CDSCO License for Prosthetic and orthotic accessory

Comprehensive Guide to CDSCO Licensing for Prosthetic and Orthotic Accessories (Class A Devices)

Introduction: Understanding Prosthetic and Orthotic Accessories and Their Regulatory Importance

Prosthetic and orthotic accessories are critical rehabilitation devices designed to support, protect, or aid the use of prostheses and orthoses. Examples include pelvic support bands, cast shoes, limb covers, and prosthesis alignment devices. These accessories play an essential role in restoring mobility and improving patient quality of life.

Given their medical significance, regulatory oversight ensures these devices meet safety and performance standards before entering the Indian market. The Central Drugs Standard Control Organization (CDSCO) governs the licensing and approval process, assuring manufacturers and importers that their products comply with Indian health regulations.

CDSCO Regulatory Framework for Prosthetic and Orthotic Accessories

Under the medical device regulations notified on 04.08.2022 (File No. 29/Misc./03/2020-DC (160)), prosthetic and orthotic accessories fall under the rehabilitation category and are classified as Class A medical devices. This classification determines the licensing route, risk mitigation measures, and the regulatory authority responsible for approvals.

Risk Classification and License Requirements for Class A Devices

Class A devices represent low-risk medical devices with minimal potential harm. According to CDSCO, manufacturing licenses for Class A devices require an MD5 license granted by the State Licensing Authority. The application must be submitted on Form MD3 through the CDSCO MD Online Portal.

Manufacturers must first obtain a Test License (Form MD13) before proceeding to full licensing. This step ensures the device undergoes proper testing and evaluation by government-approved laboratories.

Manufacturing License Process (MD5) for Prosthetic and Orthotic Accessories

The MD5 license process for Class A devices involves several key stages:

1. Test License Application (Form MD13): Submit an application to obtain a test license. This allows limited manufacture for testing purposes.
2. Product Testing: Conduct product testing at government-approved labs listed in the Testing Laboratories directory. Testing validates compliance with essential safety and performance parameters.
3. Documentation Preparation: Compile required documents including Device Master File, Plant Master File, risk management files, and quality management system documentation.
4. License Application (Form MD3): Apply for the MD5 manufacturing license on the CDSCO portal.
5. Audit by Notified Body: Coordinate with a notified body from the Notified Bodies List for a compliance audit of manufacturing facilities and processes.
6. Query Resolution: Address any queries raised by the CDSCO or the notified body during reviews.
7. License Grant: Upon successful audit and document verification, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required

Manufacturers must prepare and submit comprehensive documentation, including:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control Board Clearance
• Detailed Device Master File outlining design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File describing manufacturing infrastructure and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File showing hazard identification and mitigation strategies (Risk Management Guide)
• Test Reports from government-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation per ISO 13485 standards

Import License Process (MD15) for Prosthetic and Orthotic Accessories

For importers, the MD15 license is mandatory to legally bring prosthetic and orthotic accessories into India. The process is centralized under CDSCO and includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification
• Application submission on Form MD14 through the CDSCO MD Online Portal
• Review and query resolution by CDSCO officials
• License grant on Form MD15

Note that for Class A devices, government fees are generally lower compared to higher-risk classes.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

For Prosthetic and Orthotic Accessories classified as Class A:

• Test License (Form MD13): Approximately 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab schedules
• MD5 License Application and Audit: 1.5 to 2 months

Total estimated timeline: 3 to 4 months from start to finish for manufacturing license.

Import license (MD15) processing takes approximately 5 to 6 months.

Government Fees and Costs

The fee structure for Class A devices under MD5 license is as follows:

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

Additional costs include:

• Testing fees charged by government-approved laboratories (varies by test complexity)
• Notified body audit fees
• Consultancy fees if engaging external experts

Common Challenges and Practical Solutions

Challenge 1: Delays in document preparation and incomplete applications.

Solution: Utilize comprehensive checklists and templates for Device and Plant Master Files. Our Device Master File guide can help streamline documentation.

Challenge 2: Limited access to notified bodies and testing labs.

Solution: Early coordination with notified bodies listed on the official Notified Bodies List and booking lab slots in advance ensures timely testing and audits.

Challenge 3: Queries raised by CDSCO causing processing delays.

Solution: Proactive preparation of risk management files and compliance evidence reduces back-and-forth communication.

Expert Consultation and Support

With over 25 years of experience and over 500 successful CDSCO license applications, we provide end-to-end support tailored to prosthetic and orthotic accessory manufacturers and importers. Our services include:

• Document preparation and review
• Coordination with testing laboratories and notified bodies
• Application submission and follow-up
• Training on regulatory compliance and QMS implementation

Engaging expert consultants can significantly reduce approval timelines and ensure regulatory compliance.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device as Class A using the Medical Device Classification resource.
2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our detailed guides.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Schedule Testing: Engage with government-approved labs early to plan product testing.
5. Coordinate Audit: Contact notified bodies for the required facility audit.
6. Submit MD5 License Application: Once testing and audit complete, submit Form MD3 through the CDSCO portal.

Following these practical steps sets a clear path toward obtaining your manufacturing license for prosthetic and orthotic accessories, enabling you to confidently enter the Indian medical device market.

For personalized assistance, connect with our expert team to streamline your CDSCO licensing journey.