CDSCO License for Dental suction system pump

Comprehensive Guide to CDSCO Licensing for Dental Suction System Pumps (Class B)

As specialists with over 25 years of experience and having supported 500+ companies, we understand the nuances of obtaining CDSCO licenses for medical devices like the Dental Suction System Pump. This electrically powered device, classified as Class B under the CDSCO framework, serves as the suction source in dental treatment units, making regulatory compliance essential for safe and legal market entry in India.

Understanding the Device and Its Regulatory Importance

The Dental Suction System Pump is critical for maintaining hygiene and operational efficiency in dental clinics. Being a Class B device, it carries a moderate risk level, which means regulatory oversight includes thorough testing, documentation, and state-level licensing to ensure patient safety and device reliability.

CDSCO Regulatory Framework for Dental Suction System Pump

The device falls under the dental category with notification number 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. The Central Drugs Standard Control Organization (CDSCO) governs medical device registration, manufacturing, and import licensing in India. For Class B devices, the licensing authority is the State Licensing Authority, requiring adherence to the MD5 license process.

Risk Classification and License Requirements

Class B devices like the Dental Suction System Pump require an MD5 license (Application Form MD3) granted by the State Licensing Authority. This classification demands a comprehensive approach involving product testing, quality management systems, and compliance with Essential Principles.

Step-by-Step Manufacturing License Process (MD5 License)

1. Apply for Test License (Form MD13): Before manufacturing, obtain a test license which typically takes 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved government laboratories to validate safety and performance. Refer to the list of testing laboratories for authorized centers.
3. Document Preparation: Assemble required documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Submit Application (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
5. Notified Body Audit: Engage a notified body for facility audit as part of compliance verification. Check the list of notified bodies to select an approved auditor.
6. Respond to Queries: Address any observations from the department or notified body promptly.
7. License Grant (Form MD5): Upon satisfactory compliance, CDSCO issues the manufacturing license.

Manufacturing License Documents Required

• Company Constitution Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control NOC
• Device Master File (detailed device specifications, design, manufacturing process) – see our comprehensive Device Master File guide
• Plant Master File (manufacturing facility details) – refer to our Plant Master File guide
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation – learn more about Risk Management
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, typically ISO 13485:2016 certification

Import License Process (MD15 License) for Dental Suction System Pump

If you are an importer, you will need to obtain an MD15 import license from the Central Licensing Authority. The process includes:

• Comprehensive document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Application submission via the CDSCO MD Online Portal.
• Query resolution phase.
• License grant typically takes 5 to 6 months.

Refer to our detailed Import License guide for practical insights.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab availability
• Document Preparation: 2 to 3 weeks
• Manufacturing License Application (MD5): 1.5 to 2 months including audit and query resolution

Total time for MD5 license: Approximately 3 to 4 months

Government Fees and Costs

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

Additional costs include laboratory testing fees and notified body audit charges, which vary based on the scope and location.

Common Challenges and Solutions

• Delays in Document Preparation: Ensure thorough pre-audit documentation and use checklists to avoid rework.
• Testing Laboratory Backlogs: Book testing slots early and consider multiple CDSCO-approved labs.
• Audit Non-Conformities: Engage experienced notified bodies and prepare your QMS and plant for the audit thoroughly.
• Query Resolution Delays: Respond promptly with detailed evidence and updated documents.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for Class B devices like dental suction pumps. Our extensive experience enables us to guide manufacturers and importers through every step—from documentation to audit preparation—ensuring compliance and timely approvals.

Getting Started with Your CDSCO License Application

1. Assess Your Device Class: Confirm your device’s classification (Class B) and regulatory pathway.
2. Prepare Initial Documentation: Begin assembling your Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid delays.
5. Engage a Notified Body: Select an auditor from the official list of notified bodies and prepare for your plant audit.
6. Submit Manufacturing License Application (MD5): Utilize the portal for timely submission and track application status.
7. Prepare for Audit and Queries: Ensure your team is ready to address any compliance questions promptly.

Taking these actionable steps will streamline your licensing journey and help you bring your Dental Suction System Pump to the Indian market efficiently and compliantly. For tailored assistance, reach out to our regulatory experts who have successfully guided over 500 companies through the CDSCO licensing process.