CDSCO License for Ankle/foot orthosis

Comprehensive CDSCO Licensing Guide for Ankle/Foot Orthosis (Class A Medical Device)

As specialists with over 25 years of experience and having supported more than 500 manufacturers and importers, we understand the unique regulatory landscape for medical devices in India. The Ankle/Foot Orthosis, classified as a Class A medical device under the CDSCO framework, requires a meticulous approach to licensing to ensure compliance and market access.

Introduction: Understanding the Ankle/Foot Orthosis and Its Regulatory Importance

An Ankle/Foot Orthosis is designed to support, align, prevent, or correct orthopedic deformities or injuries of the ankle and foot. Additionally, it aids in offloading pressure to improve blood flow, especially beneficial for diabetic foot ulcers and postsurgical wounds. Given its physical support function and patient safety implications, Indian regulations mandate strict adherence to manufacturing and import controls.

CDSCO Regulatory Framework for Ankle/Foot Orthosis

Under the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO) governs medical device licensing. The Ankle/Foot Orthosis falls under Class A, the lowest risk category. This classification simplifies some regulatory requirements but still necessitates a thorough licensing process, primarily managed by the State Licensing Authority via the MD5 license (Form MD3).

We recommend manufacturers familiarize themselves with the Medical Device Classification to confirm the device group and regulatory implications.

Risk Classification and License Requirements for Class A Devices

Class A devices like the Ankle/Foot Orthosis are considered low risk. As per CDSCO guidelines, manufacturing such devices requires an MD5 license, issued by the State Licensing Authority. This license mandates compliance with Good Manufacturing Practices (GMP), quality management systems, and proper documentation.

Manufacturing License Process for Ankle/Foot Orthosis (MD5 License)

The MD5 license application involves several key stages:

1. Test License (Form MD13): Initially, companies must obtain a test license, allowing product testing in government-approved laboratories. This phase typically takes 1.5 to 2 months.

2. Product Testing: Testing must be carried out at CDSCO-approved labs. You can find the updated list of Testing Laboratories here.

3. Documentation Preparation: Compile essential documents including Device Master File and Plant Master File.

4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: The notified body conducts a GMP audit. Review the list of notified bodies to select an authorized auditor.

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

7. Grant of MD5 License (Form MD5): Once all requirements are met, the license is issued.

Manufacturing License Documents Required

Successful MD5 applications for Ankle/Foot Orthosis require the following documentation:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire NOC & Pollution Control Certificate
• Device Master File (DMF) detailing design, materials, and specifications. Our comprehensive Device Master File guide can aid in preparation.
• Plant Master File (PMF) describing the manufacturing facility and processes. For assistance, refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File aligned with ISO 14971 standards. Learn more about Risk Management.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Import License Process for Ankle/Foot Orthosis (MD15 License)

For importers, the MD15 license issued by the Central Licensing Authority is mandatory. This process generally takes 5 to 6 months and does not require a prior test license.

Steps include:

1. Document preparation including Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
2. Application submission on the CDSCO MD Online Portal.
3. Resolution of any queries raised by the department.
4. Grant of Import License (Form MD15).

Import license fees vary by device class, but for Class A devices, expect approximately $1000 per site and$50 per product.

More detailed guidance is available in our Import License Guide.

Timeline and Processing Duration

• MD5 License (Manufacturing): Approximately 3 to 4 months total, including 1.5 to 2 months for test license and product testing.
• MD15 License (Import): Approximately 5 to 6 months.

Being proactive in document preparation and prompt in addressing queries can significantly reduce processing times.

Government Fees and Costs

For the Ankle/Foot Orthosis (Class A):

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included within the overall timeline, fees are embedded in application costs
• Import License (MD15): Approximately $1000 per site +$50 per product (Central Authority fees)

Budgeting for notified body audits and testing lab charges is also essential—these vary based on scope and laboratory.

Common Challenges and Solutions

• Delayed Test Reports: Choose laboratories with proven turnaround times to avoid bottlenecks.
• Incomplete Documentation: Utilize detailed checklists to prepare comprehensive Device and Plant Master Files.
• Audit Non-Conformities: Engage experienced consultants who can pre-audit your facilities and documents.
• Query Responses Delays: Establish a dedicated regulatory team to ensure rapid and precise replies.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our extensive experience in guiding over 500 clients through the process ensures that your application is robust and compliant. From preparing Device Master Files to coordinating audits and addressing queries, we provide end-to-end support.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s classification as Class A.
2. Prepare Documentation: Begin compiling Company Constitution, Device Master File, Plant Master File, and QMS certificates.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved testing laboratories.
5. Plan for the Notified Body Audit: Select a notified body from the official list and schedule audit dates.
6. Submit MD5 License Application (Form MD3): After successful testing and audit readiness.
7. Respond to Queries Promptly: Maintain open communication with regulatory authorities.

By following this structured approach, you can confidently navigate the regulatory process for your Ankle/Foot Orthosis and enter the Indian market efficiently. For specialized assistance, reach out to our expert team to tailor your regulatory strategy and ensure compliance every step of the way.