CDSCO License for Wrist joint metal/polymer semi-constrained  cemented  prosthesis

Comprehensive Guide to CDSCO Licensing for Wrist Joint Metal/Polymer Semi-Constrained Cemented Prosthesis (Class C Orthopaedic Implant)

At our consultancy, with over 25 years of experience and 500+ successful CDSCO licensing projects, we understand the nuances of medical device regulation in India. Today, we focus on the Wrist Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, a Class C orthopaedic implant, intended for implantation to replace the wrist joint. This device falls under risk class C as per the CDSCO notification 29/Misc/3/2017-DC (292) dated 06.06.2018.

Navigating CDSCO compliance for such an advanced implant requires precise knowledge of the regulatory framework, timelines, documentation, and cost structures. Here’s an expert, step-by-step breakdown to help manufacturers and importers successfully obtain manufacturing and import licenses.

CDSCO Regulatory Framework for Wrist Joint Prostheses

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Orthopaedic implants like wrist joint prostheses are classified as Class C devices due to their invasive and implantable nature, posing moderate to high risk.

As a Class C device, regulatory oversight is stringent, and the licensing authority is the Central Licensing Authority (CLA). Both manufacturing and import require separate CDSCO licenses:

• Manufacturing License: MD9 License (Application Form MD7)
• Import License: MD15 License (Application Form MD14)

All applications must be submitted through the official CDSCO MD Online Portal.

Risk Classification and License Requirements

The wrist joint metal/polymer semi-constrained cemented prosthesis is categorized as:

• Risk Class: C
• Category: Orthopaedic Implants
• Regulatory Requirements: Manufacturing license (MD9) and Import license (MD15)

This classification demands rigorous testing, documentation, and audits by CDSCO inspectors.

For detailed risk classification understanding, refer to our Medical Device Classification guide.

Manufacturing License Process for Class C Devices (MD9 License)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 manufacturing license, you must secure a test license on Form MD13. This allows you to manufacture limited quantities for testing purposes.

• Duration: 1.5 to 2 months
• Key Action: Submit application via CDSCO MD Online Portal

Step 2: Product Testing

Samples must be tested at CDSCO-approved government laboratories to ensure compliance with Indian standards. You can find an updated list of Testing Laboratories here.

Testing covers biocompatibility, mechanical strength, sterilization validation, and other relevant performance parameters.

Step 3: Documentation Preparation

Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, quality management system (QMS) documents, and test reports.

• Refer to our Device Master File Guide for detailed insights.
• For plant-related documentation, see our Plant Master File Guide.

Step 4: Application for MD9 License (Form MD7)

Submit the MD9 license application along with all supporting documents on the CDSCO MD Online Portal.

Step 5: CDSCO Inspection and Audit

CDSCO inspectors will conduct an on-site audit to verify compliance with manufacturing practices and quality systems.

Step 6: Query Resolution

You may receive queries from the CDSCO department or auditors. Prompt and comprehensive responses are crucial to avoid delays.

Step 7: Grant of MD9 License

Upon satisfactory inspection and document review, CDSCO will grant the manufacturing license on Form MD9.

Timeline and Cost Summary for MD9 License

Government Fees:

• Application Fee: INR 50,000
• Per Product Fee: INR 1,000

For a detailed walkthrough, consult our MD9 License Guide.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File as per ISO 14971 standards (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 Certification Preferred)

Import License Process for Class C Devices (MD15 License)

Step 1: Document Preparation

Prepare thorough documentation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.

Step 2: Application Submission (Form MD14)

Apply for the MD15 import license via the CDSCO MD Online Portal.

Step 3: Query Resolution

Respond promptly to any queries raised by the CDSCO.

Step 4: Grant of Import License (Form MD15)

After satisfactory review, the import license will be issued.

Timeline and Cost Summary for MD15 License

Government Fees:

• Class C Devices: INR 3,000 per site
• INR 1,500 per product

For detailed import licensing insights, see our Import License Guide.

Common Challenges and Solutions

Challenge 1: Delayed Testing Results

• Solution: Choose CDSCO-approved labs with proven turnaround times and maintain clear communication throughout the testing phase.

Challenge 2: Incomplete Documentation

• Solution: Use expert-reviewed checklists and templates for DMF, PMF, and risk management files to avoid repeated queries.

Challenge 3: Audit Non-Compliance

• Solution: Conduct mock audits internally or with consultants to ensure adherence to quality systems before CDSCO inspection.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Our team’s extensive experience in CDSCO licensing ensures you avoid common pitfalls and accelerate market entry. We assist with:

• Preparing robust technical documentation tailored to your wrist joint prosthesis
• Coordinating with notified bodies and testing laboratories
• Managing audit readiness and compliance
• Liaising with CDSCO and addressing queries

Contact us early in your product development cycle to streamline your licensing journey.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your device as Class C using reliable resources.
2. Initiate Test License Application: File Form MD13 for the test license via the CDSCO MD Online Portal.
3. Engage Accredited Testing Labs: Ensure samples are tested at government-approved facilities.
4. Prepare Documentation: Utilize our DMF and PMF guides to develop comprehensive files.
5. Plan for Audit: Schedule internal audits and prepare your manufacturing site.
6. Submit Manufacturing License Application (MD9): Apply using Form MD7 post successful testing.
7. For Importers: Concurrently, prepare import dossiers and apply for MD15 license.

By following this detailed roadmap, manufacturers and importers of wrist joint prostheses can confidently navigate the CDSCO regulatory landscape, ensuring compliance and timely market access.

For personalized assistance, reach out to our regulatory experts who have successfully guided 500+ companies through similar processes.

For further reading and resources, explore:

• CDSCO MD Online Portal
• List of Notified Bodies for Audit
• Device Master File Guide
• Medical Device Classification
• Risk Management Implementation