CDSCO License for Wrist immobilizer

Comprehensive Guide to CDSCO Licensing for Wrist Immobilizer (Class A Medical Device)

Wrist immobilizers play a crucial role in the therapeutic management of non-displaced fractures, strains, sprains, and muscle injuries by temporarily restricting wrist movement. Categorized under physical support devices and classified as Class A by the Central Drugs Standard Control Organization (CDSCO), these devices require a structured licensing approach to enter the Indian market legally. With over 25 years of experience assisting 500+ companies in navigating CDSCO regulations, we provide a detailed, practical roadmap for manufacturers and importers to secure the necessary approvals efficiently.

CDSCO Regulatory Framework for Wrist Immobilizers

The CDSCO regulates medical devices based on risk classification, intended use, and device category. Wrist immobilizers fall under the Class A category, which is considered low risk. As per the Medical Device Rules, 2017, Class A devices require an MD5 manufacturing license granted by the State Licensing Authority. The licensing process ensures that devices meet safety, efficacy, and quality standards before market entry.

The relevant notification for wrist immobilizers is File No. 29/Misc./03/2020-DC (202), dated 26.7.2021, which officially classifies it under Class A physical support devices.

Risk Classification and License Requirements for Wrist Immobilizer

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Applicable Authority: State Licensing Authority
• License Application Form: MD3 for manufacturing; MD13 for test license

Given this classification, manufacturers must first secure a test license on Form MD13, followed by product testing, documentation, and finally apply for the MD5 license on Form MD3.

Manufacturing License Process for MD5 (Class A Wrist Immobilizer)

The MD5 license process typically spans 3 to 4 months, encompassing the following stages:

1. Test License Application (Form MD13): Initiate by applying for a test license to legally manufacture the wrist immobilizer for testing purposes. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at a CDSCO-approved laboratory. Ensure compliance with essential principles and safety standards.

3. Document Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, and quality management system documents.

4. License Application (Form MD3): Submit the application for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo a mandatory audit by an approved notified body to verify compliance.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and documentation review, the MD5 manufacturing license is granted.

Manufacturing License Documents Required for Wrist Immobilizer

For a smooth application process, prepare the following documents:

• Company Constitution: Memorandum and Articles of Association or partnership deed
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC and Pollution Control NOC: Compliance certificates from relevant authorities
• Device Master File (DMF): Detailed description of the wrist immobilizer design, specifications, and manufacturing process. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Comprehensive overview of the manufacturing facility. Refer to our Plant Master File guide for preparation tips.
• Essential Principles Checklist: Declaration of conformity to CDSCO’s essential principles
• Risk Management File: Documentation of hazard identification, risk analysis, and mitigation strategies aligned with ISO 14971 standards. Learn more about Risk Management.
• Test Reports: Laboratory test certificates confirming compliance
• Labels and Instructions for Use (IFU): Sample labels and user manuals
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15) for Wrist Immobilizer

While your wrist immobilizer is Class A and typically manufactured domestically, importers require an MD15 import license granted by the Central Licensing Authority. The process is more documentation-heavy and takes around 5 to 6 months.

Key steps include:

• Preparation of documents including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and Wholesale license
• Submission of application on the CDSCO MD Online Portal
• Responding to queries
• License grant on Form MD15

For an in-depth walkthrough, our Import License Guide can be invaluable.

Timeline and Processing Duration

Planning your timeline with these milestones helps avoid bottlenecks and delays.

Government Fees and Costs

• Test License (MD13): No separate fee but mandatory step
• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

For example, if you are applying for a wrist immobilizer only, the total government fee would be Rs 5,500.

Additional costs may include audit fees charged by notified bodies and testing fees at accredited laboratories.

Common Challenges and Solutions

• Delayed Documentation Preparation: Start early on compiling key documents such as Device Master File and Risk Management File. Use expert templates.
• Testing Failures: Choose accredited testing labs and pre-validate your product internally before official testing.
• Audit Non-Compliance: Conduct internal audits simulating notified body inspections to identify gaps.
• Query Resolution Delays: Assign a dedicated regulatory professional to handle queries swiftly.

Our experience has shown that proactive planning, thorough documentation, and timely communication with authorities minimize these challenges.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants in the medical device sector. Our team has successfully supported over 500 companies, providing end-to-end assistance from classification to license grant.

We offer:

• Customized gap analysis for your wrist immobilizer
• Document preparation and review services
• Coordination with notified bodies and testing labs
• Complete application filing and follow-up

Reach out to leverage our expertise and reduce your time-to-market.

Getting Started with Your CDSCO License Application for Wrist Immobilizer

1. Assess Device Classification: Confirm Class A status per CDSCO notification dated 26.7.2021.
2. Prepare Test License Application: Gather preliminary documents and apply for the test license (Form MD13) via the CDSCO MD Online Portal.
3. Select Testing Laboratory: Choose a CDSCO-approved lab from the Testing Laboratories list for product evaluation.
4. Compile Required Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and other QMS documents.
5. Schedule Notified Body Audit: Identify and engage an approved notified body for the audit process.
6. Submit MD5 License Application: Apply on the CDSCO portal with all supporting documents.
7. Respond to Queries Promptly: Maintain open communication with licensing authorities.

By following these practical steps and leveraging expert support, you can confidently navigate the CDSCO licensing process for your wrist immobilizer and successfully enter the Indian medical device market.

For detailed assistance, refer to our comprehensive MD5 License Guide.