CDSCO License for Parapodium walking frame

Understanding the Parapodium Walking Frame and Its Regulatory Importance

The Parapodium walking frame is a vital physical support medical device designed to assist patients who cannot stand unassisted. By providing body support and altering the center of gravity (COG), it enables improved mobility and independence. Given its role in patient safety and mobility, stringent regulatory compliance is essential before marketing or manufacturing this device in India.

With the CDSCO notification (File No. 29/Misc./03/2020-DC (202), dated 26.7.2021), the Parapodium walking frame is classified under Class A medical devices—designated for low risk but still requiring proper adherence to regulatory frameworks to ensure safety and efficacy.

CDSCO Regulatory Framework for Parapodium Walking Frame (Class A)

India’s Central Drugs Standard Control Organization (CDSCO) governs medical device regulation through a risk-based classification system. Class A devices like the Parapodium walking frame are considered low risk but require mandatory licensing via a State Licensing Authority. The applicable license for manufacturing is the MD5 license (issued on Form MD3), while importers need the MD15 license.

This regulatory framework ensures that devices meet essential performance, safety, and quality standards before entering the Indian market.

Risk Classification and License Requirements for the Parapodium Walking Frame

• Risk Class: A (Low risk)
• Regulatory Authority: State Licensing Authority for manufacturing (MD5 license)
• License Type: MD5 Manufacturing License (Form MD3 application)
• Test License: Required (Form MD13)
• Import License: MD15 License (Central Licensing Authority)

For Class A devices, the entire manufacturing licensing process typically spans 3–4 months, including testing, audit, and documentation.

Manufacturing License Process for Parapodium Walking Frame (MD5 License)

1. Obtain Test License (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license to send product samples to CDSCO-approved labs for testing. This process takes roughly 1.5 to 2 months.

2. Product Testing: Conduct product testing at government-recognized laboratories. Testing confirms compliance with Indian standards and essential principles.

3. Document Preparation: Compile all required documents such as Device Master File, Plant Master File, Risk Management File, and others.

4. Application Submission: File the MD5 manufacturing license application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit of the manufacturing facility and QMS. Check the list of notified bodies to select an authorized auditor.

6. Query Resolution: Respond promptly to any queries from CDSCO or the notified body.

7. License Grant on Form MD5: Upon successful review and audit, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required for Parapodium Walking Frame

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution (e.g., MOA/Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualifications and Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing device design, materials, and manufacturing
• Plant Master File (PMF) describing the manufacturing environment and processes
• Essential Principles Checklist confirming compliance with Indian medical device regulations
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU) compliant with regulatory standards
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Our comprehensive Device Master File guide and Plant Master File guide can help you prepare these critical files effectively.

Import License Process for Parapodium Walking Frame (MD15 License)

If you are an importer of the Parapodium walking frame, an MD15 import license is required from the Central Licensing Authority. The process involves:

1. Document Preparation: Collect documentation including Manufacturing License, Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.

2. Application Submission: File Form MD14 electronically via the CDSCO MD Online Portal.

3. Query Resolution: Address any clarifications from CDSCO promptly.

4. License Grant: After satisfactory review, the MD15 import license is issued.

The import process generally takes 5–6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Certificate
• CE Certificate (if marketed in Europe)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

For import licenses (MD15), expect around 5 to 6 months.

Government Fees and Costs

For Class A device manufacturing license (MD5):

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

Please note these fees exclude costs for notified body audits, product testing, and documentation preparation.

Common Challenges and Solutions

• Delays in Test License Approval: Start the MD13 application early and ensure all test samples meet CDSCO requirements.
• Incomplete Documentation: Use checklists and consult expert guides such as our MD5 License Guide to avoid missing files.
• Audit Non-compliance: Conduct thorough internal audits prior to notified body visits.
• Query Resolution Delays: Assign dedicated personnel to respond quickly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience and having supported 500+ companies, we provide end-to-end assistance for CDSCO licensing of Class A devices like the Parapodium walking frame. Our services include:

• Gap analysis and compliance consulting
• Document preparation for Device Master File, Plant Master File, and QMS
• Coordination with notified bodies and testing laboratories
• Application filing and follow-up

Getting Started with Your CDSCO License Application

1. Assess your current compliance status: Review your manufacturing setup and QMS.
2. Prepare and compile your documentation: Utilize expert guides and templates.
3. Apply for the test license (MD13): Submit via CDSCO MD Online Portal.
4. Coordinate product testing: Send samples to CDSCO-approved labs.
5. Plan for notified body audit: Select an audit body from the official Notified Bodies List.
6. Submit your MD5 application (Form MD3): Ensure all documents are in order.
7. Prepare for and respond to audits and queries: Maintain clear communication channels.

Embarking on your licensing journey with structured planning and expert guidance will significantly improve the chances of timely approval and market entry. Contact us to leverage our deep regulatory expertise for your Parapodium walking frame CDSCO licensing project.