CDSCO License for Shoulder joint glenoid (hemi- shoulder) metallic cemented  prosthesis

Regulatory Overview: Shoulder Joint Glenoid (Hemi-Shoulder) Metallic Cemented Prosthesis

The Shoulder Joint Glenoid (hemi-shoulder) metallic cemented prosthesis is a Class C orthopaedic implant designed to replace part of the shoulder joint. As an implantable medical device, it falls under stringent regulatory scrutiny by the Central Drugs Standard Control Organization (CDSCO) in India. Compliance with CDSCO regulations is critical to ensure patient safety, device efficacy, and legal market access.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we provide you with a detailed roadmap tailored to this high-risk device.

CDSCO Regulatory Framework for Orthopaedic Implants (Class C Devices)

Orthopaedic implants like the shoulder joint prosthesis are categorized as Class C medical devices by CDSCO due to their invasive nature and critical function. They require a manufacturing license known as the MD9 license granted by the Central Licensing Authority. The regulatory framework includes:

• Obtaining a Test License (MD13) for initial product testing
• Product testing at CDSCO-approved laboratories
• Document submission and detailed technical dossier preparation
• Inspection and audit by CDSCO officials
• Resolution of regulatory queries

You can initiate your application through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Shoulder Joint Prosthesis

This device is classified as Class C, which implies medium to high risk. According to CDSCO:

• License type: MD9 Manufacturing License
• Authority: Central Licensing Authority
• Total processing time: Approximately 4-5 months (including test license, testing, documentation, audit)
• Fees: Rs 50,000 per application + Rs 1,000 per product

For a comprehensive understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD9) for Class C Devices

The MD9 licensing process involves several critical steps:

1. Apply for Test License (Form MD13): Mandatory for product testing approval; processing takes about 1.5 to 2 months.
2. Product Testing: Conducted at CDSCO-approved labs to verify safety and performance. Refer to the List of Testing Laboratories for authorized facilities.
3. Dossier Preparation: Assemble technical documents including Device Master File, Plant Master File, Risk Management File, and more.
4. Submit MD9 Application (Form MD7): Apply via the CDSCO portal.
5. Audit and Inspection: Conducted by CDSCO inspectors to verify compliance.
6. Respond to Queries: Address any observations raised during inspection.
7. Grant of License: Issued on Form MD9 after successful compliance.

This process ensures that the device meets all regulatory standards before market entry.

Essential Documents Required for MD9 Manufacturing License

Accurate and complete documentation is the foundation of a smooth approval process. For your shoulder joint prosthesis, prepare the following:

• Company Constitution: Certificate of incorporation and legal status
• Proof of Premises Ownership: Rent agreement or sale deed
• Technical Staff Credentials: Qualification and experience certificates of manufacturing and quality personnel
• Fire NOC and Pollution Control NOC: Compliance certificates from local authorities
• Device Master File (DMF): Detailed description of device design, materials, manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Overview of manufacturing facility and quality systems (Plant Master File Guide)
• Essential Principles Checklist: Demonstrating conformity with safety and performance requirements
• Risk Management File: Documentation of risk analysis and mitigation strategies (Risk Management Guide)
• Test Reports: From CDSCO-approved laboratories validating device performance
• Labels and Instructions for Use (IFU): Compliant with regulatory standards
• Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs

Ensuring these documents are precise, complete, and well-organized can significantly accelerate the review process.

Import License Process (MD15) for Shoulder Joint Prosthesis

For importers, the MD15 license is mandatory to legally bring the device into the Indian market. The process is managed by the Central Licensing Authority and typically takes 5-6 months.

Key steps include:

• Preparation of comprehensive documentation (Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, Company Constitution)
• Submission of application via CDSCO MD Online Portal
• Queries resolution
• Grant of MD15 license

Government fees vary by device class; for Class C & D devices, it is approximately $3000 per site plus$1500 per product. Detailed guidance is available in our Import License Guide.

Timeline and Processing Duration

Planning your project timeline with these benchmarks helps avoid costly delays.

Government Fees and Associated Costs

• MD9 License Application: Rs 50,000
• Per Product Fee: Rs 1,000
• Test License (MD13): Included in manufacturing license process
• Product Testing: Variable, depends on tests required (typically Rs 50,000 – Rs 1,00,000)
• Audit Fees: Usually covered under CDSCO inspection costs

Budgeting for these expenditures upfront ensures smoother financial planning.

Common Challenges and Practical Solutions

Challenge: Delays in Product Testing

Solution: Engage with CDSCO-approved labs early and schedule testing slots promptly. Maintain clear communication and provide complete samples to avoid retesting.

Challenge: Incomplete or Inaccurate Documentation

Solution: Utilize checklists and expert consultation to prepare thorough Device and Plant Master Files, Risk Management Files, and QMS documentation.

Challenge: Audit Non-Compliance

Solution: Conduct internal audits and mock inspections to identify and rectify gaps before CDSCO inspection.

Challenge: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to promptly address queries with detailed, evidence-backed responses.

Expert Consultation and Support

Navigating CDSCO licensing for Class C orthopaedic implants is complex. Our consultancy offers:

• End-to-end support from test license application to final MD9 grant
• Document preparation and review services
• Coordination with notified bodies and CDSCO inspectors
• Training and mock audit sessions
• Assistance with risk management and QMS compliance

Our proven track record with 500+ clients ensures your licensing journey is efficient and successful.

Getting Started with Your CDSCO MD9 License Application

To initiate your regulatory pathway for the Shoulder Joint Glenoid (hemi-shoulder) metallic cemented prosthesis:

1. Register on the CDSCO MD Online Portal
2. Prepare and submit the Test License application (Form MD13)
3. Arrange product testing at authorized laboratories
4. Compile comprehensive technical documentation (Device Master File, Plant Master File, Risk Management File, etc.)
5. Submit the MD9 manufacturing license application (Form MD7)
6. Coordinate with CDSCO inspectors for audit scheduling
7. Address queries swiftly and thoroughly

Starting early and seeking expert guidance can dramatically improve your chances of timely approval. Contact us to leverage our extensive expertise and ensure your shoulder prosthesis gains CDSCO approval with minimal hassle.