CDSCO License for Bite registration rim

Comprehensive Guide to CDSCO Licensing for Bite Registration Rim (Class B Dental Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the Bite Registration Rim. As a schematic model of the dental arch used to record jaw relationships, this device falls under the Class B risk category according to the CDSCO classification. With over 25 years of expertise and having supported 500+ companies in obtaining CDSCO licenses, we provide you a detailed, practical roadmap to successfully register your Bite Registration Rim for manufacture and import in India.

Understanding the CDSCO Regulatory Framework for Bite Registration Rim

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. The Bite Registration Rim is notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, categorizing it as a Class B dental device.

Class B devices are considered low to moderate risk, requiring a manufacturing license (MD5) issued by the State Licensing Authority and an import license (MD15) granted by the Central Licensing Authority if you plan to import.

Risk Classification and License Requirements

• Device Name: Bite Registration Rim
• Risk Class: B (Low to moderate risk)
• Category: Dental
• License Type for Manufacturing: MD5 (Form MD3)
• License Type for Import: MD15 (Form MD14)

Knowing your device’s classification upfront helps streamline the regulatory process and avoid costly delays.

Manufacturing License Process (MD5 License)

For manufacturing the Bite Registration Rim in India, you need to secure an MD5 license, issued by the State Licensing Authority. Here’s a stepwise overview of the process:

1. Apply for Test License (Form MD13):
   • Duration: 1.5 to 2 months
   • Purpose: To manufacture and test the device before full license
2. Product Testing:
   • Conduct tests at CDSCO-approved laboratories. Refer to the list of testing laboratories for accredited centers.
   • Testing ensures compliance with essential principles and safety standards.
3. Document Preparation:
   • Compile all required technical and quality documents.
4. Apply for Manufacturing License (Form MD3):
   • Submit application through the CDSCO MD Online Portal.
5. Audit by Notified Body:
   • The notified body conducts a facility audit to verify compliance. Check the list of notified bodies for applicable auditors.
6. Respond to Queries:
   • Address any observations from CDSCO or the notified body promptly.
7. Grant of License (Form MD5):
   • Upon successful audit and document review, the manufacturing license is granted.

Manufacturing License Documents Required

For the Bite Registration Rim, ensure you prepare the following essential documents:

• Company Constitution (Partnership Deed, MOA, or Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF): Refer to our Device Master File guide for comprehensive insights
• Plant Master File (PMF): See our Plant Master File guide for preparation tips
• Essential Principles Checklist (Compliance with Safety and Performance Requirements)
• Risk Management File (Per ISO 14971 standards) – Learn more about Risk Management
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15 License)

If you intend to import the Bite Registration Rim, an MD15 import license from CDSCO’s Central Licensing Authority is mandatory. The process involves:

1. Document Preparation:
   • Collect all required documents listed below.
2. Application Submission:
   • Submit Form MD14 via the CDSCO MD Online Portal.
3. Queries Resolution:
   • Address any clarifications requested by CDSCO.
4. Grant of Import License (Form MD15):
   • License is issued typically within 5-6 months.

Import License Documents Required

For the Bite Registration Rim, ensure submission of:

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

Timeline and Processing Duration

Note: The test license (MD13) phase for manufacturing is critical and takes 1.5-2 months, followed by product testing and audit.

Government Fees and Costs

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete documentation or audit observations.

Solution: Prepare your Device Master File and Plant Master File meticulously. Use our Device Master File guide and Plant Master File guide to avoid common pitfalls.

Challenge: Difficulty in identifying suitable notified body for audits.

Solution: Refer to the official list of notified bodies and engage early for scheduling audits.

Challenge: Uncertainty about risk management documentation.

Solution: Implement ISO-compliant risk management systems as outlined in our Risk Management resource.

Expert Consultation and Support

With extensive experience in Indian regulatory affairs, we guide you through every step — from test license application to final audit and license grant. Our tailored approach reduces turnaround time and ensures compliance with the latest CDSCO notifications and guidelines.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm the Bite Registration Rim as Class B using the Medical Device Classification tool.
2. Prepare Documentation: Develop your Device Master File, Plant Master File, and risk management plan.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate the manufacturing license process.
4. Schedule Product Testing: Coordinate with a CDSCO-approved testing laboratory.
5. Plan for Audit: Engage a notified body early to schedule your manufacturing site audit.
6. Submit Manufacturing License Application: Apply using Form MD3 for the MD5 license or Form MD14 for import license as applicable.

Embarking on the licensing journey for your Bite Registration Rim requires strategic planning, attention to detail, and adherence to regulatory timelines. Leverage our industry expertise to navigate the process confidently and bring your dental device to the Indian market successfully.