CDSCO License for Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non- implanted electrical components.
Medical Device Information
Intended Use
A upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.
Comprehensive Guide to CDSCO Licensing for Upper Extremity Prostheses with Powered Elbow and Shoulder (Class B Medical Device)
As trusted regulatory consultants with over 25 years of experience and having assisted more than 500 companies in successfully navigating the CDSCO licensing landscape, we understand the complexities involved in bringing advanced medical devices like upper extremity prostheses—including simultaneously powered elbow and/or shoulder components with greater than two powered degrees of freedom—to the Indian market.
This guide provides detailed, actionable insights specific to this Class B rehabilitation device, addressing regulatory frameworks, license processes, timelines, fees, and common challenges.
Understanding the Device and Its Regulatory Importance
The device in focus is an upper extremity prosthesis designed to replace a partially or fully amputated or congenitally absent upper limb. It features a simultaneously powered elbow and/or shoulder mechanism with more than two powered degrees of freedom, controlled via non-implanted electrical components. Given its advanced functionality and medical purpose, it falls under Class B risk classification as per CDSCO guidelines.
Proper regulatory compliance ensures patient safety, device efficacy, and smooth market entry. Moreover, adhering to CDSCO regulations protects manufacturers and importers from legal and commercial pitfalls.
CDSCO Regulatory Framework for Upper Extremity Prostheses (Class B Devices)
In India, medical devices like this prosthesis are regulated by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare. Since the device is a Class B medical device, the licensing authority is the State Licensing Authority, and the applicable license is the MD5 manufacturing license.
The regulatory pathway includes:
- Obtaining a Test License (Form MD13)
- Conducting product testing at government-approved labs
- Preparing comprehensive documentation
- Submitting the MD5 application (Form MD3)
- Undergoing a notified body audit
- Addressing any queries from CDSCO or the notified body
- Receiving the final manufacturing license (Form MD5)
You can initiate and track your application on the CDSCO MD Online Portal.
Risk Classification and License Requirements
This prosthesis is categorized as a Class B medical device due to its moderate risk profile involving electronic components and prosthetic functionality.
| Risk Class | License Type | Licensing Authority | Approximate Processing Time | Government Fees |
|---|---|---|---|---|
| Class B | MD5 (Form MD3) | State Licensing Authority | 3-4 months | Rs 5000 per application + Rs 500 per product |
Manufacturing License Process (MD5)
The manufacturing license process for Class B devices is methodical and requires adherence to timelines and document submission:
Test License Application (Form MD13): Obtain a test license to manufacture prototype devices for testing. This stage typically takes 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved laboratories to verify safety and performance. Refer to the list of testing laboratories for approved sites.
Documentation Preparation: Compile necessary documents such as Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
MD5 License Application (Form MD3): Submit your application through the CDSCO MD Online Portal.
Notified Body Audit: A notified body performs a thorough audit of your manufacturing facility and QMS. Check the list of notified bodies to select an authorized auditor.
Queries Resolution: Address any clarifications or additional information requests from the CDSCO or audit body promptly.
License Grant: Receive the MD5 license, authorizing manufacturing of the specified Class B prosthesis.
Manufacturing License Documents Required
Comprehensive documentation is critical for a smooth approval process. For your upper extremity prosthesis, ensure you have:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification Certificates of Technical and Management Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed specifications, design, and manufacturing procedures (see our Device Master File guide)
- Plant Master File (PMF): Manufacturing environment, equipment, and quality control details (refer to our Plant Master File guide)
- Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
- Risk Management File detailing hazard analysis and mitigation (learn more about Risk Management)
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification highly recommended)
Import License Process (MD15)
For importers aiming to bring this prosthesis into India, the MD15 import license is mandatory. The process is handled by the Central Licensing Authority and includes:
- Preparation of documents including manufacturing license from the country of origin, Free Sale Certificate, and ISO 13485 certification
- Submission of application via Form MD14 on the CDSCO MD Online Portal
- Resolution of queries raised by CDSCO
- License grant in approximately 5-6 months
Note that a test license is not required for import licenses.
Import License Documents Required
Key documents include:
- Valid Manufacturing License of the product from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | Concurrent with testing |
| MD5 License Application | Submission after test reports and audit preparation |
| Notified Body Audit | 1 month |
| Query Resolution | 2 - 3 weeks |
| Final License Grant | 1 - 2 weeks |
Overall, expect a total timeline of around 3 to 4 months for the manufacturing license process.
Government Fees and Costs
- MD5 License: Rs 5000 per application + Rs 500 per product
- Testing Fees: Variable depending on the laboratory (typically Rs 50,000 – Rs 1,00,000)
- Notified Body Audit Fees: Charged separately by the notified body, usually Rs 1,00,000 – Rs 2,00,000
Investing in quality documentation and early engagement with notified bodies can reduce the risk of delays and additional costs.
Common Challenges and Practical Solutions
Challenge: Delays due to incomplete documentation or insufficient risk analysis.
Solution: Early preparation of the Device Master File and Risk Management File with expert consultation ensures completeness and compliance.
Challenge: Difficulty in coordinating product testing and audit scheduling.
Solution: Pre-plan testing timelines aligned with notified body availability; maintain transparent communication with all stakeholders.
Challenge: Addressing queries from CDSCO or notified bodies prolonging approval.
Solution: Assign a dedicated regulatory expert to provide timely, precise responses.
Expert Consultation and Support
Navigating CDSCO licensing for sophisticated devices like powered upper extremity prostheses demands in-depth regulatory knowledge and hands-on experience. Our team specializes in:
- Tailored documentation preparation
- Coordinating test licenses and product testing
- Managing notified body audits
- Liaising with CDSCO officials
Partnering with experienced consultants can streamline your licensing journey and mitigate risks.
Getting Started with Your CDSCO License Application
Assess your Device Classification: Confirm the Class B status using the Medical Device Classification resource.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the portal’s submission and tracking features.
Prepare Test License Application: Begin with Form MD13 to secure your test license.
Engage a Notified Body: Select an appropriate notified body early from the official notified bodies list.
Compile Documentation: Start assembling your Device Master File, Plant Master File, and Risk Management File.
Schedule Product Testing: Coordinate with government-approved laboratories for timely testing.
Plan for Audit: Prepare your manufacturing site and QMS documentation for notified body evaluation.
By following these steps systematically, you can confidently advance your upper extremity prosthesis towards successful licensing and market entry in India.
For detailed assistance and customized support, contact our expert regulatory team to leverage our 25+ years of experience in CDSCO licensing and medical device compliance.
