CDSCO License for Pliable-polymer dental regeneration membrane, bio absorbable, ligated
Medical Device Information
Intended Use
A sterile bio absorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period.
Comprehensive Guide to CDSCO Licensing for Pliable-Polymer Dental Regeneration Membranes (Class C)
Navigating the regulatory landscape for medical devices in India can be complex, especially for advanced products like pliable-polymer dental regeneration membranes that are bio-absorbable and ligated. These devices, designed to aid in periodontal regeneration by preventing soft tissue down-growth, fall under Class C according to CDSCO’s risk classification. With over 25 years of experience assisting 500+ manufacturers and importers, we provide a detailed, actionable roadmap for securing your CDSCO license for this specific dental device.
CDSCO Regulatory Framework for Class C Dental Devices
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India under the Medical Device Rules, 2017. Your pliable-polymer dental regeneration membrane is classified as a Class C medical device, indicating a moderate to high risk due to its intended use in human tissue regeneration.
Regulation of Class C devices involves stringent scrutiny by the Central Licensing Authority, ensuring safety, efficacy, and quality before market entry. Your device is notified under the notification number 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, which specifically covers dental regenerative materials.
Risk Classification and License Requirements for Your Device
Class C medical devices require an MD9 manufacturing license granted by the Central Licensing Authority (CDSCO). The MD9 license process is comprehensive, including product testing, documentation review, and a factory audit.
For importers, the corresponding license is the MD15 import license, also issued by the Central Licensing Authority. Both pathways demand strict compliance with Indian regulations, including adherence to ISO 13485:2016 standards and demonstration of product safety and performance.
Manufacturing License Process (MD9) for Class C Dental Membranes
Obtaining an MD9 license involves multiple steps:
Test License (Form MD13): Initially, you must apply for a test license, which takes approximately 1.5 to 2 months. This permits product testing in CDSCO-approved laboratories.
Product Testing: Conduct all required tests in government-approved labs. For your dental membrane, biocompatibility, sterility, and absorbability tests are critical. Refer to the current Testing Laboratories list for approved facilities.
Document Preparation: Assemble a comprehensive dossier including the Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents. Our detailed Device Master File guide can help streamline this process.
License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal once testing is complete.
Inspection and Audit: CDSCO inspectors conduct an on-site audit assessing manufacturing premises, technical staff qualifications, documentation, and QMS compliance.
Query Resolution: Address any observations or queries raised by CDSCO during the audit.
Grant of License (Form MD9): Upon satisfactory compliance, the license is granted.
Manufacturing License Documents Required for MD9
For your pliable-polymer dental regeneration membrane, the following documents are mandatory:
- Company Constitution and Registration Proof
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire Safety NOC and Pollution Control NOC
- Device Master File detailing design, manufacturing process, and specifications
- Plant Master File outlining the manufacturing facility and quality controls
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File demonstrating hazard analysis and mitigation
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Class C Dental Devices
If you plan to import your dental membrane:
Document Compilation: Prepare your dossier including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
License Application (Form MD14): Submit your MD15 import license application via the CDSCO MD Online Portal.
Queries and Review: Respond promptly to any CDSCO queries.
License Grant: The MD15 license is typically granted within 5-6 months.
Timeline and Processing Duration
MD9 Manufacturing License: Approximately 4-5 months total.
- Test License (MD13): 1.5-2 months
- Product Testing: 3-4 weeks
- Document Preparation: Concurrent with testing
- Application Review and Audit: 2-3 months
MD15 Import License: 5-6 months
Understanding this timeline helps you plan product launch and resource allocation effectively.
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: Rs 50,000
- Per Product Fee: Rs 1,000
MD15 Import License:
- For Class C & D devices, the site fee is USD 3,000 and product fee is USD 1,500 per product
These fees are payable through the CDSCO portal and are non-refundable.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with notified testing laboratories and prioritize sample submission. Regular follow-ups can accelerate turnaround times.
Challenge 2: Documentation Gaps
- Solution: Use checklists from authoritative sources like our Plant Master File guide to ensure completeness.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits and train your technical staff on regulatory requirements beforehand.
Challenge 4: Query Resolution Delays
- Solution: Prepare prompt and comprehensive responses with supporting evidence to avoid prolonged back-and-forth.
Expert Consultation and Support
Leveraging expert guidance significantly improves your chances of a successful application. With our 25+ years of experience and over 500 successful CDSCO licenses, we provide:
- Customized document preparation assistance
- Coordination with testing laboratories and notified bodies
- Pre-audit readiness assessments
- Complete application submission and follow-up services
Getting Started with Your CDSCO License Application
Evaluate your Device Classification: Confirm your device is Class C using the official Medical Device Classification tool.
Register on the CDSCO MD Online Portal: Create your account to access application forms and track your submission.
Arrange for Product Testing: Identify and contact CDSCO-approved testing laboratories early.
Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
Consult with Experts: Engage regulatory consultants to verify your dossier and audit readiness.
Submit Test License Application (MD13): Initiate the formal process by applying for the test license.
By following these steps and leveraging our expertise, your pliable-polymer dental regeneration membrane can achieve regulatory approval efficiently, enabling you to confidently enter the Indian dental device market.
For personalized assistance and detailed consultation, reach out to us today and benefit from our proven track record in CDSCO licensing.
