CDSCO License for Carboxymethylcellulose sodium denture adhesive
Medical Device Information
Intended Use
An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth.
Comprehensive Guide to CDSCO Licensing for Carboxymethylcellulose Sodium Denture Adhesive (Class B Dental Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like Carboxymethylcellulose sodium denture adhesive. This device, classified under Risk Class B, is intended to stabilize removable dental prostheses by adhering them to the oral mucosa. As experts with over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we provide a detailed roadmap to help you successfully register your product and enter the Indian market.
Understanding the CDSCO Regulatory Framework for Dental Devices
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Ministry of Health & Family Welfare. Dental devices like Carboxymethylcellulose sodium denture adhesive fall under notified medical devices, specifically referenced in Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
This adhesive is categorized as a Class B device, meaning it has a low to moderate risk profile. Consequently, it requires compliance with the MD5 manufacturing license pathway granted by the State Licensing Authority.
Risk Classification and License Requirements for Carboxymethylcellulose Sodium Denture Adhesive
- Risk Class: B (Low to Moderate Risk)
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Regulatory Authority: State Licensing Authority
- Applicable Forms: MD3 (Application for MD5), MD13 (Test License)
You can verify your device classification on the Medical Device Classification guide.
Manufacturing License Process (MD5) for Class B Dental Devices
The MD5 license process is multi-phased and typically takes 3 to 4 months from start to finish. Here's a step-by-step overview:
Test License Application (Form MD13): Before manufacturing, obtain a Test License. This takes approximately 1.5 to 2 months.
Product Testing: Submit your denture adhesive samples to government-approved laboratories listed on the CDSCO Testing Laboratories page for evaluation against standards.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
Filing the MD5 Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will coordinate an audit conducted by a notified body. You can check the list of notified bodies here.
Resolution of Queries: Address any observations or queries raised by the auditors or licensing authority promptly.
Grant of MD5 License: Upon successful compliance, the license is granted on Form MD5.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following key documents:
- Company Constitution: Certificate of incorporation, partnership deed, or LLP agreement.
- Proof of Ownership or Lease of Manufacturing Premises: Property documents or rental agreements.
- Technical Staff Credentials: Qualification certificates of key personnel involved in manufacturing.
- No Objection Certificates (NOCs): Fire safety and pollution control clearances.
- Device Master File: Detailed product specifications, formulation, and manufacturing process. Refer to our Device Master File guide.
- Plant Master File: Details of manufacturing facility, equipment, and hygiene practices (Plant Master File Guide).
- Essential Principles Checklist: Compliance checklist with Indian Medical Device Rules.
- Risk Management File: Documentation of risk analysis and mitigation strategies (Risk Management Insights).
- Test Reports: Certificates from approved laboratories confirming product safety and efficacy.
- Labels and Instructions for Use (IFU): Sample labels, packaging, and user instructions.
- Quality Management System (QMS) Documents: ISO 13485 certification and internal audit reports.
Import License Process (MD15) for Carboxymethylcellulose Sodium Denture Adhesive
If you plan to import this device into India, an MD15 import license is mandatory and issued by the Central Licensing Authority. The process typically spans 5 to 6 months and involves:
- Document preparation including manufacturing license, Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files.
- Application submission via Form MD14 on the CDSCO MD Online Portal.
- Query resolution and compliance verification.
- License grant on Form MD15.
Refer to our detailed Import License Guide for comprehensive steps.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | Concurrent with testing |
| MD5 Application Processing | 1 – 1.5 months |
| Audit & Query Resolution | 3 – 4 weeks |
| Total Duration | 3 – 4 months |
Government Fees and Costs
- MD5 License Application Fee: Rs 5,000 per application.
- Product Fee: Rs 500 per product.
Note: Costs exclude expenses for product testing, notified body audits, and consultant fees.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage government-approved labs early and prepare samples meticulously to avoid retesting.
Challenge 2: Incomplete Documentation
- Solution: Utilize our checklists for Device Master File and Plant Master File to ensure completeness.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal mock audits to identify gaps before notified body inspections.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory liaison to respond promptly to authority queries.
Expert Consultation and Support
With our 25+ years of regulatory expertise, we have guided over 500 manufacturers and importers to a successful CDSCO license grant. Our services include:
- Gap analysis of existing documentation
- Device Master and Plant Master File preparation
- Coordination with notified bodies and testing labs
- End-to-end application submission and follow-up
Getting Started with Your CDSCO License Application
Confirm Device Classification: Use official CDSCO resources or consult our classification guide.
Register on the CDSCO MD Online Portal: Begin by creating your account at the CDSCO MD Online Portal.
Prepare Test License Application: Gather required documents and apply for the MD13 test license.
Initiate Product Testing: Arrange for sample testing at approved labs.
Compile Complete Documentation: Refer to our guides for Device Master File and Plant Master File.
Submit MD5 Application: Once test reports are in hand, apply on the portal.
Prepare for Audit: Implement QMS and conduct internal audits to ensure compliance.
Engage Expert Support: Reach out to experienced consultants to streamline the process and avoid common pitfalls.
By following this structured approach, manufacturers and importers of Carboxymethylcellulose sodium denture adhesive can efficiently navigate the CDSCO regulatory process and bring their products to the Indian market with confidence.
For detailed assistance, contact us to leverage our extensive expertise in medical device licensing in India.
