CDSCO License for Dental impression tray, single-use

Comprehensive Guide to CDSCO Licensing for Single-Use Dental Impression Trays (Class A)

Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to introduce dental products like single-use dental impression trays. As a trusted regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we provide you with a detailed, actionable roadmap tailored for this device type.

Understanding the Device: Single-Use Dental Impression Tray (Class A)

A dental impression tray is a critical tool used primarily to create molds for custom dental prostheses such as dentures. Being a single-use device, it eliminates cross-contamination risks and aligns with modern infection control protocols. Classified as Class A under CDSCO regulations, it is considered a low-risk device but still requires compliance with regulatory standards.

Category: Dental Risk Class: A (Low Risk) Notification: 29/Misc./03/2020-DC (140) Part-5 Notification Date: 10.10.2022

CDSCO Regulatory Framework for Dental Impression Trays

India's Central Drugs Standard Control Organization (CDSCO) governs the registration, licensing, and regulation of medical devices. The regulatory framework mandates that Class A devices like single-use dental impression trays obtain an MD5 Manufacturing License, issued by the State Licensing Authority.

This license ensures the device meets safety, quality, and efficacy criteria, safeguarding patient health and building market trust.

Risk Classification and License Requirements

According to CDSCO's medical device classification, dental impression trays fall under Class A, which entails:

License Type: MD5 Manufacturing License
Issuing Authority: State Licensing Authority
Application Form: MD3 (for manufacturing license)
Test License Required: Yes, Form MD13

For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license is a multi-step process:

Test License Application (Form MD13): Initiate with a test license for 1.5-2 months to allow product testing.
Product Testing: Conduct testing at CDSCO-approved government laboratories to verify compliance.
Document Preparation: Compile essential documents including Device Master File and Plant Master File.
Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit conducted by a notified body listed here to verify manufacturing compliance.
Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review and audit, receive the manufacturing license.

Manufacturing License Documents Required

For a smooth application, prepare the following documentation:

Company Constitution: Proof of legal entity and ownership.
Proof of Ownership or Lease of Manufacturing Premises: Ensures facility legitimacy.
Technical Staff Details: Qualifications and experience of key personnel.
Fire NOC & Pollution Control NOC: Environmental and safety compliance certificates.
Device Master File (DMF): Detailed device specifications, manufacturing processes, and quality control measures. Our Device Master File guide offers comprehensive insights.
Plant Master File (PMF): Description of manufacturing site, equipment, and quality systems. Learn how to create a robust PMF here.
Essential Principles Checklist: Demonstrates conformity to regulatory standards.
Risk Management File: Risk assessment and mitigation strategies tailored to the device. Visit our Risk Management resource for best practices.
Test Reports: Product testing results from CDSCO-approved labs listed here.
Labels and Instructions for Use (IFU): Device labeling complying with CDSCO guidelines.
Quality Management System (QMS) Documents: Evidence of implemented quality systems such as ISO 13485.

Import License Process (MD15) for Dental Impression Trays

If you plan to import these trays into India, you must obtain an MD15 Import License issued by the Central Licensing Authority.

The process includes:

Preparation of documents including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and other compliance files.
Application submission via the CDSCO MD Online Portal.
Addressing departmental queries.
License grant typically within 5-6 months.

For detailed guidance, see our Import License guide.

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 - 2 months
Product Testing	3 - 4 weeks
Document Preparation	2 - 3 weeks
Application Processing (MD5)	1 - 1.5 months
Audit and Query Resolution	3 - 4 weeks
Total Estimated Time	Approximately 3-4 months

Government Fees and Costs

Test License Fee (MD13): Included in overall process, no separate fee.
MD5 Manufacturing License Fee: Rs. 5,000 per application plus Rs. 500 per product.
Testing Charges: Variable depending on the number of tests; budget approximately Rs. 50,000 - Rs. 1,00,000.
Notified Body Audit Fee: Separate contract with the notified body; typically Rs. 50,000 - Rs. 1,50,000.

Common Challenges and Solutions

Incomplete Documentation: Missing or incorrect documents delay approvals. Solution: Use our detailed document checklist and templates.
Delayed Testing: Testing labs often have backlogs. Solution: Schedule testing early and choose labs with shorter lead times.
Audit Non-Compliance: Audit failures can occur due to inadequate QMS. Solution: Implement a robust ISO 13485 system and conduct internal audits.
Query Resolution Delays: Slow responses extend timelines. Solution: Assign dedicated team members for prompt communication.

Expert Consultation and Support

With over 25 years of regulatory consulting, we bring unparalleled expertise to your CDSCO license journey. Our services include:

Regulatory strategy tailored to your device and business model.
End-to-end application preparation and submission.
Assistance with QMS implementation and internal audits.
Liaison with CDSCO and notified bodies to expedite processing.
Post-license compliance and vigilance support.

Getting Started with Your CDSCO License Application

Assess your Device Classification: Confirm your device’s Class A status.
Prepare Documentation Early: Begin compiling your Device Master File, Plant Master File, and quality system documents.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
Schedule Product Testing: Coordinate with CDSCO-approved labs promptly.
Engage a Notified Body: Identify and contract with a notified body from the official list for the audit phase.
Submit Manufacturing License Application: Once testing and documentation are ready, file Form MD3 through the CDSCO portal.
Prepare for Audit: Conduct internal audits and ensure compliance to pass the notified body's inspection.
Respond to Queries: Allocate resources to address any CDSCO or notified body queries quickly.

Embarking on this regulatory pathway with expert guidance ensures a smooth, timely approval process for your single-use dental impression trays, enabling you to confidently enter and compete in the Indian dental device market.

For personalized consultation or to initiate your application process, feel free to contact us and leverage our proven track record in CDSCO licensing.

Note: All timelines and fees mentioned are indicative and subject to change based on CDSCO updates or specific case circumstances.

CDSCO License for Dental impression tray, single-use

Medical Device Information

Important Notice for Class A Devices

Intended Use