CDSCO License for Shoulder immobilizer

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

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the nuances involved in medical device registration in India. This guide covers everything manufacturers and importers need to know about securing a CDSCO license for the Shoulder Immobilizer, a Class A medical device designed to temporarily immobilize or limit abduction of the shoulder joint to aid healing.

Understanding the Shoulder Immobilizer and Its Regulatory Importance

The Shoulder Immobilizer plays a crucial role in physical support by stabilizing the shoulder joint post-injury or surgery. Classified as a Class A device under Indian regulations, it is considered low risk but still requires compliance with the CDSCO (Central Drugs Standard Control Organization) guidelines to ensure safety, efficacy, and quality. Compliance is mandatory to legally manufacture or import this device into the Indian market.

CDSCO Regulatory Framework for Shoulder Immobilizer

The CDSCO regulates medical devices based on risk classification. For Class A devices like the Shoulder Immobilizer, the licensing process is handled at the State Licensing Authority level through the MD5 manufacturing license (Form MD3 application). This regulatory pathway ensures that devices meet Indian standards before they reach patients.

Risk Classification and License Requirements for Shoulder Immobilizer

Risk Class: A (Low risk)
License Type: MD5 Manufacturing License
Regulatory Authority: State Licensing Authority
Notification Reference: File No. 29/Misc./03/2020-DC (202) dated 26.07.2021

Class A devices require a simpler but thorough process to assure compliance with essential principles, risk management, and quality systems.

MD5 Manufacturing License Process for Shoulder Immobilizer

Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license to produce samples for testing. This step takes approximately 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved government laboratories to verify compliance with Indian standards. You can refer to the list of testing laboratories authorized for this purpose.
Document Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
License Application (Form MD3): Submit your MD5 license application through the CDSCO MD Online Portal with all supporting documents.
Audit by Notified Body: An audit by a notified body is mandatory. Check the list of notified bodies approved for Class A device audits.
Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly.
Grant of MD5 License: Upon successful audit and documentation review, the license will be issued on Form MD5.

Documents Required for MD5 License Application

For your Shoulder Immobilizer, the following documentation is essential:

Constitution of the company (incorporation certificate, partnership deed, etc.)
Proof of ownership or legal possession of the manufacturing premises
Documents of technical staff (qualification and experience certificates)
Fire NOC and Pollution Control Board NOC
Device Master File detailing design, specifications, and manufacturing process (our detailed Device Master File guide can assist you)
Plant Master File describing the manufacturing facility and quality systems (Plant Master File Guide)
Essential Principles Compliance Checklist
Risk Management File, including hazard analysis and mitigation strategies (Risk Management Resource)
Test Reports from government-approved labs confirming device safety and performance
Product labels and Instructions for Use (IFU)
Quality Management System documents (ISO 13485:2016 certification is highly recommended)

Import License Process (MD15) for Shoulder Immobilizer

If you intend to import the Shoulder Immobilizer into India, you will need an MD15 import license granted by the Central Licensing Authority. This process generally takes 5 to 6 months and requires:

Valid manufacturing license from the country of origin
Free Sale Certificate
ISO 13485:2016 and CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale license in India
Company constitution documents

The application is submitted on the CDSCO MD Online Portal via Form MD14. Government fees vary by device class; for Class A devices, it is approximately $1000 per site and$ 50 per product.

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 to 2 months
Product Testing	3 to 4 weeks
Document Preparation	2 to 3 weeks
MD5 License Application (MD3)	6 to 8 weeks
Audit and Query Resolution	4 to 6 weeks
Total Duration	3 to 4 months

Government Fees and Costs

Test License (MD13): No separate fee beyond application processing
MD5 License Application: ₹5,000 per application + ₹500 per product
Notified Body Audit Fees: Varies, generally ₹50,000 to ₹70,000
Testing Fees: Charged by government labs, approximately ₹20,000 to ₹40,000 depending on tests

Common Challenges and Practical Solutions

Document Completeness: Incomplete or inconsistent documentation leads to delays. Use checklists and consult experts to ensure full compliance.
Testing Delays: Testing at government labs can be time-consuming due to backlog. Plan ahead and consider parallel document preparation.
Audit Non-conformities: Prepare your QMS and facilities rigorously to meet notified body requirements.
Query Resolution: Prompt, detailed responses to CDSCO queries expedite approval.

Expert Consultation and Support

Navigating CDSCO licensing for Class A devices like the Shoulder Immobilizer requires precision and experience. We have successfully guided over 500 companies through this process, offering:

Customized document preparation support
Coordination with notified bodies and testing labs
Query resolution assistance
Training on CDSCO MD Online portal usage

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm that your Shoulder Immobilizer falls under Class A as per CDSCO guidelines (Medical Device Classification).
Prepare Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.
Organize Testing Samples: Coordinate with approved labs for timely sample testing.
Develop Comprehensive Documentation: Utilize our guides on Device Master Files and Plant Master Files.
Submit MD5 License Application: Once test reports are obtained, apply using Form MD3.
Prepare for Audit: Engage with a notified body from the CDSCO list and schedule your audit.

By following these practical steps and leveraging our expertise, you can streamline your CDSCO licensing journey for your Shoulder Immobilizer, ensuring a timely and compliant market entry in India.

For detailed assistance, feel free to reach out to our regulatory experts who specialize in medical device licensing and compliance.

CDSCO License for Shoulder immobilizer

Medical Device Information

Important Notice for Class A Devices

Intended Use