CDSCO License for Penile rigidity implant

Comprehensive Guide to CDSCO Licensing for Penile Rigidity Implants (Class C Medical Devices)

When it comes to penile rigidity implants, a specialized internal prosthetic replacement designed to treat erectile dysfunction by providing penile rigidity, navigating the Indian regulatory landscape is critical. Classified as a Class C medical device under the CDSCO framework, these implants require stringent compliance to ensure patient safety and market access.

With over 25 years of regulatory consulting experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide you with a detailed, actionable roadmap to secure your manufacturing or import license smoothly.

CDSCO Regulatory Framework for Penile Rigidity Implants

Penile rigidity implants fall under the broad category of Internal Prosthetic Replacements, notified under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. As a Class C device, these implants demand a central licensing authority approval, meaning manufacturers and importers must engage with CDSCO headquarters in New Delhi.

The regulatory process involves compliance with the Medical Device Rules, 2017, including testing, documentation, and audits to demonstrate conformance with Indian and international standards.

Risk Classification and License Requirements

Class C devices are considered medium to high-risk devices, necessitating an MD9 manufacturing license for domestic production and an MD15 import license for importers.

• MD9 License: For manufacturers of Class C devices, issued by the CDSCO Central Licensing Authority.
• MD15 License: For importers, also issued centrally.

Understanding the risk classification helps define the scope of documentation, audit procedures, and timelines.

Manufacturing License Process (MD9)

Acquiring an MD9 license for penile rigidity implants is a multi-step process:

1. Test License Application (Form MD13): Before the full manufacturing license, you must obtain a test license for 1.5–2 months.
2. Product Testing: Submit samples to government-approved laboratories for safety and performance testing.
3. Document Preparation: Compile all technical and quality documents.
4. License Application (Form MD7): Submit your MD9 application via the CDSCO MD Online Portal.
5. CDSCO Audit: CDSCO inspectors audit your manufacturing facility, quality management system, and product documentation.
6. Query Resolution: Respond promptly to any queries or deficiencies raised during the review.
7. License Grant: Upon satisfactory compliance, CDSCO issues the manufacturing license (Form MD9).

For detailed guidance, our MD9 License Guide offers stepwise instructions.

Manufacturing License Documents Required

Preparing a meticulous document dossier is crucial. For penile rigidity implants, ensure you have the following:

• Company Constitution Documents: Incorporation certificate, MOA/AOA.
• Proof of Premises Ownership: Rent agreement or ownership deed.
• Technical Staff Credentials: CVs, qualifications, experience.
• Fire NOC and Pollution Control NOC: From local authorities.
• Device Master File (DMF): Detailed design and manufacturing process documentation. See our Device Master File Guide.
• Plant Master File (PMF): Details of manufacturing infrastructure. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Compliance with safety and performance requirements.
• Risk Management File: Per ISO 14971 standards. Learn more at our Risk Management resource.
• Test Reports: From CDSCO-approved testing laboratories. Refer to the Testing Laboratories list.
• Labels and Instructions for Use (IFU): As per Indian regulatory requirements.
• Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification.

Import License Process (MD15)

For companies importing penile rigidity implants, the MD15 license is mandatory before market entry in India.

Steps include:

1. Document Compilation: Manufacturing license, Free Sale Certificate from country of origin, CE Certificates, ISO 13485:2016 certification.
2. Application Submission: File Form MD14 through the CDSCO MD Online Portal.
3. Review and Query Handling: Address any clarifications raised during the evaluation.
4. License Issuance: CDSCO issues the MD15 license.

This process typically takes 5-6 months.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License for the Importer
• Company Constitution Documents

Timeline and Processing Duration

Bear in mind that delays often arise from incomplete documentation or slow responses to queries.

Government Fees and Costs

• MD9 License: Rs 50,000 per application + Rs 1,000 per product.
• Test License (MD13): Fees embedded within the MD9 process.
• MD15 Import License Fees: Varies by device class; for Class C devices, typically $3,000 per site +$1,500 per product.

Budgeting for these fees upfront helps avoid surprises.

Common Challenges and Solutions

Challenge: Delayed product testing due to backlog at government labs.

Solution: Plan sample submission early and consider pre-testing at notified private labs listed in the Testing Laboratories list.

Challenge: Incomplete documentation leading to multiple rounds of queries.

Solution: Use expert consultants for document gap analysis and preparation.

Challenge: Facility audit non-compliance.

Solution: Conduct internal mock audits and train staff on CDSCO audit expectations.

Expert Consultation and Support

Given the complexity of Class C device licensing, expert regulatory support significantly expedites approvals. Our team has guided over 500 companies through successful MD9 and MD15 applications, ensuring compliance with CDSCO rules and international best practices.

We assist with:

• Gap analysis of your manufacturing/import processes
• Document preparation and review
• Liaison with CDSCO officials
• Audit readiness training

Getting Started with Your CDSCO License Application

1. Assess your Device Classification: Confirm your device as Class C per the Medical Device Classification guide.
2. Collect Required Documents: Begin assembling your Device Master File, Plant Master File, and QMS certifications.
3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs early.
5. Prepare for Audit: Engage a notified body or CDSCO inspectors and conduct internal audits.
6. Submit MD9 Application: Apply on Form MD7 once testing and documentation are complete.

Taking these steps early streamlines the licensing process and positions your penile rigidity implant for successful introduction into the Indian market.

For personalized assistance, reach out to our regulatory consulting experts who have a proven track record in medical device approvals across India.

Embark confidently on your regulatory journey with our expert guidance, ensuring your penile rigidity implant meets CDSCO requirements efficiently and compliantly.