CDSCO License for Orthodontic Tube

Comprehensive Guide to CDSCO Licensing for Orthodontic Tubes (Class B Medical Device)

Orthodontic Tubes are essential small metal components welded onto molar bands, designed to securely hold archwires, lip bumpers, facebows, and other orthodontic accessories. Classified under risk Class B medical devices in India, these devices fall within the catheter category and require compliance with the Central Drugs Standard Control Organization (CDSCO) regulations for manufacturing and import. With our 25+ years of regulatory expertise and successful support to over 500 companies, we provide you with a detailed, step-by-step roadmap to obtain your CDSCO license efficiently.

Understanding the CDSCO Regulatory Framework for Orthodontic Tubes

Orthodontic Tubes are notified under the CDSCO notification number 29/Misc/3/2017-DC (292) dated 06.06.2018. As a Class B medical device, they are considered low to moderate risk, mandating compliance via the State Licensing Authority through an MD5 manufacturing license for domestic manufacturers or an MD15 import license for importers.

This regulatory framework ensures the safety, efficacy, and quality of orthodontic devices entering the Indian market, aligning with the Medical Device Rules, 2017.

Risk Classification and License Requirements for Orthodontic Tubes

• Risk Class: B (Low to moderate risk)
• Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import
• License Type: MD5 Manufacturing License (Form MD3) for manufacturers; MD15 Import License (Form MD14) for importers

Manufacturers of orthodontic tubes must first secure a Test License (Form MD13) before applying for the MD5 license. Importers must directly apply for the import license (MD15) without the test license requirement.

Manufacturing License Process for Orthodontic Tubes (MD5 License)

The MD5 license application process, governed by the State Licensing Authority, typically spans 3 to 4 months and involves the following steps:

1. Obtain Test License (Form MD13): Required before manufacturing and testing, taking approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance. Refer to the Testing Laboratories List for authorized facilities.
3. Document Preparation: Compile technical documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, test reports, labels, instructions for use (IFU), and quality management system (QMS) documents.
4. License Application Submission (Form MD3): File your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit conducted by a CDSCO-approved notified body from the Notified Bodies List verifies compliance.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon successful audit and document verification, the manufacturing license is granted.

Manufacturing License Documents Required for Orthodontic Tubes

• Company constitution documents (incorporation certificate, partnership deed)
• Proof of ownership or lease agreement for manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution NOCs
• Device Master File (technical specifications, design, and manufacturing processes) – see our Device Master File Guide
• Plant Master File – outlining manufacturing site details and quality systems (Plant Master File Guide)
• Essential Principles Checklist to demonstrate compliance with safety standards
• Risk Management File documenting risk assessments and mitigation strategies (Risk Management Tips)
• Product test reports from CDSCO-approved laboratories
• Labeling and Instructions for Use (IFU) documents
• Quality Management System documents, typically ISO 13485:2016 certification

Import License Process for Orthodontic Tubes (MD15 License)

Importers seeking to bring orthodontic tubes into India must apply for an MD15 import license through the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

1. Document Preparation: Compile required documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. License Application Submission: Submit the application using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond to any departmental queries promptly.
4. Grant of License: Upon satisfactory review, the MD15 import license is granted.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 certification
• CE Certificate or other relevant international certifications
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company constitution and registration documents

Timeline and Processing Duration

Delays often occur due to incomplete documentation or delayed responses to queries. Early preparation and expert guidance can significantly reduce processing times.

Government Fees and Costs

For Orthodontic Tubes (Class B), the fee structure is as follows:

• MD5 Manufacturing License:

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• MD15 Import License:

  • Site fee: $2,000 per site
  • Per product fee: $1,000

Additional costs include testing fees charged by approved laboratories and audit fees by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Avoid delays by meticulously preparing all documents, referencing our Device Master File Guide and Plant Master File Guide.
• Testing Delays: Schedule early with CDSCO-approved labs and confirm testing protocols to prevent retesting.
• Audit Non-Compliance: Engage notified bodies listed on the Notified Bodies List experienced in orthodontic device audits.
• Slow Query Resolution: Maintain clear communication channels and assign dedicated personnel to handle CDSCO queries promptly.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO licensing projects, our expert consultants provide end-to-end support—from classification advice, documentation preparation, test license acquisition, audit facilitation, to final license grant. We ensure your Orthodontic Tube complies fully with the latest regulatory standards, minimizing risk and accelerating market access.

Getting Started with Your CDSCO License Application for Orthodontic Tubes

1. Identify Your Regulatory Pathway: Confirm if you are manufacturing domestically (MD5) or importing (MD15).
2. Create an Account on CDSCO MD Online Portal: Register and familiarize yourself with the platform at the CDSCO MD Online Portal.
3. Gather Required Documents: Refer to the comprehensive lists provided and begin compiling your Device Master File, Plant Master File, and testing arrangements.
4. Apply for Test License (If Manufacturing): Submit Form MD13 early to commence product testing.
5. Engage a Notified Body: Schedule your audit with a notified body experienced in Class B devices.
6. Prepare for Audit and Queries: Ensure your quality system and documentation are audit-ready; respond swiftly to any queries.

By following these practical steps and leveraging our expertise, you can confidently navigate the CDSCO licensing landscape and bring your Orthodontic Tubes to the Indian market efficiently and compliantly.