CDSCO License for Ceramic artificial teeth

Comprehensive Guide to CDSCO Licensing for Ceramic Artificial Teeth (Class B)

Ceramic artificial teeth play a crucial role in dental prosthetics, serving as prefabricated ceramic (porcelain) components for removable or fixed partial dentures. As a Class B medical device under the CDSCO framework, these dental devices require a specific regulatory pathway to ensure safety, quality, and compliance with Indian medical device regulations.

With over 25 years of expertise and having assisted 500+ companies in obtaining CDSCO licenses, we provide a detailed, practical roadmap for manufacturers and importers of ceramic artificial teeth to navigate the licensing process seamlessly.

CDSCO Regulatory Framework for Ceramic Artificial Teeth

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Ceramic artificial teeth fall under the dental category and are notified under the Gazette Notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022.

Under the Medical Device Rules (MDR) 2017, ceramic artificial teeth are classified as Class B devices based on their moderate risk profile. This classification determines the licensing authority and procedural requirements.

Risk Classification and License Requirements for Ceramic Artificial Teeth

• Risk Class: B (Moderate Risk)
• Licensing Authority: State Licensing Authority
• Required License: MD5 Manufacturing License (Application Form MD3)
• Notification: 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022

Since the device is Class B, manufacturers must obtain the MD5 license, which involves submitting an application to the State Licensing Authority, performing product testing, and undergoing an audit by a notified body.

Manufacturing License Process (MD5) for Ceramic Artificial Teeth

1. Test License Application (Form MD13): Begin with obtaining a test license to allow product testing. This typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate compliance with applicable standards. Refer to the list of testing laboratories for authorized facilities.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, Quality Management System (QMS) documentation, and risk management files.
4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body listed on the official notified bodies list will conduct a comprehensive audit of manufacturing premises and quality systems.
6. Query Resolution: Address any queries or deficiencies raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful audit and documentation review, the State Licensing Authority will issue the MD5 manufacturing license.

Manufacturing License Documents Required for Ceramic Artificial Teeth

To streamline your application, prepare the following essential documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control Board Clearance
• Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation. Our Device Master File guide can assist you.
• Plant Master File (PMF): Details of manufacturing facilities and equipment. Learn more in our Plant Master File guide.
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File demonstrating risk assessments and mitigation strategies (Risk Management guide)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Ceramic Artificial Teeth

For importers, the applicable license is the MD15 import license, issued by the Central Licensing Authority. The process is more document-intensive and takes approximately 5 to 6 months.

Steps include:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license.
• Submit application using Form MD14 via the CDSCO MD Online Portal.
• Address queries from CDSCO during the review.
• Receive the MD15 import license.

Refer to our detailed Import License Guide for tailored assistance.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority of the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if marketed in the European Union)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Planning ahead and aligning all documentation and testing in parallel can optimize this timeline.

Government Fees and Costs

• Test License (MD13): Included in MD5 process, fees vary by state.
• MD5 Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs to consider:

• Testing laboratory fees (vary by test scope and lab)
• Consultancy fees if opting for expert assistance
• Costs for audits by notified bodies

Common Challenges and Solutions

• Challenge: Delays in product testing due to backlog at government labs.

  • Solution: Schedule testing early and consider private accredited labs where permitted.

• Challenge: Incomplete documentation leading to application rejection or queries.

  • Solution: Utilize checklists and expert review before submission. Our Device and Plant Master File guides can ensure completeness.

• Challenge: Audit non-compliance due to inadequate QMS or facility issues.

  • Solution: Conduct internal audits and pre-assessments. Engage notified bodies early for guidance.

• Challenge: Confusion over classification and applicable license type.

  • Solution: Refer to the official medical device classification resources or consult experts.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially with evolving regulations. Leveraging over 25 years of regulatory expertise, we provide:

• Comprehensive documentation preparation
• Pre-audit readiness assessments
• Liaison with CDSCO and notified bodies
• Customized project timelines and cost estimations

Our proven track record with 500+ successful client licenses ensures your compliance journey is smooth and efficient.

Getting Started with Your CDSCO License Application for Ceramic Artificial Teeth

1. Assess Your Product Classification: Confirm your device is Class B under the notified dental device list.
2. Initiate Test License Application: Apply for the MD13 test license through the CDSCO MD Online Portal.
3. Arrange Product Testing: Coordinate with CDSCO-approved testing laboratories early.
4. Prepare Documentation: Start compiling your Device Master File, Plant Master File, and QMS documents.
5. Plan for Audit: Engage a notified body from the official list to understand audit requirements.
6. Submit MD5 License Application: Once test license and product testing are complete, submit Form MD3 on the CDSCO portal.
7. Respond Promptly to Queries: Address any regulatory queries swiftly to avoid delays.

By following these precise steps, manufacturers and importers of ceramic artificial teeth can confidently enter the Indian market, ensuring compliance, quality, and patient safety.

For personalized assistance, contact our regulatory consulting team to start your CDSCO licensing journey today.