CDSCO License for A testicular prosthesis

Comprehensive Guide to CDSCO Licensing for Testicular Prosthesis (Class D Medical Device)

A testicular prosthesis is a surgically implanted device made of solid or gel-filled silicone rubber designed to simulate a natural testicle. Classified under Internal Prosthetic Replacements and designated as a Class D medical device by the CDSCO, this device carries the highest risk category due to its implantable nature and direct impact on patient health. Compliance with CDSCO’s stringent regulatory framework is mandatory before manufacturing or importing such devices in India.

With over 25 years of experience assisting 500+ manufacturers and importers, we provide detailed, actionable insights tailored for your testicular prosthesis regulatory journey.

CDSCO Regulatory Framework for Testicular Prosthesis

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Devices Rules, 2017. Testicular prostheses fall under Class D due to their implantable, high-risk status, requiring approval from the Central Licensing Authority.

The regulatory process involves:

• Obtaining a Test License (MD13) for initial product testing
• Submission of a Manufacturing License (MD9) application
• Product testing at CDSCO-approved labs
• Audit and inspection by CDSCO officials

This process ensures patient safety through rigorous evaluation of quality management systems, risk management, and product performance.

Risk Classification and License Requirements

Your testicular prosthesis is classified as Class D per CDSCO Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. This classification mandates the following:

• License Type: MD9 Manufacturing License (Form MD7)
• Licensing Authority: Central Licensing Authority, CDSCO
• Mandatory product testing and factory inspection
• Compliance with ISO 13485:2016 and Essential Principles of safety and performance

The MD9 license application process is comprehensive and typically takes 4-5 months from start to finish.

Manufacturing License Process for Class D Devices (MD9 License)

Obtaining an MD9 license for your testicular prosthesis involves sequential steps:

1. Test License Application (Form MD13): Apply for a test license to legally manufacture the device for testing purposes. This takes approximately 1.5 to 2 months.

2. Product Testing: Submit samples to CDSCO-recognized testing laboratories (List of Testing Laboratories) for conformity assessment.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS documentation.

4. MD9 License Application (Form MD7): Submit your complete application online via the CDSCO MD Online Portal.

5. Audit and Inspection: CDSCO inspectors conduct a thorough audit of your manufacturing site and quality systems.

6. Query Resolution: Address any observations or deficiencies raised during audit or document review.

7. License Grant: Upon satisfactory compliance, CDSCO grants the MD9 license (Form MD9).

For detailed guidance on the MD9 license process, refer to our MD9 License Guide.

Manufacturing License Documents Required for Testicular Prosthesis

To ensure a smooth approval process, prepare the following key documents:

• Company Constitution: Registration certificates and incorporation documents.
• Proof of Premises Ownership or Lease: Valid property documents.
• Technical Staff Details: Qualification and experience of responsible persons.
• Fire NOC and Pollution Control NOC: Compliance certificates.
• Device Master File (DMF): Detailed information about the prosthesis design, specifications, and manufacturing process. Our Device Master File Guide can help you prepare this critical file.
• Plant Master File (PMF): Overview of your manufacturing facility and quality controls. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating conformity with regulatory safety and performance requirements.
• Risk Management File: Documenting risk analysis, evaluation, and mitigation strategies. Learn more about Risk Management.
• Test Reports: Results from CDSCO-approved labs.
• Labeling and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
• Quality Management System (QMS) Documents: Procedures, work instructions, and records aligned with ISO 13485.

Import License Process for Testicular Prosthesis (MD15 License)

If you intend to import the testicular prosthesis into India, you must secure an MD15 import license from the Central Licensing Authority. The import process involves:

1. Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, wholesale licenses, and company constitution.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond promptly to any clarifications requested by CDSCO.

4. License Grant: The MD15 license is typically granted within 5-6 months.

For a detailed walkthrough, consult our Import License Guide.

Import License Documents Required

Key documents for import licensure include:

• Valid manufacturing license from the exporting country
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license
• Company registration documents

Timeline and Processing Duration

Import license (MD15) processes typically take 5-6 months.

Government Fees and Costs

The fee structure for your testicular prosthesis (Class D) includes:

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• Test License (MD13): Applicable fees as per CDSCO norms

Note: These fees are payable online through the CDSCO portal.

For imports:

• Class D: $3000 per site +$1500 per product approximately

Budget for additional costs like lab testing fees, notified body audit charges, and consultant fees.

Common Challenges and Solutions

Challenge 1: Comprehensive documentation preparation can be overwhelming.

Solution: Utilize templates and expert guidance for Device and Plant Master Files, Risk Management, and QMS documents. We offer customized document preparation support.

Challenge 2: Delays due to incomplete test reports or audit observations.

Solution: Engage with CDSCO-approved testing labs early (Testing Laboratories List) and conduct internal mock audits before official inspections.

Challenge 3: Navigating the CDSCO MD Online Portal.

Solution: Our step-by-step assistance ensures error-free online submissions, timely fee payments, and query management.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape for high-risk devices like testicular prostheses demands expertise and precision. With over 25 years and 500+ successful client projects, we provide end-to-end support including:

• Regulatory strategy and classification advice
• Document drafting and review
• Liaison with CDSCO and notified bodies
• Audit preparedness and training
• Post-license compliance support

Leverage our extensive experience to avoid pitfalls and accelerate your market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class D status using CDSCO classifications (Medical Device Classification).

2. Engage Early with Testing Labs: Identify and coordinate with government-approved laboratories for device testing.

3. Prepare Key Documents: Start compiling your Device Master File, Plant Master File, and Risk Management File with professional assistance.

4. Apply for Test License (MD13): Submit your test license application for initial production.

5. Plan for Audit: Select a notified body from the Notified Bodies List for your manufacturing site audit.

6. Submit MD9 Application: After successful testing and documentation, apply online through the CDSCO MD Online Portal.

7. Prepare for Queries: Stay responsive to CDSCO queries to avoid delays.

Your journey to obtaining a CDSCO license for your testicular prosthesis will be smoother with expert guidance. Contact us today to initiate your registration process and ensure compliance with all regulatory standards.