CDSCO License for Dappen dish, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Dappen Dish (Class A Medical Device)

As specialists with over 25 years of experience supporting 500+ medical device manufacturers and importers, we understand the regulatory nuances involved in bringing devices like the reusable Dappen dish to the Indian market. This small but essential dental device, used for mixing and holding dental materials, falls under the Class A risk category, governed by CDSCO’s specific frameworks. Navigating India’s regulatory environment is critical to ensure compliance, avoid delays, and successfully launch your product.

CDSCO Regulatory Framework for Reusable Dappen Dish

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017, amended periodically. The reusable Dappen dish is notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, categorizing it as a Class A medical device under Dental devices.

Class A devices are considered low risk. Their manufacturing licenses are issued by the State Licensing Authority via the MD5 license route using Form MD3.

Risk Classification and License Requirements for Dappen Dish

• Device Name: Reusable Dappen dish
• Intended Use: Mixing and holding dental materials
• Category: Dental
• Risk Class: A (Low risk)
• Applicable License: MD5 Manufacturing License (Form MD3)

Class A classification simplifies the regulatory process but still requires strict adherence to CDSCO guidelines including quality management systems and documentation.

Manufacturing License Process for Class A Devices (MD5 License)

1. Test License (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license allowing product testing. This usually takes 1.5 to 2 months.

2. Product Testing: Conduct testing at CDSCO-approved government laboratories. For reusable Dappen dishes, testing focuses on material safety, biocompatibility, and compliance with essential principles.

3. Documentation Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit to verify compliance. You can check the list of notified bodies authorized for MD5 audits.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon successful audit and document review, the State Licensing Authority grants the MD5 license using Form MD5.

Manufacturing License Documents Required

For your reusable Dappen dish manufacturing license application, ensure you compile the following:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, specifications, and manufacturing processes (see our guide)
• Plant Master File describing facilities and equipment (learn more)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (risk management insights)
• Test Reports from CDSCO-approved labs (testing labs list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process (MD15) for Reusable Dappen Dishes

For importers, the MD15 license issued by the Central Licensing Authority is mandatory. The process includes:

• Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485, CE Certificate, and other regulatory documents.
• Application submission on the CDSCO MD Online Portal.
• Query resolution and license grant.

The process typically takes 5-6 months, with fees varying based on product classification.

Timeline and Processing Duration

Government Fees and Costs

• Test License Fee (MD13): Included in application process
• MD5 License Fee: Rs 5,000 per application + Rs 500 per product

For example, if you apply for manufacturing of reusable Dappen dish only, the total fee will be Rs 5,500.

Common Challenges and Solutions

• Delayed Testing Results: Plan early and coordinate with CDSCO-approved labs well in advance.
• Incomplete Documentation: Use detailed checklists and expert consultations to ensure all documents, including risk management and master files, are comprehensive.
• Audit Non-compliance: Conduct internal audits and pre-assessments to prepare for notified body inspection.
• Query Delays: Respond promptly and clearly to authority queries to avoid process bottlenecks.

Expert Consultation and Support

With extensive experience assisting over 500 companies, we offer tailored consultancy services including:

• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application drafting and submission on the CDSCO MD Online Portal
• Audit readiness and QMS implementation

Our practical knowledge ensures smoother application processes and faster license grants.

Getting Started with Your CDSCO License Application for Reusable Dappen Dish

1. Verify Classification: Confirm your reusable Dappen dish as Class A under the latest CDSCO notifications.
2. Plan Your Testing: Identify CDSCO-approved labs early and apply for the test license (MD13).
3. Prepare Documentation: Compile detailed Device Master File, Plant Master File, and risk management data.
4. Submit Application: Use the online portal to submit Form MD3 for the MD5 manufacturing license.
5. Schedule Audit: Coordinate with a notified body for your on-site audit.
6. Engage with Authorities: Proactively manage queries and document requests.

Starting early and leveraging expert guidance can reduce your timeline significantly. To learn more about the MD5 license process, visit our detailed MD5 License Guide.

Embarking on your regulatory journey with confidence ensures your reusable Dappen dish reaches the Indian dental market efficiently and compliantly.