CDSCO License for Penile inflatable implant

Comprehensive Guide to CDSCO Licensing for Penile Inflatable Implant (Class D Medical Device)

With over 25 years of experience supporting more than 500 medical device companies, we understand the nuanced regulatory landscape of India. For manufacturers and importers aiming to market the penile inflatable implant—a Class D internal prosthetic replacement device regulated under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018—securing the appropriate CDSCO license is a critical step. This guide provides a detailed roadmap to help you navigate the process efficiently and compliantly.

Understanding the Penile Inflatable Implant and Its Regulatory Importance

The penile inflatable implant is an advanced internal prosthetic designed for patients suffering from erectile impotence. Implanted surgically, it consists of cylinders within the penis, a fluid reservoir in the abdomen, and a manual pump located subcutaneously in the scrotum. Given its implantable nature and high-risk profile, the device falls under Class D—requiring rigorous regulatory oversight to ensure safety and efficacy.

CDSCO Regulatory Framework for Class D Internal Prosthetic Replacements

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. Class D devices like the penile inflatable implant are classified as high-risk due to their invasive use and critical function. Consequently, licensing is centralized and governed by stringent standards involving product testing, clinical data evaluation, audits, and quality management system (QMS) compliance.

You can verify your device classification and applicable regulations via the Medical Device Classification guide.

Risk Classification and License Requirements

• Device Risk Class: D (High Risk)
• License Type: Manufacturing License MD9 (for domestic manufacturing)
• Authority: Central Licensing Authority (CDSCO HQ, New Delhi)
• Applicable Notification: 29/Misc/3/2017-DC (292) dated 06.06.2018

Manufacturing License Process for Penile Inflatable Implant (MD9 License)

The end-to-end process for obtaining the MD9 license generally spans 4 to 5 months and involves the following steps:

1. Test License (Form MD13): Initiate with a test license application to legally manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.
2. Product Testing: Obtain product testing from CDSCO-approved testing laboratories. Testing includes biocompatibility, mechanical performance, and radiopacity verification as per Indian and international standards.
3. Document Preparation: Compile comprehensive technical and quality documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. MD9 Application (Form MD7): Submit your manufacturing license application through the CDSCO MD Online Portal.
5. Audit & Inspection: CDSCO inspectors conduct onsite audits to verify compliance with QMS requirements and manufacturing processes.
6. Query Resolution: Address any queries or deficiencies raised by the CDSCO or notified bodies promptly.
7. License Grant: Upon satisfactory compliance, CDSCO issues the manufacturing license in Form MD9.

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

Manufacturing License Required Documents

To ensure a smooth application, prepare the following mandatory documents:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Details of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications, design, and manufacturing processes (DMF Guide)
• Plant Master File (PMF) describing manufacturing facilities and processes (PMF Guide)
• Essential Principles Checklist confirming compliance with Indian medical device regulations
• Risk Management File demonstrating systematic risk assessment and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories)
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Penile Inflatable Implants

For importers, the MD15 import license issued by the Central Licensing Authority governs the legal import of Class D devices:

• Application: Submit Form MD14 on the CDSCO MD Online Portal.
• Documents Required: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
• Processing Time: Approximately 5 to 6 months.
• Fees: Class D devices incur $3000 per site and$1500 per product.

Our detailed Import License Guide can assist in preparing a robust submission.

Timeline and Processing Duration

Import license processing typically takes 5 to 6 months.

Government Fees and Costs

• MD9 Manufacturing License:
  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000
• MD13 Test License: Nominal fees apply as per CDSCO schedule.
• MD15 Import License:
  • $3000 per site
  • $1500 per product

Budgeting for consultancy, testing, and audit-related costs is also essential.

Common Challenges and Practical Solutions

• Delays in Product Testing: Engage early with CDSCO-approved labs and schedule testing to avoid bottlenecks.
• Incomplete Documentation: Use checklists and templates for DMF and PMF preparation; our Device Master File guide can be invaluable.
• Audit Non-Compliance: Pre-audit assessments by experienced consultants can identify gaps before CDSCO inspections.
• Query Resolution Delays: Maintain prompt communication with CDSCO officials and have a dedicated regulatory team to handle queries.

Expert Consultation and Support

Navigating the complexities of Class D device licensing requires specialized expertise. Our seasoned consultants bring in-depth knowledge of CDSCO regulations, audit preparation, and document compilation to streamline your application. We provide:

• Gap analysis and readiness assessments
• Customized documentation support
• Liaison with notified bodies and testing labs
• Post-approval compliance and vigilance guidance

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device risk class and regulatory requirements.
2. Prepare Test License Application: Initiate Form MD13 submission via the CDSCO MD Online Portal.
3. Engage with Approved Testing Labs: Schedule product testing early to avoid delays.
4. Compile Technical Documentation: Utilize expert resources and templates to build your DMF, PMF, and Risk Management files.
5. Plan for Quality Management System Implementation: ISO 13485 compliance is critical for successful licensing.
6. Schedule Pre-Audit Support: Consider a mock audit to identify potential compliance gaps.
7. Submit Manufacturing License Application (Form MD7): Once testing and documentation are complete.

Starting early and leveraging expert advice can significantly shorten your time to market and ensure compliance for your penile inflatable implant in India. For personalized assistance, reach out to our regulatory experts who have successfully guided over 500 companies through the CDSCO licensing journey.