CDSCO License for Dental excavator, reusable

Introduction to Dental Excavator (Reusable) and Its Regulatory Importance

Dental excavators are essential reusable instruments used by dental professionals to cut, clean out, and shape carious cavities before filling. As a Class A medical device under Indian regulations, the dental excavator is considered low risk but still requires compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework to ensure safety and quality in the Indian market.

With over 25 years of expertise and having assisted more than 500 manufacturers and importers, we understand the nuances involved in navigating the CDSCO licensing process for devices like reusable dental excavators. This comprehensive guide will walk you through the regulatory framework, licensing requirements, timelines, fees, and practical tips specific to your device.

CDSCO Regulatory Framework for Dental Excavators (Reusable)

The CDSCO governs medical devices under the Medical Device Rules (MDR) aligned with the Drugs and Cosmetics Act. Dental excavators fall under the dental category and are notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Being a Class A device, licensing is managed by the State Licensing Authority with oversight from CDSCO.

Manufacturers of reusable dental excavators must obtain an MD5 manufacturing license (application Form MD3), while importers require the MD15 import license.

Risk Classification and License Requirements for Dental Excavators

As a Class A device, the reusable dental excavator is categorized as low risk. The classification impacts the licensing pathway:

• Manufacturing License: MD5 License issued by the State Licensing Authority.
• Import License: MD15 License issued by CDSCO Central Licensing Authority.

For Class A devices, the entire manufacturing license process, including test licenses, testing, and audits, typically takes 3 to 4 months.

You can verify your device classification and associated regulatory requirements on our detailed Medical Device Classification guide.

Manufacturing License Process for Dental Excavators (MD5 License)

The MD5 manufacturing license process for dental excavators involves the following key steps:

1. Obtain Test License (Form MD13): The first step is securing a test license for your products, which takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved laboratories. For dental excavators, mechanical and biocompatibility parameters are typically tested. Refer to the list of Testing Laboratories approved by CDSCO.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, risk management files, labels, and Instructions for Use (IFU).
4. Application Submission: Submit your manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by a notified body is mandatory for Class A devices. You can find the list of approved bodies on the Notified Bodies List.
6. Queries Resolution: Address any queries from the licensing authority or notified body promptly.
7. License Grant: Upon successful review and audit, the MD5 manufacturing license is granted (Form MD5).

Manufacturing License Documents Required for Dental Excavators

To ensure a smooth application process for your reusable dental excavator manufacturing license, prepare the following documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Comprehensive Device Master File (DMF) detailing design, specifications, and manufacturing process. Our Device Master File guide can assist.
• Plant Master File (PMF) documenting manufacturing facilities and processes. Refer to our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File showcasing hazard identification and mitigation strategies. Learn more about Risk Management.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process for Dental Excavators (MD15 License)

If you are an importer of reusable dental excavators, obtaining an MD15 import license from the CDSCO Central Licensing Authority is mandatory. The process includes:

1. Document Preparation: Assemble all required import license documents.
2. Application Submission: Submit Form MD14 application via the CDSCO MD Online Portal.
3. Queries Resolution: Address any queries raised by CDSCO.
4. License Issuance: Upon successful evaluation, the MD15 import license is granted.

Notably, no test license is required for import licenses.

Import License Documents Required for Dental Excavators

The following documents must be submitted for an MD15 import license:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Planning your application timeline with these durations in mind is critical to avoid market entry delays.

Government Fees and Costs Associated

For your reusable dental excavator (Class A device), the fee structure is as follows:

• MD5 Manufacturing License:

  • Application Fee: INR 5,000
  • Per Product Fee: INR 500

• MD15 Import License:

  • Application Fee: Approximately USD 1,000 per site
  • Per Product Fee: USD 50

These fees are payable via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

Challenge 1: Delayed Testing Results

• Solution: Engage early with CDSCO-approved testing laboratories and schedule testing promptly after receiving the test license.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use comprehensive checklists and professional consultation to ensure all documents meet CDSCO standards.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits before notified body inspections to identify gaps.

Challenge 4: Misclassification Risks

• Solution: Verify device classification using official guides and consult experts to avoid application rejections.

Expert Consultation and Support

With our extensive experience guiding over 500 companies through successful CDSCO licensing, we offer tailored consulting services to streamline your dental excavator registration. Our expertise includes document preparation, audit readiness, regulatory strategy, and liaison with authorities to minimize processing time.

Getting Started with Your CDSCO License Application for Reusable Dental Excavators

1. Assess Your Device Classification: Confirm your device is Class A and review associated requirements.
2. Prepare Test License Application: Submit Form MD13 via CDSCO MD Online Portal to start testing.
3. Schedule Product Testing: Coordinate with government-approved labs to conduct necessary tests.
4. Assemble Required Documents: Use our Device and Plant Master File guides to prepare detailed dossiers.
5. Apply for Manufacturing License: Submit Form MD3 application on the portal.
6. Arrange Audit: Coordinate with notified bodies for your facility audit.
7. Respond to Queries Promptly: Maintain open communication with licensing authorities.

By following these actionable steps and leveraging professional regulatory support, you can efficiently secure your CDSCO license and launch your reusable dental excavator in India’s growing dental market.

For more detailed guidance, explore our comprehensive MD5 License Guide and reach out to our experts for personalized assistance.