CDSCO License for Orthodontic Adhesive

Comprehensive Guide to CDSCO Licensing for Orthodontic Adhesive (Class B Dental Device)

Orthodontic adhesives play a pivotal role in modern dental care, particularly in orthodontic treatments where they serve as combined etchants and primers. Specifically, the Orthodontic Adhesive used with or without light curing direct bonding is classified as a Class B medical device under CDSCO notifications, making regulatory compliance essential before entering the Indian market.

With over 25 years of expertise and having supported 500+ companies in obtaining CDSCO licenses, we provide you with a practical, step-by-step guide to secure your manufacturing or import license for this dental device.

CDSCO Regulatory Framework for Orthodontic Adhesive

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Orthodontic Adhesive, categorized under dental devices and notified via 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, falls under Class B risk classification. This classification mandates compliance with specific quality and safety standards before manufacture or import.

Understanding this framework is crucial as it determines the type of license, documentation, and approval timelines.

Risk Classification and License Requirements for Orthodontic Adhesive

Orthodontic Adhesive is classified as a Class B medical device, which denotes low to moderate risk. According to CDSCO, Class B devices require an MD5 manufacturing license if produced locally and an MD15 import license if imported.

• MD5 Manufacturing License: Granted by the State Licensing Authority
• MD15 Import License: Granted by the Central Licensing Authority

This classification impacts the application process, fees, and documentation.

Manufacturing License Process (MD5) for Orthodontic Adhesive

The MD5 license application process for Class B devices is rigorous but streamlined:

1. Test License (Form MD13): Initially, apply for a test license to manufacture the device for testing. This phase takes approximately 1.5 to 2 months.

2. Testing: Get the orthodontic adhesive tested at one of the government-approved laboratories. Testing ensures conformity with safety and performance standards.

3. Document Preparation: Compile all required documents, including your Device Master File and Plant Master File.

4. Application Submission (Form MD3): Submit your MD5 license application through the CDSCO MD Online Portal.

5. Notified Body Audit: Undergo an audit by a notified body to verify compliance. Refer to the list of notified bodies for selection.

6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.

7. License Grant (Form MD5): Upon satisfying all requirements, the license is granted.

Manufacturing License Documents Required

For your Orthodontic Adhesive manufacturing license, ensure the following documents are prepared meticulously:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire Department No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications, manufacturing process, and controls (Device Master File guide)
• Plant Master File (PMF) outlining facility layout, equipment, and quality systems (Plant Master File guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from Government Approved Labs (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485 certification

Import License Process (MD15) for Orthodontic Adhesive

If you intend to import Orthodontic Adhesive, apply for the MD15 license granted by CDSCO's Central Licensing Authority:

1. Document Preparation: Compile all mandatory documents similar to manufacturing but also include your manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, and CE Certificate.

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

3. Query Resolution: Respond to any queries raised by CDSCO.

4. License Grant (Form MD15): License is granted after thorough review.

Note that for imports, no test license is required, but timelines are longer (5-6 months).

Import License Documents Required

• Valid 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 (if applicable)
• Company Constitution

Timeline and Processing Duration

Timely submission of complete documentation and prompt query resolution can help avoid delays.

Government Fees and Costs

For MD5 License (Class B device):

• Application Fee: Rs 5,000
• Per Product Fee: Rs 500

For MD15 Import License:

• Class B Device Fee: $2,000 per site +$1,000 per product

Additional costs include testing fees at government-approved labs, audit fees charged by notified bodies, and consultancy fees if you engage expert support.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all forms and files like DMF and PMF are detailed and compliant. Use expert templates to avoid rejections.
• Delayed Testing: Plan testing schedules with approved labs well in advance.
• Notified Body Audit Non-compliance: Conduct internal pre-audits to address potential findings.
• Query Delays: Respond to CDSCO queries promptly with complete information.

We have seen manufacturers reduce license processing time by up to 20% by applying these best practices.

Expert Consultation and Support

Navigating CDSCO licensing is complex, especially for Class B dental devices like Orthodontic Adhesive. With our 25+ years of experience and over 500 successful client engagements, we offer:

• End-to-end license application management
• Document preparation and review
• Liaison with notified bodies and CDSCO officials
• Pre-audit readiness assessments

Our tailored approach ensures you meet all regulatory requirements efficiently.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your product as Class B under CDSCO notifications.
2. Prepare Documentation: Develop your Device Master File and Plant Master File using our comprehensive guides.
3. Obtain Test License: Apply for the test license (Form MD13) via the CDSCO MD Online Portal.
4. Schedule Testing: Coordinate with government-approved labs early.
5. Engage Notified Body: Select from the list of notified bodies for audit.
6. Submit MD5 Application: File your license application on the portal.
7. Manage Queries: Stay proactive in addressing CDSCO and notified body questions.

By following these actionable steps and leveraging expert support, you can successfully launch your Orthodontic Adhesive in India with full regulatory compliance.

For personalized assistance and detailed project planning, contact our regulatory consultants today to ensure a smooth and timely CDSCO license acquisition.