CDSCO License for Bite registration rim wax, plate

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

Bite registration rim wax plates are essential dental materials used to accurately register jaw relations in prosthodontics. As a prefabricated wax plate, sometimes reinforced with metal or polymer foils, these devices play a critical role in dental restorations. Given their clinical importance and patient contact, regulatory compliance in India is mandatory before marketing or manufacturing. With over 25 years of experience and having successfully assisted 500+ companies, we offer expert insights into obtaining your CDSCO license for this Class B dental device under notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022.

CDSCO Regulatory Framework for Dental Devices: Bite Registration Rim Wax

In India, medical devices including dental materials fall under the purview of the Central Drugs Standard Control Organization (CDSCO). The government regulates such materials to ensure safety, efficacy, and quality standards. The notification dated 10.10.2022 specifically classifies bite registration rim wax as a Class B device, reflecting a low to moderate risk level.

Manufacturers or importers of these devices must obtain the appropriate license before commercial distribution. Compliance with CDSCO's comprehensive regulatory framework guarantees market access and legal conformity.

Risk Classification and License Requirements for Bite Registration Rim Wax

According to CDSCO’s classification, bite registration rim wax plates are categorized as Class B devices, which means they pose a low to moderate risk to patients. This classification requires manufacturers to obtain an MD5 manufacturing license from the State Licensing Authority.

Key points for Class B devices:

• License type: MD5 (Manufacturing License)
• Authority: State Licensing Authority
• Application Form: MD3
• Process duration: Approximately 3-4 months
• Mandatory test license: MD13 (Test License) prior to manufacturing license

For importers, the relevant license is the MD15 import license, obtained from the Central Licensing Authority.

Learn more about medical device classification.

Manufacturing License Process for Bite Registration Rim Wax (MD5)

Obtaining an MD5 manufacturing license for Class B dental devices involves a multi-step process:

1. Apply for Test License (Form MD13): Before full manufacturing, a test license must be secured to conduct product testing. This stage typically takes 1.5 to 2 months.

2. Product Testing: Testing must be performed at government-approved laboratories to validate safety and performance. Refer to the list of CDSCO-approved testing laboratories.

3. Prepare Application Documents: Compile all required technical and quality documents, including Device Master File and Plant Master File.

4. Submit Manufacturing License Application (Form MD3): Apply through the CDSCO MD Online Portal with all documents.

5. Audit by Notified Body: A mandatory audit by a notified body assesses compliance with quality and regulatory requirements. Find an appropriate notified body here.

6. Respond to Queries: Address any observations or queries raised by the authority or notified body.

7. Grant of MD5 License: Upon satisfactory review and audit, the manufacturing license is granted.

Manufacturing License Documents Required for Bite Registration Rim Wax

Proper documentation is crucial for a smooth approval process. For an MD5 license for bite registration rim wax, the following documents are typically required:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety Certificate (Fire NOC)
• Pollution Control Board Clearance (Pollution NOC)
• Device Master File (DMF) detailing formulation, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (details on manufacturing facilities) (Plant Master File Guide)
• Essential Principles Checklist affirming compliance with regulatory standards
• Risk Management File demonstrating safety assessments (Risk Management Guidance)
• Test Reports from CDSCO-approved laboratories
• Labeling and Instructions for Use (IFU) samples
• Quality Management System (QMS) Documents such as ISO 13485 certification

Import License Process for Bite Registration Rim Wax (MD15)

For companies importing bite registration rim wax into India, an MD15 import license is mandatory before product release. The process is centralized and requires submission to the CDSCO Central Licensing Authority.

Steps include:

1. Document Preparation: Assemble all relevant documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and device-specific technical files.

2. Submit Application (Form MD14): Apply via the CDSCO MD Online Portal using Form MD14.

3. Resolution of Queries: Respond promptly to any clarifications requested by the licensing authority.

4. Grant of MD15 License: Upon acceptance, the import license is issued.

No test license is required for imports.

Import License Documents Required for Bite Registration Rim Wax

• Valid Manufacturing License from the country of origin
• Free Sale Certificate attesting legal marketing abroad
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (for importers/distributors)
• Company Constitution Documents

Timeline and Processing Duration

Plan your regulatory timeline accordingly to avoid market entry delays.

Government Fees and Costs

For bite registration rim wax (Class B device), the fee structure for manufacturing license (MD5) is:

• Application Fee: Rs. 5,000 per application
• Per Product Fee: Rs. 500 per product

For import license (MD15), fees depend on device class but for Class B:

• Site Fee: $2,000 per site
• Product Fee: $1,000 per product

Additional costs include testing fees at government-approved labs and audit fees charged by notified bodies.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Schedule testing early and select government-approved labs with shorter lead times. Maintain good communication to track progress.

Challenge 2: Incomplete or Poor Documentation

• Solution: Use detailed checklists and expert support to prepare Device and Plant Master Files. Ensure QMS documents are up to date.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits before notified body visits. Train technical staff on regulatory requirements.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly and thoroughly to CDSCO queries with supporting evidence to avoid back-and-forth delays.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized dental materials like bite registration rim wax. Our 25+ years of regulatory consultancy expertise have helped over 500 clients seamlessly obtain MD5 and MD15 licenses.

We provide:

• End-to-end documentation preparation
• Pre-audit readiness assessments
• Strategic guidance on testing labs and notified bodies
• Prompt query management
• Liaison with CDSCO authorities

Contact us to leverage our proven track record and accelerate your device’s market entry.

Getting Started with Your CDSCO License Application for Bite Registration Rim Wax

1. Assess your product classification to confirm your device falls under Class B dental materials.

2. Initiate a test license (MD13) application through the CDSCO MD Online Portal. Begin compiling required documents simultaneously.

3. Select a CDSCO-approved testing laboratory for product evaluation to comply with regulatory mandates.

4. Prepare your Device Master File and Plant Master File with detailed manufacturing and quality information.

5. Schedule a notified body audit early to align timelines.

6. Submit your MD5 manufacturing license application (Form MD3) once testing and documentation are complete.

7. Engage with an experienced regulatory consultant to streamline the process and troubleshoot challenges.

Taking these practical steps will ensure a smooth, timely approval for your bite registration rim wax, enabling you to confidently access the Indian dental device market.

For detailed assistance and personalized support, explore our MD5 License Guide.

By adhering to these expert recommendations, manufacturers and importers of bite registration rim wax plates can efficiently meet CDSCO requirements, reduce approval delays, and establish a strong compliance foundation for sustained market success.