CDSCO License for External asembled lower limb prosthesis

Introduction to External Assembled Lower Limb Prosthesis and Regulatory Importance

External assembled lower limb prostheses are vital rehabilitation devices designed to replace parts of the lower extremity, such as knee, shank, ankle, and foot assemblies. These preassembled artificial limbs restore mobility and improve quality of life for amputees. Given their medical purpose and patient interaction, regulatory oversight ensures safety, efficacy, and quality compliance before market entry in India.

At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the nuances of navigating CDSCO regulations specifically for Class A medical devices like this prosthesis. Proper licensing not only complies with Indian law but also builds trust with healthcare providers and end-users.

CDSCO Regulatory Framework for External Assembled Lower Limb Prosthesis

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Ministry of Health and Family Welfare. This device falls under the Rehabilitation category and is classified as Class A, per the official notification (File No. 29/Misc./03/2020-DC (160) dated 04.08.2022).

Manufacturers of Class A devices must obtain a manufacturing license known as MD5 License, issued by the State Licensing Authority. The regulatory process ensures compliance with the Medical Device Rules 2017, including quality management systems, testing, and audits.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Form MD3 for application, Form MD5 for license grant)
• Authority: State Licensing Authority

Class A devices require adherence to basic safety and performance standards. However, despite being low risk, the process demands thorough documentation, testing, and audit by a notified body to assure compliance.

Manufacturing License Process (MD5) for External Assembled Lower Limb Prosthesis

1. Test License Application (Form MD13): Initially, apply for a test license allowing sample testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Get your prosthesis tested at government-approved laboratories. See the list of testing laboratories recognized by CDSCO.
3. Document Preparation: Compile all mandatory documents including device specifics, quality management, and risk management files.
4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for site and process audit. Reference the list of notified bodies for selection.
6. Query Resolution: Address any queries or observations from the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon successful review and audit clearance, the MD5 license is granted.

Manufacturing License Documents Required

For this specific device and risk class, the following documents are essential:

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical and responsible personnel
• Fire NOC and Pollution Control Board NOC
• Device Master File specific to the external assembled lower limb prosthesis (Device Master File Guide)
• Plant Master File detailing manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist compliance document
• Risk Management File documenting hazard identification and mitigation (Risk Management)
• Test Reports from government-approved labs
• Product Labeling and Instructions For Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process (MD15) for External Assembled Lower Limb Prosthesis

If you are an importer rather than a manufacturer, an Import License (MD15) is required. This process is managed by the Central Licensing Authority and typically takes 5-6 months.

Key steps include:

• Document preparation including Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485 certification, CE certificate, and other technical files.
• Submission of application (Form MD14) through the CDSCO MD Online Portal.
• Responding to departmental queries.
• Finally, grant of Import License on Form MD15.

More details can be found in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license (where applicable)
• Company Constitution documents

Timeline and Processing Duration

• MD5 License (Manufacturing of Class A device): Approximately 3-4 months in total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 2-4 weeks depending on lab workload
  • Application submission and audit process: 1-1.5 months

• MD15 License (Import License): Roughly 5-6 months

Planning ahead and early preparation of documents can significantly reduce delays.

Government Fees and Costs

• MD5 License:

  • Application fee: INR 5,000 per application
  • Product fee: INR 500 per product

• MD15 Import License Fees (for Class A devices): Approximately USD 1,000 per site and USD 50 per product

Note: These fees are subject to change; always verify the latest fee structure on the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Testing: Testing labs may have backlogs. Plan sample submissions early and choose labs strategically.
• Incomplete Documentation: Missing technical files or improper risk management documentation often cause delays. Use our in-depth guides on Device Master File and Risk Management for comprehensive preparation.
• Audit Non-Compliance: Not meeting audit criteria can result in license rejection. Engage experienced notified bodies from the official list and conduct pre-audit internal checks.
• Query Resolution Delays: Swift and complete responses to CDSCO queries are vital to avoid prolonged processing.

Expert Consultation and Support

Navigating CDSCO licensing for external assembled lower limb prostheses requires meticulous preparation and regulatory insight. Our team has successfully guided over 500 companies through this process, ensuring timely approvals and compliance.

We offer:

• End-to-end document preparation assistance
• Liaison with notified bodies and testing laboratories
• Audit readiness training
• Regulatory strategy consulting tailored to your device and business model

Getting Started with Your CDSCO License Application

1. Assess your product classification: Confirm your device falls under Class A rehabilitation devices.
2. Compile initial documents: Begin with company incorporation, site proof, and technical staff details.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to start the testing process.
4. Select notified body and testing laboratory: Choose from the official lists to ensure compliance.
5. Prepare your Device and Plant Master Files: Use our detailed guides for accuracy.
6. Implement a robust Risk Management System: Document hazards, mitigation, and validation.
7. Submit manufacturing license application (Form MD3): Once testing and document readiness are confirmed.

Early engagement with regulatory experts can streamline this process and avoid costly delays. Contact us to leverage our experience and comprehensive support for your external assembled lower limb prosthesis CDSCO licensing journey.