CDSCO License for Dental examination kit

Comprehensive Guide to CDSCO Licensing for Dental Examination Kits (Class A)

As specialists with over 25 years of experience and having successfully assisted 500+ companies in securing CDSCO licenses, we understand the nuances of medical device regulation in India. Dental examination kits, categorized under Class A and notified under 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, require meticulous adherence to the Central Drugs Standard Control Organization (CDSCO) framework to ensure compliance and smooth market access.

Understanding the Regulatory Importance for Dental Examination Kits

Dental examination kits are vital tools used by dental professionals for diagnostic purposes. Despite their low-risk classification (Class A), these devices must comply with stringent regulatory standards to guarantee safety, efficacy, and quality. Obtaining the appropriate CDSCO license not only ensures legal marketing but builds trust with healthcare providers and end-users.

CDSCO Regulatory Framework for Dental Examination Kits

Under the Indian Medical Device Rules (MDR) 2017, dental examination kits fall under Class A, which is the lowest risk category. This classification subjects them to licensing by the State Licensing Authority through the MD5 license process. The regulatory process involves product testing, documentation, and facility audits to demonstrate compliance with the Essential Principles of safety and performance.

Risk Classification and License Requirements for Dental Examination Kits

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Regulatory Authority: State Licensing Authority
• Notification Reference: 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022

Class A devices like dental examination kits require a straightforward yet thorough process involving a test license, product testing, documentation, and audit by a notified body.

Manufacturing License Process (MD5) for Dental Examination Kits

1. Test License (Form MD13): Begin by applying for a test license, valid for 1.5 to 2 months, allowing sample testing in approved labs.
2. Product Testing: Conduct mandatory testing at one of the CDSCO approved testing laboratories. For dental kits, tests typically include biocompatibility, sterility (if applicable), and performance evaluation.
3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and QMS records.
4. Application for MD5 License (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal alongside requisite documents.
5. Audit by Notified Body: Undergo an on-site audit by a state-approved notified body. You can check the list of notified bodies here. The audit will verify compliance with Good Manufacturing Practices (GMP) and QMS.
6. Resolution of Queries: Address any observations or queries raised by the CDSCO or notified body promptly.
7. Grant of License: Upon successful completion, the MD5 license is issued, permitting manufacture and sale within India.

Manufacturing License Documents Required for Dental Examination Kits

• Company Constitution Documents (e.g., incorporation certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – detailed design and formulation of the dental kit (Device Master File Guide)
• Plant Master File (PMF) – manufacturing processes and facility details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485 certification is highly recommended)

Import License Process (MD15) for Dental Examination Kits

If you plan to import dental examination kits rather than manufacture them in India, the MD15 license is mandatory.

• Authority: Central Licensing Authority
• Process: Prepare documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and submit application using Form MD14 via the CDSCO MD Online Portal.
• Timeline: Typically 5 to 6 months
• Fees: For Class A devices, fees are $1000 per site plus$50 per product.

Import License Documents Required

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

Timeline and Processing Duration

These timelines assume prompt submission of complete documentation and timely responses to queries. Delays often occur due to incomplete paperwork or non-compliance during audits.

Government Fees and Costs

• Application Fee: Rs 5000 per application
• Product Fee: Rs 500 per product
• Additional costs may include fees for notified body audit and testing laboratory charges.

Budgeting for these expenses in advance can prevent financial surprises during the licensing process.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all required documents, especially the Device Master File and Risk Management File, are comprehensive and up-to-date.
• Delays in Testing: Coordinate with approved labs early and submit samples promptly to avoid bottlenecks.
• Audit Non-Compliance: Conduct internal audits and staff training before the notified body visit.
• Query Management: Maintain clear communication channels and respond to CDSCO queries with supporting evidence swiftly.

Expert Consultation and Support

Leveraging our extensive expertise, we provide end-to-end support—from initial classification and documentation to audit preparedness and application submission. Manufacturers and importers benefit from our practical insights, reducing approval times and enhancing compliance.

Getting Started with Your CDSCO License Application for Dental Examination Kits

1. Determine your device classification and applicable license type. For dental examination kits, this is typically the MD5 manufacturing license.
2. Prepare your documentation meticulously, referencing our Device Master File guide and Plant Master File guide.
3. Apply for the test license (Form MD13) through the CDSCO MD Online Portal.
4. Coordinate product testing with approved laboratories early.
5. Schedule and prepare for the notified body audit by selecting from the list of notified bodies.
6. Submit your manufacturing license application (Form MD3) once all prerequisites are met.

Embarking on the CDSCO licensing journey with a clear roadmap and expert guidance dramatically increases your chances of timely approval and successful market entry. Contact us to leverage our proven track record and comprehensive support tailored for dental examination kit manufacturers and importers.