CDSCO License for Dental impression material mixer

Introduction to Dental Impression Material Mixer and Regulatory Importance

Dental impression material mixers are essential electric devices designed to homogenize dental impression materials chairside, ensuring precise dental impressions for patient care. Classified as Class A medical devices under CDSCO’s risk framework, these mixers are considered low-risk but still require stringent regulatory compliance to ensure safety and quality in the Indian market. Compliance with CDSCO licensing is mandatory for manufacturers and importers to lawfully market these devices, protecting end-users and building trust.

CDSCO Regulatory Framework for Dental Impression Material Mixer

Under the Medical Device Rules, 2017, dental impression material mixers fall under Class A devices as per the latest notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Being a Class A device, the regulatory authority responsible is the State Licensing Authority, which grants the MD5 manufacturing license. This framework ensures that devices with the lowest risk undergo appropriate scrutiny, balancing safety and ease of market entry.

Risk Classification and License Requirements

Dental impression material mixers are categorized as Class A devices due to their limited risk profile. The key license required for manufacturing these devices is the MD5 license (Form MD3 application), issued by the State Licensing Authority. Importers of such devices would require an MD15 import license from the Central Licensing Authority.

License Types Summary:

• Manufacturing: MD5 License (Form MD3)
• Import: MD15 License (Form MD14)

Manufacturing License Process (MD5)

The MD5 license process for Dental Impression Material Mixers involves several critical steps:

1. Test License Application (Form MD13): This preliminary permit allows you to manufacture sample devices for testing purposes. It typically takes 1.5 to 2 months for approval.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with applicable standards. Access the list of testing laboratories.
3. Documentation Preparation: Assemble all required documents, including your Device Master File and Plant Master File.
4. MD5 License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts site audits to verify compliance. Refer to the notified bodies list.
6. Resolution of Queries: Address any queries raised by the department or the notified body promptly.
7. Grant of License: Upon successful review, the MD5 license is granted in Form MD5.

Total timeline: Approximately 3 to 4 months from test license to final MD5 license issuance.

Manufacturing License Documents Required for MD5

For dental impression material mixers, you must prepare the following documents:

• Company Constitution (e.g., partnership deed, MOA/ AOA)
• Proof of ownership or rental agreement of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire NOC and Pollution Control Board clearance
• Device Master File detailing device specifications and manufacturing process (See our Device Master File guide)
• Plant Master File describing the manufacturing facility (More info at our Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation per risk management best practices
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 compliant

Practical Tip: Early engagement with notified bodies and testing labs helps identify gaps in documentation and reduces approval delays.

Import License Process (MD15)

If you are importing dental impression material mixers into India, you will need the MD15 import license issued by the Central Licensing Authority. The process entails:

1. Document Preparation: Collate documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond timely to any queries raised by CDSCO.
4. License Grant: Upon satisfactory review, MD15 license will be issued.

Typical timeline: 5 to 6 months.

Import License Documents Required for MD15

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution and address proof

Timeline and Processing Duration

Being proactive in document preparation and prompt in addressing queries can help keep your application on track within these timelines.

Government Fees and Costs

For the Dental Impression Material Mixer (Class A device), the cost structure is as follows:

• MD5 License:

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

• MD15 Import License:

  • Site fee: $1,000
  • Per product fee: $50

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

Common Challenges and Solutions

• Delayed Testing Reports: Engage early with CDSCO-approved labs and submit samples promptly.
• Incomplete Documentation: Use checklists aligned with CDSCO requirements to ensure all files are complete.
• Audit Non-compliance: Conduct internal mock audits and maintain robust QMS systems.
• Query Response Delays: Assign dedicated regulatory personnel to monitor and respond swiftly.

Expert Consultation and Support

Having supported over 500 companies in obtaining CDSCO licenses, we understand the nuances of the regulatory landscape. From Device Master Files to audit preparation, our expert team can guide you to avoid common pitfalls and accelerate approvals. We emphasize hands-on support tailored specifically for Class A dental devices like impression mixers.

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm Class A status using resources such as the Medical Device Classification guide.
2. Prepare your Device and Plant Master Files meticulously.
3. Engage a CDSCO notified body early to understand audit expectations.
4. Apply for the Test License (Form MD13) to begin manufacturing samples for testing.
5. Submit samples to CDSCO-approved labs without delay.
6. Compile and submit your MD5 license application (Form MD3) via the CDSCO MD Online Portal.
7. Maintain open communication with CDSCO and the notified body to resolve queries efficiently.

By following these steps with expert guidance, manufacturers can confidently navigate the regulatory pathway and successfully launch dental impression material mixers in India’s growing medical device market.