CDSCO License for Collagen dental regeneration membrane

Comprehensive Guide to CDSCO Licensing for Collagen Dental Regeneration Membrane

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the complexities manufacturers and importers face in India’s evolving medical device landscape. The Collagen dental regeneration membrane, classified as a Class C medical device, plays a critical role in periodontal regeneration and dental implantology. Navigating the CDSCO approval process smoothly is essential to bring such innovative products to the Indian market compliantly.

CDSCO Regulatory Framework for Collagen Dental Regeneration Membranes

The Central Drugs Standard Control Organisation (CDSCO) governs the regulation of medical devices in India. The Collagen dental regeneration membrane falls under the Dental category and is notified under the Gazette Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. This device is classified as Class C due to its invasive nature and medium to high risk associated with its use in tissue regeneration around dental implants.

Risk Classification and License Requirements

Class C devices require stringent regulatory oversight. For your Collagen dental regeneration membrane, the applicable manufacturing license is the MD9 license (Application Form MD7), granted by the Central Licensing Authority of CDSCO.

• License Type: MD9 (Central Authority)
• Risk Class: C
• Processing Time: Approximately 4-5 months
• Fees: INR 50,000 per application + INR 1,000 per product

For importers, an MD15 import license (Form MD14) is necessary, which involves separate documentation and fees.

Manufacturing License Process (MD9)

Obtaining an MD9 license involves a multi-step process:

1. Test License (Form MD13): Initially, a test license is required to manufacture the device for testing purposes. This stage typically takes 1.5 to 2 months.
2. Product Testing: The collagen membrane must be tested at CDSCO-approved laboratories to validate safety, sterility, and biocompatibility. Refer to the list of testing laboratories for recognized labs.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) records.
4. Application Submission: Submit the MD9 license application (Form MD7) via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: A thorough inspection of manufacturing facilities and QMS systems is conducted.
6. Query Resolution: Address any clarifications or deficiencies raised by CDSCO or inspectors.
7. Grant of License: Upon successful compliance, the MD9 Manufacturing License is issued.

Manufacturing License Documents Required

The following documents are mandatory for MD9 license application for your collagen membrane:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership/Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our detailed Device Master File guide can assist in preparation.
• Plant Master File (PMF) describing manufacturing facility and quality control. See our Plant Master File guide for best practices.
• Essential Principles Checklist ensuring compliance with Indian Medical Device Rules
• Risk Management File that addresses hazards and mitigation strategies, crucial for Class C devices. Learn more about Risk Management.
• Test Reports from CDSCO-recognized labs confirming sterility, biocompatibility, and performance
• Product Labels and Instructions for Use (IFU) adhering to regulatory standards
• Quality Management System Documents (ISO 13485:2016 compliant preferred)

Import License Process (MD15)

For importers of collagen dental membranes, an MD15 license is mandatory. The process includes:

1. Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Address any department queries promptly.
4. License Grant: Typically takes 5-6 months.

Fees vary by risk class, with Class C devices incurring INR 3000 per site and INR 1500 per product.

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License: INR 50,000 (application) + INR 1,000 per product
• Test License (MD13): Usually nominal, consult with CDSCO
• Product Testing: Costs vary by laboratory and test scope; budget INR 50,000 - 1,00,000 depending on parameters

For import licenses (MD15), fees are higher, reflecting the central authority's involvement.

Common Challenges and Solutions

Challenge: Delays in test report acquisition due to limited availability of government-approved labs.

Solution: Early engagement with notified testing labs and prioritizing test booking can mitigate delays. Refer to the CDSCO Testing Laboratories List to select recognized labs.

Challenge: Documentation gaps, especially in Device Master File and Risk Management documentation.

Solution: Utilize expert consultancy to prepare or review documents. Our guides on Device Master File and Risk Management ensure compliance with CDSCO expectations.

Challenge: Audit non-compliance due to inadequate Quality Management Systems.

Solution: Implement ISO 13485:2016 aligned QMS early and conduct internal audits before CDSCO inspections.

Expert Consultation and Support

Navigating the MD9 licensing process for a Class C device like the collagen dental regeneration membrane demands precise documentation and strategic planning. Our team offers end-to-end consultancy:

• Gap analysis of existing documentation
• Preparation of Device and Plant Master Files
• Coordination with testing labs
• Audit readiness and mock inspections
• Application submission and follow-up

Our proven track record of 500+ successful CDSCO approvals ensures your project stays on track.

Getting Started with Your CDSCO License Application

1. Assess your device classification and notification status: Confirm your collagen membrane is Class C as per the latest Medical Device Classification.
2. Initiate test license application (MD13): Submit through the CDSCO MD Online Portal.
3. Engage a CDSCO-approved testing laboratory: Book testing slots early to avoid bottlenecks.
4. Prepare comprehensive documentation: Use expert guides and templates to complete your DMF, PMF, Risk Management, and QMS files.
5. Apply for MD9 manufacturing license: After receiving satisfactory test reports, submit Form MD7 online.
6. Prepare for audit: Ensure all manufacturing processes and documentation are inspection-ready.
7. Respond promptly to CDSCO queries: Expedite approvals by timely clarifications.

Embarking on this journey with expert guidance not only accelerates your license grant but also positions your collagen dental regeneration membrane for sustained market success in India.

For tailored support and to leverage our extensive experience, contact us to streamline your CDSCO licensing process effectively.