CDSCO License for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free
Medical Device Information
Intended Use
An adhesive compound intended to be 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/Polymer Denture Adhesive (Zinc-Free)
As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ companies, we understand the unique challenges faced by manufacturers and importers of dental medical devices like carboxymethylcellulose sodium/polymer denture adhesives. This product, classified as a Class B medical device under the CDSCO framework, requires meticulous adherence to the Indian regulatory guidelines to ensure timely market entry.
Understanding the Device and Its Regulatory Importance
Carboxymethylcellulose sodium/polymer denture adhesive (zinc-free) is intended to stabilize removable dental prostheses by adhering them securely to the oral mucosa. Given its direct contact with mucous membranes, it is categorized under Class B risk, necessitating a moderate regulatory oversight to ensure safety and efficacy.
The regulatory notification governing this device is 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022, emphasizing the latest compliance requirements.
CDSCO Regulatory Framework for Dental Devices Like Denture Adhesives
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, classifying them into four risk classes (A, B, C, D). Dental adhesives fall under Class B, which means manufacturers must obtain an MD5 manufacturing license granted by the State Licensing Authority.
This framework ensures that products meet safety standards through testing, audits, and quality management system (QMS) evaluations before entering the Indian market.
Risk Classification and License Requirements for Class B Devices
Class B devices, including zinc-free polymer denture adhesives, require:
- Test License (Form MD13): Mandatory before manufacturing or import testing.
- MD5 Manufacturing License (Form MD3): Applied to the State Licensing Authority after successful testing and documentation.
- Audit by Notified Body: To verify compliance with manufacturing and quality standards.
This process ensures that all dental adhesives are safe, reliable, and manufactured under a controlled environment.
Manufacturing License Process (MD5) for Carboxymethylcellulose Sodium Denture Adhesive
- Apply for Test License (MD13): The initial step involves obtaining a test license which takes approximately 1.5 to 2 months.
- Product Testing: Conduct product testing at government-approved laboratories listed on the CDSCO Testing Laboratories.
- Prepare Documentation: Compile technical, quality, and compliance documents.
- Apply for MD5 License (MD3): Submit the application through the CDSCO MD Online Portal.
- Notified Body Audit: Engage a notified body from the CDSCO Notified Bodies List to conduct a manufacturing site audit.
- Respond to Queries: Address any queries from the licensing authority or notified body promptly.
- Grant of License (Form MD5): Upon successful completion, the license is issued.
Manufacturing License Documents Required
For the zinc-free polymer denture adhesive, you must prepare the following documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed device specifications and manufacturing process (Device Master File Guide)
- Plant Master File (PMF): Documentation of manufacturing facility (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File tailored to Class B devices (Risk Management Guidance)
- Product Test Reports from Government-Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
Import License Process (MD15) for Dental Adhesives
For importers intending to bring the zinc-free polymer denture adhesive into India, an MD15 Import License is mandatory. This is granted by the Central Licensing Authority and typically takes 5 to 6 months.
Steps include:
- Document Preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016 Certificate, CE Certificate, DMF, PMF, and Wholesale License.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any departmental queries.
- Final grant of the MD15 license.
Import License Documents Required
- Valid Manufacturing License from the Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD5 Manufacturing License | 3 - 4 months total (including test license and audit) |
| MD15 Import License | 5 - 6 months |
From application to license grant, manufacturers should anticipate approximately 3 to 4 months for Class B devices, considering test licenses, audits, and document verification.
Government Fees and Costs
- MD5 License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
- Test License (MD13): Nominal fee as per CDSCO norms
Costs for notified body audits and product testing vary but plan for additional INR 50,000 to 1,00,000 depending on the notified body and lab fees.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all required files, especially DMF and PMF, are comprehensive and accurate to avoid delays.
- Delayed Testing: Schedule testing early with government-approved labs to prevent bottlenecks.
- Audit Non-compliance: Pre-audit internal checks and gap analysis can significantly smooth the notified body inspection.
- Delayed Query Responses: Rapid, precise responses to CDSCO queries reduce processing time.
Our experience shows that proactive planning and expert document preparation can reduce total license procurement time by up to 30%.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be complex, especially for Class B dental adhesives. With over two decades of experience, we offer tailored consultation, document preparation, and liaison services with CDSCO and notified bodies to ensure your application is robust and compliant.
Whether you are setting up manufacturing or importing, our experts guide you through the entire process, including risk management implementation and quality system audits.
Getting Started with Your CDSCO License Application
- Determine Your License Type: For your zinc-free polymer denture adhesive, initiate the process with the MD5 manufacturing license application.
- Register on the CDSCO MD Online Portal: Create your account to access application forms and submission tracking.
- Prepare Test License Application (MD13): Submit early to begin product testing.
- Engage with a Notified Body: Select from the CDSCO Notified Bodies List to plan your audit.
- Compile Your Documentation: Use our Device Master File Guide and Plant Master File Guide to ensure completeness.
- Consult with Experts: Leverage our experience for pre-submission review to avoid common pitfalls.
By following these actionable steps, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely market access and regulatory compliance for your dental adhesive product.
For personalized assistance or to start your application process, contact us today and benefit from our proven expertise in CDSCO medical device licensing.
