CDSCO License for Intubation teeth protector

Introduction to Intubation Teeth Protector and Regulatory Importance

An Intubation Teeth Protector is a specialized medical device designed to safeguard patients' upper and lower teeth during endotracheal (ET) intubation procedures. Given its critical role in pain management and patient safety during airway management, regulatory compliance in India is mandatory before manufacturing or importing this device. The Central Drugs Standard Control Organization (CDSCO) governs the regulatory framework, ensuring that devices like the Intubation Teeth Protector meet quality, safety, and performance standards.

We bring over 25 years of experience assisting more than 500 medical device companies navigate CDSCO licensing processes successfully. This guide focuses on the specific regulatory pathway for the Intubation Teeth Protector, classified as a Class A medical device, under the CDSCO notification File No. 29/Misc./03/2020-DC (178), dated 13.9.2021.

CDSCO Regulatory Framework for Intubation Teeth Protector

Under CDSCO regulations, medical devices are categorized into Classes A, B, C, and D based on risk. The Intubation Teeth Protector falls under Class A — the lowest risk category — which simplifies the licensing process slightly but still requires strict adherence to compliance standards.

Manufacturers or importers must obtain a manufacturing license (MD5) or import license (MD15) accordingly. Compliance ensures the device conforms to the Essential Principles of safety and performance, and is manufactured under a robust Quality Management System (QMS).

Risk Classification and License Requirements for Class A Devices

The Intubation Teeth Protector is a Class A device, which means it has minimal risk associated with its use. CDSCO mandates that Class A devices require an MD5 manufacturing license granted by the State Licensing Authority.

For importers, an MD15 license from the Central Licensing Authority is needed. Since this device is Class A, the MD5 license is typically the focus for manufacturers in India.

Manufacturing License Process (MD5) for Intubation Teeth Protector

The MD5 license process is comprehensive yet streamlined for Class A devices:

1. Test License (Form MD13): Initiate with a test license application, which takes approximately 1.5 to 2 months. This allows testing of the Intubation Teeth Protector samples at CDSCO-approved laboratories.

2. Product Testing: Conduct tests in government-approved labs to verify compliance with applicable standards. Refer to the list of testing laboratories for authorized centers.

3. Document Preparation: Prepare essential documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, and risk management files.

4. Application Submission (Form MD3): Apply for the MD5 manufacturing license via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body to assess compliance. Check the list of notified bodies to select an authorized agency.

6. Queries Resolution: Address any queries raised by the department or notified body promptly.

7. License Grant (Form MD5): Upon successful compliance and audit, the MD5 license is granted, enabling legal manufacturing.

Manufacturing License Documents Required for Class A Devices

For the Intubation Teeth Protector MD5 license, ensure the following documents are meticulously compiled:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details and Qualifications
• Fire NOC (No Objection Certificate)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File guide)
• Plant Master File (PMF) describing manufacturing site and processes (Plant Master File guide)
• Essential Principles Checklist confirming compliance with CDSCO requirements
• Risk Management File reflecting hazard analysis and mitigation strategies (Risk Management)
• Test Reports from accredited laboratories
• Labels and Instructions for Use (IFU) compliant with labeling requirements
• Quality Management System (QMS) documentation (ISO 13485:2016 preferred)

Import License Process (MD15) for Intubation Teeth Protector

For companies importing the Intubation Teeth Protector into India, an MD15 license is necessary. This process is handled by the Central Licensing Authority and typically takes 5 to 6 months.

Steps include:

1. Document Compilation: Collect documents such as the foreign manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, and wholesale license.

2. Application Submission (Form MD14): Submit the application through the CDSCO MD Online Portal.

3. Review and Queries: Address any queries raised by the CDSCO.

4. Grant of MD15 License: Upon satisfactory review, the import license is granted.

Note: No test license is required for importers.

Import License Documents Required

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

Timeline and Processing Duration

For the Intubation Teeth Protector (Class A device), expect the following approximate timelines:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (depending on lab availability)
• MD5 License Processing: 1.5 to 2 months

Total Duration: Approximately 3 to 4 months from test license initiation to final license grant.

For imports (MD15), expect 5 to 6 months.

Government Fees and Costs

The fee structure for Class A devices under the MD5 license includes:

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

Additional costs to budget for:

• Laboratory testing fees (varies by testing lab)
• Notified Body audit charges
• Consultancy fees (if engaging external consultants)

For import licenses (MD15), fees are site and product-dependent, typically starting at $1,000 per site plus$50 per product for Class A devices.

Common Challenges and Solutions

Challenge: Delays in test report acquisition due to lab backlogs.

Solution: Plan testing early and select labs based on capacity and proximity. Refer to the CDSCO list of testing laboratories to identify less congested centers.

Challenge: Incomplete or inconsistent documentation.

Solution: Use detailed checklists and templates for DMFs, PMFs, and risk files. Our Device Master File guide and Plant Master File guide are invaluable resources.

Challenge: Addressing audit findings or queries.

Solution: Maintain open communication with notified bodies and CDSCO officers. Respond promptly with clarifications supported by evidence.

Expert Consultation and Support

Navigating CDSCO regulatory pathways can be complex and time-consuming. With over 25 years of experience, we have successfully guided 500+ companies through licensing for Class A devices like the Intubation Teeth Protector.

Our services include:

• Comprehensive gap assessments and regulatory strategy
• Documentation preparation and review
• Coordination with testing labs and notified bodies
• Application submission and follow-up
• Training on post-license regulatory compliance

Contact us early in your product development cycle to minimize delays and ensure smooth approval.

Getting Started with Your CDSCO License Application for Intubation Teeth Protector

1. Assess your product classification: Confirm the Intubation Teeth Protector is Class A under CDSCO guidelines (Medical Device Classification).

2. Prepare initial documentation: Begin drafting your Device Master File, Plant Master File, and Risk Management Files.

3. Apply for the Test License (Form MD13): Submit via the CDSCO MD Online Portal.

4. Coordinate product testing: Schedule tests at an approved laboratory.

5. Compile final application: Gather all required documents for the MD5 license submission.

6. Select and schedule notified body audit: Engage an approved body early to avoid scheduling delays.

7. Submit MD5 application (Form MD3): Through the online portal and track progress.

By following these actionable steps and leveraging our expertise, you can confidently navigate the regulatory landscape and bring your Intubation Teeth Protector device to the Indian market efficiently and compliantly.