
• Labels and Instructions for Use (IFU) complying with CDSCO requirements
• Quality Management System (QMS) documents (e.g., ISO 13485 certificates or equivalent)

Import License Process for Denis Brown Splint (MD15)

If you are an importer, the MD15 license from CDSCO’s Central Licensing Authority is mandatory. The process typically takes 5-6 months and involves:

1. Document Preparation: Assemble relevant documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificates, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.
3. Query Resolution: Address any queries raised by CDSCO promptly.
4. License Grant: Upon clearance, the MD15 import license is issued.

Import License Documents Required

• Valid Manufacturing License of Denis Brown splint from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate, if applicable
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

For MD5 License (Class A device like Denis Brown splint):

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

For MD15 Import License (Class A device):

• Site Fee: $1000 per site
• Product Fee: $50 per product

All fees are payable online through the CDSCO portal during application submission.

Common Challenges and Solutions

• Delayed Testing Reports: Testing in government-approved labs can be time-consuming. Plan sample dispatch well in advance and maintain communication with labs.
• Incomplete Documentation: Missing or inaccurate files frequently delay approvals. Utilize detailed checklists and consult regulatory experts to prepare documents.
• Audit Non-Compliance: Notified body audits can uncover QMS or facility issues. Conduct internal audits prior to official inspections.
• Query Backlogs: Promptly respond to all queries with supporting evidence to avoid processing delays.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and a track record of 500+ successful CDSCO licenses, we provide end-to-end support:

• Gap Analysis for your existing compliance status
• Customized Device and Plant Master File creation
• Coordination with notified bodies and testing labs
• Application preparation and submission
• Audit readiness and post-audit support

Our proactive approach helps manufacturers and importers avoid common pitfalls and accelerates market entry.

Getting Started with Your CDSCO License Application for Denis Brown Splint

1. Register on the CDSCO MD Online Portal.
2. Apply for the Test License (MD13) for your Denis Brown splint.
3. Coordinate with authorized testing laboratories to conduct product testing.
4. Prepare all required documents using our comprehensive guides on Device and Plant Master Files.
5. Schedule and prepare for the notified body audit by assessing your QMS and facility readiness.
6. Submit your MD5 manufacturing license application via the portal and monitor the status diligently.

For importers, initiate document compilation early and submit the MD15 application once all documents are in place.

Embarking on your CDSCO licensing journey with expert guidance ensures compliance excellence and a smooth path to market access for your Denis Brown splint. Reach out to us for personalized assistance tailored to your business needs.