CDSCO License for Orthodontic Software

Comprehensive Guide to CDSCO Licensing for Orthodontic Software (Class C)

Orthodontic software has become indispensable in modern dental care, enabling precise diagnosis and personalized treatment planning for orthodontic patients. As a software device classified as Class C under the CDSCO framework, it carries a moderate to high risk, necessitating stringent regulatory compliance before entering the Indian market. With over 25 years of experience assisting 500+ companies, we offer detailed insights into navigating the CDSCO licensing process for this innovative device category.

CDSCO Regulatory Framework for Orthodontic Software

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, amended periodically. Orthodontic software falls under the software category defined as a medical device intended for diagnostic or therapeutic purposes. Following Notification 29/Misc./03/2020-DC (198) dated 13.9.2021, this device is specifically recognized under the regulatory purview.

Given its diagnostic use, orthodontic software is classified as a Class C device, indicating moderate to high risk. This classification triggers compliance requirements with the central licensing authority, making the approval process more rigorous compared to lower-risk devices.

Risk Classification and License Requirements for Orthodontic Software

• Risk Class: Class C
• Regulatory Pathway: Manufacturing license under MD9 (Form MD7)
• Import License: MD15 (Form MD14)
• Authority: Central Licensing Authority (CDSCO HQ)

Class C devices require centralized approval involving product testing, document audits, and factory inspections to ensure safety and efficacy.

Manufacturing License Process for Orthodontic Software (MD9 License)

The MD9 license process for Class C devices like orthodontic software typically takes 4-5 months end-to-end. Here’s the stepwise overview:

1. Test License (Form MD13): Obtain a test license to manufacture the device prototype for evaluation. This stage takes approximately 1.5-2 months.
2. Product Testing: Conduct product testing at CDSCO-approved notified laboratories to verify compliance with essential principles and performance standards.
3. Document Preparation: Compile a comprehensive dossier including technical, quality, and safety documents.
4. Application Submission (Form MD7): File your manufacturing license application on the CDSCO MD Online Portal with complete documentation.
5. Audit and Inspection: CDSCO inspectors perform a detailed audit of manufacturing facilities, quality management systems, and technical documentation.
6. Query Resolution: Respond promptly to any queries raised during the inspection or document review.
7. Grant of License (Form MD9): Upon successful review, the manufacturing license is issued.

Manufacturing License Documents Required for Orthodontic Software

Manufacturers must prepare and submit the following key documents:

• Company Constitution: Incorporation certificates, partnership deeds, or LLP agreements
• Proof of Premises Ownership/Lease: Valid property documents
• Technical Staff Details: Qualifications and experience certificates of responsible personnel
• Fire and Pollution NOCs: Local authority clearances
• Device Master File (DMF): Detailed design, development, and validation data — see our Device Master File guide
• Plant Master File (PMF): Overview of manufacturing premises and processes — learn more from our Plant Master File guide
• Essential Principles Checklist: Compliance with CDSCO’s essential principles for medical devices
• Risk Management File: Hazard analysis and risk control measures aligned with ISO 14971; explore Risk Management best practices
• Test Reports: Certified lab test results
• Labels and Instructions for Use (IFU): User manuals and labeling compliant with CDSCO guidelines
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs

Import License Process for Orthodontic Software (MD15 License)

Importers of orthodontic software classified as Class C must secure an MD15 import license. The process includes:

1. Document Preparation: Assemble required certificates and licenses.
2. Application Submission (Form MD14): Submit the application via the CDSCO MD Online Portal.
3. Review and Query Resolution: Address any department queries.
4. License Grant: Receive the import license.

Notably, unlike manufacturing licenses, no test license is needed for imports.

Import License Documents Required

• Valid Manufacturing License: From the country of origin
• Free Sale Certificate: Issued by the competent authority of the exporting country
• ISO 13485:2016 Certificate: Demonstrating compliance with quality standards
• CE Certificate: If applicable, for devices marketed in the European Union
• Device Master File & Plant Master File
• Wholesale License: For distribution within India
• Company Constitution and Address Proof

Timeline and Processing Duration

The MD9 manufacturing license timeline includes test license issuance, product testing, documentation, and onsite audit.

Government Fees and Costs

• MD9 Manufacturing License:
  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000
• MD15 Import License (Class C):
  • Site Fee: $3,000 (~₹2,50,000)
  • Per Product Fee: $1,500 (~₹1,25,000)

Fees are to be paid online during application submission via the CDSCO portal.

Common Challenges and Solutions

• Delayed Product Testing: CDSCO notified labs may have backlogs. Plan testing early and consider multiple labs from the Testing Laboratories list.
• Incomplete Documentation: Ensure all files like DMF and PMF are thoroughly prepared. Refer to our detailed guides for accuracy.
• Audit Non-Compliance: Pre-audit your QMS and facilities to avoid common deficiencies.
• Technical Staff Qualification: Employ or contract experienced regulatory personnel familiar with software device requirements.

Expert Consultation and Support

Navigating CDSCO’s regulatory maze for Class C devices like orthodontic software demands expertise. Our team has successfully facilitated over 500 CDSCO licenses, offering:

• Tailored document preparation and review
• Regulatory strategy aligned with your product lifecycle
• Support through audit readiness and query resolution
• Liaison with CDSCO and notified bodies

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your software is Class C as per CDSCO rules; verify on Medical Device Classification.
2. Prepare Test License Application (MD13): Begin with obtaining the test license for manufacturing.
3. Identify Testing Lab: Select an approved CDSCO lab from the notified list to conduct product tests.
4. Compile Comprehensive Documentation: Use our Device Master File and Plant Master File guides.
5. Register on CDSCO MD Online Portal: Submit all your applications and fees through the official portal.
6. Schedule Facility Audit: Coordinate with CDSCO inspectors and prepare for compliance verification.
7. Respond Promptly to Queries: Efficient communication can accelerate license grant.

Embarking on the regulatory journey for your orthodontic software is complex but manageable with the right expertise and planning. Connect with us to leverage our 25+ years of regulatory experience and ensure a smooth, timely CDSCO approval.

For detailed personalized assistance, contact our regulatory experts today and take the first step towards your successful market entry in India.