CDSCO License for Dappen dish, single-use

Comprehensive Guide to CDSCO Licensing for Single-Use Dappen Dish (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience aiding 500+ medical device manufacturers and importers, we understand the intricacies of securing CDSCO licenses in India. This guide focuses on the single-use Dappen dish, a Class A dental device used for kneading and holding dental materials. We provide you with practical insights, timelines, costs, and documentation specifics to streamline your licensing journey under the CDSCO framework.

Understanding the Dappen Dish and its Regulatory Importance

The single-use Dappen dish is a small, shallow concave vessel essential in dental procedures for handling materials safely and hygienically. Given its direct contact with dental substances, regulatory compliance ensures patient safety and quality assurance. As per the CDSCO notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, this device falls under Class A, the lowest risk category but still requires mandatory registration and licensing before market entry.

CDSCO Regulatory Framework for Class A Dental Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For Class A devices like the Dappen dish, licensing authority rests with the State Licensing Authority under the MD5 license category. This classification is based on risk assessment, and compliance involves adherence to quality standards, Good Manufacturing Practices (GMP), and submission of comprehensive technical documentation.

Risk Classification and License Requirements for Single-Use Dappen Dish

Risk Class: A (Low risk)
License Type: MD5 Manufacturing License
Applicable Forms:
- Test License: Form MD13 (mandatory before full license application)
- Manufacturing License Application: Form MD3
- License Issuance: Form MD5

Detailed Manufacturing License Process (MD5) for Dappen Dish

Obtain Test License (Form MD13): Apply through the CDSCO MD Online Portal to get a test license, which allows you to manufacture limited quantities for testing purposes. This step typically takes 1.5 to 2 months.
Product Testing: Submit product samples to CDSCO-approved laboratories. Testing verifies compliance with Essential Principles and safety standards. Refer to the list of testing laboratories for approved facilities.
Compile Technical Documentation: Prepare comprehensive dossiers including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, QMS documents, and more.
Apply for Manufacturing License (Form MD3): Once testing is complete and documentation is ready, submit your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: The state authority will arrange an audit by a notified body. Check the list of notified bodies to select an auditor suitable for your region and device.
Resolve Queries: Address any observations or queries raised during audit or by the licensing authority promptly to avoid delays.
License Grant (Form MD5): Upon satisfactory review and audit clearance, your MD5 license will be issued for manufacturing the single-use Dappen dish.

Essential Documents Required for MD5 License Application

Company Constitution and Incorporation Certificates
Proof of Premises Ownership or Lease Agreement
Details and Qualifications of Technical Staff
Fire NOC and Pollution Control Board Clearance
Device Master File (DMF): Detailed design, manufacturing process, and specifications (comprehensive guide here)
Plant Master File (PMF): Details of manufacturing facility and quality control processes (guide here)
Essential Principles Checklist and Risk Management File (risk management insights)
Test Reports from Government-Approved Labs
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Dappen Dish

If you plan to import the single-use Dappen dish into India, you must obtain an MD15 import license from CDSCO's Central Licensing Authority. The process typically takes 5-6 months and requires:

Manufacturing License of the foreign manufacturer
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate or equivalent
Device Master File and Plant Master File
Wholesale License in India
Company Constitution

Application is submitted via the CDSCO MD Online Portal, using Form MD14. Government fees vary with device class.

Timeline and Processing Duration for MD5 License

Step	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	1 – 1.5 months
Document Preparation	Concurrent with testing
License Application (MD3)	Immediate post-testing
Audit & Queries	1 – 1.5 months
Total Time	3 – 4 months

Government Fees and Cost Structure

Application Fee: Rs. 5,000 per application
Product Fee: Rs. 500 per product (for Dappen dish, single SKU, Rs. 500)
Notified Body Audit Fees: Variable, typically Rs. 50,000 – Rs. 1,00,000 depending on auditor
Testing Laboratory Fees: Rs. 20,000 – Rs. 50,000 depending on tests

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to backlog at government labs.
Solution: Plan sample submission early and consider private labs accredited by CDSCO.
Challenge: Incomplete documentation leading to audit non-compliance.
Solution: Use detailed checklists and pre-audit mock inspections.
Challenge: Difficulty in selecting notified bodies.
Solution: Refer to the official notified bodies list and choose those with dental device audit experience.
Challenge: Frequent queries on risk management files.
Solution: Implement robust risk management per ISO 14971 and document thoroughly.

Expert Consultation and Support

Navigating CDSCO licensing for Class A devices like the single-use Dappen dish requires expertise. Our consultancy offers:

End-to-end application handling via the CDSCO MD Online Portal
Document preparation and gap analysis
Coordination with notified bodies and testing labs
Post-license compliance support

Getting Started with Your CDSCO License Application

Register on the CDSCO MD Online Portal. Create your manufacturer/importer profile to access application forms.
Prepare your Device and Plant Master Files. Utilize our guides for structured documentation.
Apply for the Test License (Form MD13). This is your gateway to product testing and subsequent license application.
Identify and contact a notified body for the upcoming audit process.
Plan and budget for testing and audit fees upfront to avoid financial surprises.
Compile your QMS and risk management documentation in compliance with CDSCO and ISO standards.

By following this structured approach and leveraging expert support, you can successfully obtain your MD5 manufacturing license for the single-use Dappen dish and confidently enter the Indian dental device market.

For personalized assistance, feel free to reach out to our team of seasoned regulatory consultants.

References and further reading:

CDSCO License for Dappen dish, single-use

Medical Device Information

Important Notice for Class A Devices

Intended Use