CDSCO License for Inflatable penile prosthesis

Comprehensive Guide to CDSCO Licensing for Inflatable Penile Prosthesis (Class C Medical Device)

Inflatable penile prostheses (IPP) are sophisticated, sterile urological devices designed to aid patients suffering from erectile dysfunction by enabling selective penile tumescence and rigidity suitable for vaginal intercourse. Given their invasive nature and critical role in patient health, these devices fall under Class C risk classification as per the Central Drugs Standard Control Organisation (CDSCO) regulations. Navigating the regulatory pathway for such devices can be complex. With over 25 years of experience and having successfully assisted 500+ companies, we provide an expert, actionable roadmap for obtaining the necessary CDSCO license to manufacture or import IPPs in India.

CDSCO Regulatory Framework for Inflatable Penile Prosthesis

The CDSCO regulates medical devices under the Medical Device Rules 2017, classifying devices based on risk and intended use. Inflatable penile prostheses, due to their implantable nature and potential impact on patient safety, are categorized as Class C devices. This classification mandates stringent regulatory controls, overseen by the Central Licensing Authority (CLA), including comprehensive testing, documentation, and audits.

The specific notification governing this device is File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, which confirms its inclusion under regulatory scrutiny.

Risk Classification and License Requirements

• Device: Inflatable Penile Prosthesis
• Risk Class: Class C
• Regulatory Authority: Central Licensing Authority (CDSCO)
• Required License: MD9 Manufacturing License (Form MD7) or MD15 Import License (Form MD14) depending on whether you manufacture or import

Class C devices require:

• Thorough product testing by CDSCO-approved laboratories
• Detailed technical documentation including Device Master File and Plant Master File
• Compliance with Essential Principles, Risk Management, and Quality Management Systems
• Inspection and audit by CDSCO officials

For detailed device classification, you can refer to our Medical Device Classification guide.

Manufacturing License Process (MD9) for Inflatable Penile Prosthesis

Manufacturers of Class C devices like IPP must obtain an MD9 license from the Central Licensing Authority. The process involves:

1. Test License Application (Form MD13): Initially, obtain a test license valid for 12 months. This allows production of samples for laboratory testing.
2. Product Testing: Send samples to CDSCO approved testing labs. Refer to the Testing Laboratories list for authorized facilities.
3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles checklist, Risk Management files, test reports, labeling, Instructions for Use (IFU), and QMS documents.
4. License Application (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.
5. Audit & Inspection: CDSCO inspectors will conduct a detailed audit of your manufacturing facility and documentation.
6. Query Resolution: Respond promptly to any queries from CDSCO or auditors.
7. Grant of License: Upon satisfactory compliance, you will be granted an MD9 license (Form MD9).

For detailed insights on the MD9 process, see our MD9 License Guide.

Manufacturing License Documents Required

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

• Company Constitution: Incorporation certificate, partnership deed, or LLP agreement
• Proof of Ownership/Lease of Premises: Valid ownership documents or lease agreements
• Technical Staff Qualifications: CVs and certificates of qualified professionals
• Fire NOC and Pollution Control NOC: From respective authorities
• Device Master File (DMF): Detailed product design, specifications, manufacturing processes. Our Device Master File guide offers comprehensive coverage.
• Plant Master File (PMF): Manufacturing facility details, quality systems. Learn how to prepare one in our Plant Master File Guide.
• Essential Principles Checklist: Compliance with safety and performance requirements
• Risk Management File: Per ISO 14971 standards, including hazard analysis and risk mitigation. Check our Risk Management resource.
• Test Reports: From CDSCO-approved labs
• Labels and IFU: In line with CDSCO guidelines
• Quality Management System (QMS) Documents: Usually ISO 13485:2016 certification

Import License Process (MD15) for Inflatable Penile Prosthesis

For importers, the MD15 license is mandatory and issued by the Central Licensing Authority.

1. Document Preparation: Compile required documents including manufacturing license of the product in the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device Master File, Plant Master File, Wholesale License, and company constitution.
2. Application Submission: File the MD15 application using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Address any CDSCO queries promptly.
4. Grant of License: After review, the MD15 license will be issued.

For a detailed walkthrough, refer to our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

The timelines assume prompt submission of documents and swift resolution of queries. Delays often arise from incomplete documentation or audit findings.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: Rs. 50,000
  • Per Product Fee: Rs. 1,000

• Test License (MD13):

  • Included within MD9 application time, separate fee applies as per CDSCO norms

• MD15 Import License Fees: (approximate USD conversion)

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

Additional costs include:

• Testing fees from accredited labs
• Audit fees payable to notified bodies or CDSCO
• Consultancy and documentation preparation fees

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents delay approval. Solution: Use detailed checklists and seek expert review before submission.

• Delayed Testing: Government labs may have backlogs. Solution: Plan sample submission early and consider multiple approved labs.

• Audit Non-Compliance: Facilities not meeting GMP or QMS standards can fail audits. Solution: Conduct internal pre-audit assessments and implement corrective actions.

• Query Resolution Delays: Late responses stall the process. Solution: Assign dedicated regulatory personnel for timely communication.

• Understanding Complex Regulations: Regulatory language can be daunting. Solution: Partner with experienced consultants who understand CDSCO nuances.

Expert Consultation and Support

With over two decades of regulatory consulting expertise, we have guided over 500 companies through CDSCO licensing for complex Class C devices like the inflatable penile prosthesis. Our services include:

• Gap analysis and readiness assessment
• Comprehensive documentation preparation including DMF and PMF
• Coordination with CDSCO and notified bodies
• Pre-audit inspections and training
• End-to-end project management ensuring timely approvals

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C and understand the implications.
2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File. Use our guides linked above for detailed instructions.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Select a CDSCO-approved lab from the Testing Laboratories list and plan sample submission.
5. Prepare for Audit: Ensure your manufacturing site complies with GMP and QMS requirements.
6. Submit MD9 Application: After testing success, submit your Form MD7 application online.
7. Engage with CDSCO: Respond promptly to queries and facilitate audit inspections.

Embarking on this journey with expert guidance maximizes your chances of timely approval and successful market entry. Contact us today to leverage our proven expertise and tailored regulatory solutions for your inflatable penile prosthesis licensing needs.