CDSCO License for Dental Etchant

Comprehensive Guide to CDSCO Licensing for Dental Etchant (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like Dental Etchant. As a material designed for temporary etching of dental hard tissue to condition surfaces for bonding procedures, Dental Etchant falls under the dental category and is classified as a Class B medical device under the CDSCO framework. With over 25 years of experience and having supported 500+ companies in securing CDSCO approvals, we provide you with a detailed, practical roadmap to obtaining your manufacturing license (MD5) for this device.

Understanding the CDSCO Regulatory Framework for Dental Etchant

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India to ensure safety, quality, and efficacy. Dental Etchant is notified under the Medical Device Rules, 2017, and specifically under notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Being a Class B device, it requires a state-level MD5 manufacturing license.

Risk Classification and License Requirements for Dental Etchant

Risk Class: B (Low-moderate risk)
License Type: MD5 Manufacturing License
Regulatory Authority: State Licensing Authority

Class B devices like Dental Etchant require adherence to quality systems and must undergo product testing and audit by a notified body before license issuance.

Manufacturing License Process (MD5) for Dental Etchant

The entire MD5 licensing process typically spans 3 to 4 months and involves the following key steps:

Test License (Form MD13): Apply for a test license to legally manufacture samples for testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Submit Dental Etchant samples to CDSCO-approved testing laboratories for evaluation. Select from the list of government-approved testing labs to ensure compliance with the Essential Principles.
Documentation Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: File the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed here, to verify compliance with manufacturing practices and quality requirements.
Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
Grant of License: Upon successful completion of audits and document compliance, the MD5 license is granted via Form MD5.

For a stepwise guide, our MD5 License Guide offers in-depth insights.

Manufacturing License Documents Required for Dental Etchant

Prepare the following documents to ensure a smooth application process:

Company Constitution: Incorporation certificates, Memorandum & Articles of Association.
Proof of Premises Ownership: Rent agreement or sale deed.
Technical Staff Details: CVs and qualifications of key personnel.
Fire and Pollution NOCs: No Objection Certificates from relevant authorities.
Device Master File: Detailed product specifications, design, and manufacturing process. Refer to our Device Master File guide for preparation tips.
Plant Master File: Documentation of manufacturing facility and equipment. Our Plant Master File guide can assist you.
Essential Principles Checklist: Compliance matrix aligning with regulatory standards.
Risk Management File: Comprehensive risk assessment and mitigation strategies following ISO 14971. Learn more about risk management here.
Test Reports: Certificates from government-approved labs validating product safety and performance.
Labels and Instructions for Use (IFU): Drafts complying with CDSCO labeling requirements.
Quality Management System Documents: ISO 13485 certification and internal SOPs.

Import License Process (MD15) for Dental Etchant

If you're importing Dental Etchant into India, an MD15 import license from CDSCO's central authority is mandatory. The process involves:

Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certification, Device Master File, and wholesale license.
Submission of application on Form MD14 through the CDSCO MD Online Portal.
Resolution of queries during evaluation.
Grant of MD15 license within approximately 5-6 months.

For detailed steps, please consult our Import License Guide.

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 Drug License
Company Constitution Documents

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 - 2 months
Product Testing	3 - 4 weeks
Document Preparation	3 - 4 weeks
Application Review	4 - 6 weeks
Audit by Notified Body	3 - 4 weeks
Query Resolution	2 - 3 weeks
Total Duration	3 - 4 months

Government Fees and Costs for Dental Etchant (Class B)

Test License (MD13): Included in application
MD5 License Fees: Rs. 5,000 per application + Rs. 500 per product

Example: For a single Dental Etchant product, the total fee would be Rs. 5,500.

Additional costs may include:

Testing lab charges (varies by lab and product complexity)
Notified body audit fees
Consultancy fees if you engage experts

Common Challenges and Practical Solutions

Delayed Test Reports: Choose accredited and reliable testing labs early to avoid bottlenecks.
Incomplete Documentation: Use detailed checklists and templates from experienced consultants.
Audit Non-Compliance: Conduct internal pre-audit reviews to ensure readiness.
Query Resolution Delays: Respond promptly and comprehensively to avoid application rejection.

Expert Consultation and Support

With over two decades of experience, we have helped 500+ companies successfully navigate CDSCO licensing. Our tailored services include:

Preparation of Device and Plant Master Files
Risk Management File development
Coordination with notified bodies and testing labs
End-to-end application filing and follow-up

Getting Started with Your CDSCO License Application for Dental Etchant

Assess Classification: Confirm your device is Class B as per CDSCO guidelines.
Engage Testing Laboratory: Identify and communicate with a CDSCO-approved testing lab.
Prepare Documentation: Begin compiling all required files using expert templates.
Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to start manufacturing samples for testing.
Schedule Product Testing: Coordinate sample submission and testing timelines.
Plan Audit: Contact a notified body early from the official list to schedule your audit.

Starting early and following a structured plan will help you secure your MD5 license efficiently, enabling you to bring your Dental Etchant to the Indian market compliantly and swiftly.

For personalized assistance, reach out to our expert team to streamline your CDSCO licensing journey.

CDSCO License for Dental Etchant

Medical Device Information

Intended Use