CDSCO License for Pliable-polymer dental regeneration membrane, bio absorbable, tacked

Comprehensive Guide to CDSCO Licensing for Pliable-Polymer Dental Regeneration Membranes (Class C)

As a trusted regulatory consultancy with over 25 years and more than 500 successful CDSCO license approvals, we understand the unique challenges manufacturers and importers face when navigating India’s medical device regulations. This guide focuses on the pliable-polymer dental regeneration membrane, bio-absorbable, tacked—a Class C dental device designed to aid periodontal regeneration by acting as a barrier to soft tissue down-growth.

Understanding Your Device and Its Regulatory Importance

Your device, a sterile bio-absorbable dental membrane, plays a critical role in dental regenerative therapy. Given its invasive use and bio-absorbable nature, it is rightly classified as Class C under CDSCO regulations, reflecting a moderate to high risk profile requiring stringent regulatory oversight.

Ensuring compliance with CDSCO's licensing requirements is not just regulatory bureaucracy; it guarantees patient safety, device efficacy, and market credibility. Early and thorough preparation significantly smooths the approval journey.

CDSCO Regulatory Framework for Dental Devices - Class C

India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (2017). Class C devices, including your dental membrane, fall under central licensing authority jurisdiction due to their risk profile and clinical implications.

The applicable notification for your device is 29/Misc./03/2020-DC (140) Part-5, issued on 10.10.2022, which clearly outlines regulatory expectations for dental regenerative materials.

Risk Classification and License Requirements

According to CDSCO’s classification:

• Class C devices require an MD9 Manufacturing License (Form MD7) for local manufacture.
• For importers, an MD15 Import License (Form MD14) issued by CDSCO is mandatory.

Your device’s bio-absorbable, sterile nature and intended use in regeneration place it firmly in Class C, mandating a rigorous approval process.

Manufacturing License Process (MD9) for Class C Devices

Obtaining an MD9 license involves multiple steps:

1. Test License (Form MD13): Initially, manufacturers must apply for a test license, valid for 6 months, allowing product testing in a CDSCO-approved laboratory.
2. Product Testing: Testing must be conducted at government-recognized labs to verify compliance with Indian standards.
3. Document Preparation: Assemble a comprehensive dossier including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and more.
4. Application Submission: File Form MD7 through the CDSCO MD Online Portal with all required documents.
5. Audit and Inspection: CDSCO inspectors will audit the manufacturing facility for compliance with QMS and regulatory requirements.
6. Query Resolution: Respond to any queries raised during the audit or document review promptly.
7. License Grant: Upon satisfactory compliance, CDSCO issues the MD9 license.

Manufacturing License Documents Required for MD9

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing device design and specifications (Guide here)
• Plant Master File outlining manufacturing processes and infrastructure (Guide here)
• Essential Principles Checklist confirming compliance with safety and performance
• Risk Management File documenting identified and mitigated risks (More on Risk Management)
• Product Test Reports from CDSCO-approved laboratories (Testing Labs List)
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Import License Process (MD15) for Class C Devices

For importing your dental membrane into India:

1. Document Preparation: Collect essential documents including the manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files.
2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
3. Review and Queries: CDSCO reviews documents; applicants must respond swiftly to queries.
4. License Grant: Typically issued within 5-6 months post submission.

Import License Documents Required

• Valid foreign Manufacturing License
• Free Sale Certificate from the country of origin
• ISO 13485:2016 QMS Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution

Timeline and Processing Duration

For Class C devices like your dental membrane, expect a total of approximately 4 to 5 months for manufacturing licenses and 5 to 6 months for import licenses.

Government Fees and Costs

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• MD15 Import License: $3,000 per site +$1,500 per product
• MD13 Test License: Fees vary by state but generally included in application

These costs reflect the regulatory rigor required for Class C devices and should be budgeted accordingly.

Common Challenges and Practical Solutions

• Delayed Testing Results: Engage early with CDSCO-approved labs (Testing Labs List) to schedule tests in advance.
• Incomplete Documentation: Utilize checklists and expert review to ensure completeness; leverage our Device Master File guide.
• Audit Non-Compliance: Prepare your facility per CDSCO guidelines and conduct internal audits before official inspections.
• Query Management Delays: Assign dedicated regulatory personnel to respond promptly.

Expert Consultation and Support

Navigating CDSCO’s licensing demands can be complex. Our seasoned consultants have guided over 500 companies through this exact process, specializing in Class C dental devices. We provide end-to-end support—from dossier preparation, test license acquisition, coordinating with notified bodies, to audit readiness and query resolution.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your risk class via CDSCO’s Medical Device Classification.
2. Initiate Test License Application: Submit Form MD13 through the CDSCO MD Online Portal.
3. Engage Accredited Testing Labs: Book testing with labs from the official list.
4. Compile Required Documentation: Prepare your Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management documentation thoroughly.
5. Plan for Audit: Identify and schedule an audit with CDSCO inspectors.
6. Submit Application: Apply for the MD9 manufacturing license (Form MD7) on the online portal.
7. Stay Responsive: Monitor your application and respond promptly to any CDSCO queries.

By following these tailored steps, manufacturers and importers of pliable-polymer dental regeneration membranes can confidently navigate the regulatory landscape, ensuring timely market entry and compliance.

For personalized assistance and detailed project planning, connect with our expert team specializing in CDSCO medical device licensing.