CDSCO License for Dental material mixing surface, reusable

Comprehensive Guide to CDSCO Licensing for Dental Material Mixing Surface (Reusable) Devices

As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies in securing CDSCO licenses, we understand the nuances involved in registering medical devices in India. This guide focuses on the Dental Material Mixing Surface, Reusable—a Class A dental device used as a slab or tray for mixing dental materials—classified under notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.

Understanding the Regulatory Importance of CDSCO Licensing for Dental Devices

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India to ensure safety, quality, and efficacy. For Class A dental devices like the reusable dental material mixing surface, acquiring the appropriate manufacturing license (MD5) is mandatory before market entry. This not only complies with Indian regulations but also builds trust with healthcare professionals and end-users.

CDSCO Regulatory Framework for Dental Material Mixing Surface Devices

Under the Medical Device Rules 2017, devices are categorized based on risk classification. The dental material mixing surface is a low-risk Class A device, regulated primarily at the State Licensing Authority level. The licensing process comprises:

• Obtaining a Test License (Form MD13)
• Product testing at CDSCO-approved laboratories
• Submission of manufacturing license application (Form MD3) for MD5 License
• Audit by a notified body
• Resolution of any queries raised by authorities

You can submit all applications conveniently through the CDSCO MD Online Portal.

Risk Classification and License Requirements for This Device

• Device Class: A (Low Risk)
• License Type: MD5 (Manufacturing license for Class A and B devices)
• Regulatory Body: State Licensing Authority
• Notification Reference: 29/Misc./03/2020-DC (140) Part-5
• Typical Timeline: 3-4 months total

For more details on medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Dental Material Mixing Surface

1. Test License Application (Form MD13): Initiate by applying for a test license, allowing product testing from government-approved labs. This step takes approximately 1.5 to 2 months.

2. Product Testing: Get the dental material mixing surface tested at CDSCO-approved testing laboratories to validate compliance with essential principles. You can find the list of approved testing labs here.

3. Document Preparation: Assemble all prerequisite documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, risk assessment files, and labeling materials.

4. License Application (Form MD3): Submit the manufacturing license application for MD5 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an on-site audit to verify compliance with regulatory requirements. You can check the list of notified bodies for audit here.

6. Query Resolution: Address any clarifications or queries raised by the CDSCO or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and document verification, your manufacturing license will be granted.

For an in-depth understanding of this process, our MD5 License Guide provides valuable insights.

Manufacturing License Documents Required

To streamline your application, ensure the following documents are prepared and compliant:

• Company Constitution: Incorporation certificate, partnership deed, or other proof.
• Proof of Ownership or Lease of Premises: Valid property documents for manufacturing site.
• Technical Staff Qualifications: Details and credentials of qualified personnel.
• Fire and Pollution NOCs: No objection certificates from local authorities.
• Device Master File (DMF): Detailed device specifications, manufacturing process, and design control. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of manufacturing facilities and equipment. Visit our Plant Master File guide for templates.
• Essential Principles Checklist: Compliance with Indian medical device essential principles.
• Risk Management File: Hazard analysis and risk mitigation strategies. Explore our Risk Management guide.
• Test Reports: Validated test reports from CDSCO-approved labs.
• Labels and Instructions for Use (IFU): Device labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs.

Import License Process (MD15) – Relevant for Importers

While this guide primarily addresses manufacturers, importers of dental material mixing surfaces must obtain an MD15 import license from the Central Licensing Authority. The process involves:

• Document compilation including manufacturing license from country of origin, ISO 13485, Free Sale Certificate, CE certificate
• Application submission on the CDSCO MD Online Portal
• Resolution of any queries
• License grant typically within 5-6 months

For detailed guidance, see our Import License Guide.

Timeline and Processing Duration for MD5 License

Total Approximate Time: 3 to 4 months

Government Fees and Costs

• Test License Fee: Included in application
• MD5 Manufacturing License Fees:
  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

Additional Costs:

• Testing laboratory fees (varies per test)
• Notified body audit fees (depends on body and scope)
• Consultant fees if engaging expert support

Common Challenges and Practical Solutions

• Incomplete Documentation: Prepare checklists and perform internal audits before submission.
• Delayed Testing: Schedule lab tests early and choose labs based on capacity.
• Audit Non-conformities: Conduct mock audits and rectify discrepancies proactively.
• Query Resolution Delays: Assign dedicated personnel to respond promptly to CDSCO communications.

Expert Consultation and Support

With over two decades of hands-on experience, we have streamlined CDSCO licensing for hundreds of dental device manufacturers and importers. Our services include:

• End-to-end license application support
• Document preparation and review
• Coordination with notified bodies and testing labs
• Mock audits and training

Reach out early to navigate the complex regulatory landscape efficiently.

Getting Started with Your CDSCO License Application for Dental Material Mixing Surface

1. Verify Your Device Classification: Confirm your device falls under Class A using official notifications.
2. Prepare Your Test License Application: Gather preliminary documents and apply for Form MD13 via the CDSCO MD Online Portal.
3. Engage Approved Testing Laboratories: Schedule product testing immediately after test license approval.
4. Compile Required Documentation: Use our guides for Device Master File and Plant Master File to ensure completeness.
5. Schedule Notified Body Audit: Coordinate with notified bodies early to avoid scheduling bottlenecks.
6. Submit Manufacturing License Application: Apply for MD5 license (Form MD3) through the online portal.

By following these actionable steps and leveraging expert guidance, manufacturers of dental material mixing surfaces can achieve timely CDSCO license approval, ensuring compliance and smooth market entry.

For further assistance, consult our detailed MD5 License Guide or contact our regulatory experts today.