CDSCO License for Dental Prosthesis Priming Agent

Comprehensive Guide to CDSCO Licensing for Dental Prosthesis Priming Agent (Class B)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like the Dental Prosthesis Priming Agent. As a material intended to enhance bonding during dental restorative procedures, this device falls under the Class B risk category according to CDSCO guidelines. With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we provide a detailed, step-by-step guide tailored specifically for your device’s successful entry into the Indian market.

Understanding the Device and Its Regulatory Significance

The Dental Prosthesis Priming Agent is designed to be applied immediately before prosthesis insertion to promote effective bonding. Given its direct interaction with dental tissues and prosthetic components, the device is classified as Class B under the Indian Medical Device Rules (MDR), reflecting a moderate risk profile. Compliance with the CDSCO regulatory framework ensures safety, efficacy, and quality, instilling confidence among healthcare professionals and patients alike.

CDSCO Regulatory Framework for Dental Prosthesis Priming Agent

The Central Drugs Standard Control Organization (CDSCO) governs the approval, manufacturing, and import of medical devices in India. For Class B devices like the Dental Prosthesis Priming Agent, the manufacturing license is granted by the State Licensing Authority via the MD5 license process. This involves adherence to stringent documentation, product testing, and facility audits to confirm compliance with Indian MDR requirements.

Risk Classification and License Requirements

Device Name: Dental Prosthesis Priming Agent
Risk Class: Class B (Moderate Risk)
License Type: MD5 Manufacturing License (Application Form MD3)
Licensing Authority: State Licensing Authority

Class B devices require a combination of product testing, documentation, and audits by notified bodies to ensure compliance. The detailed classification criteria can be reviewed in our Medical Device Classification guide.

Manufacturing License Process (MD5)

The MD5 licensing path involves multiple sequential steps:

Test License Application (Form MD13): Initiate the process by applying for a test license, which typically takes 1.5 to 2 months for approval.
Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to validate device safety and performance. Refer to the list of testing laboratories for authorized facilities.
Documentation Preparation: Compile all required technical and quality documents, including Device Master File and Plant Master File.
MD5 License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: Undergo a thorough audit by a CDSCO-recognized notified body. You can check the notified bodies list to select an auditor.
Resolution of Queries: Address any observations or queries raised during audit and application review.
Grant of MD5 License: Upon satisfactory compliance, the license is issued on Form MD5.

The entire process usually spans 3 to 4 months from start to finish.

Manufacturing License Documents Required

To streamline your application, ensure availability of the following key documents:

Company Constitution: Certificate of incorporation and business registration.
Proof of Premises Ownership: Lease agreement or ownership documents.
Technical Staff Qualifications: Details and CVs of qualified personnel.
Fire NOC & Pollution NOC: Safety clearances from local authorities.
Device Master File (DMF): Comprehensive technical dossier describing design, manufacturing, and quality controls. Our Device Master File guide explains preparation essentials.
Plant Master File (PMF): Documentation of manufacturing facility and processes. For insights, see our Plant Master File guide.
Essential Principles Checklist: Declaration of conformity with applicable standards.
Risk Management File: Risk assessment and mitigation strategies compliant with ISO 14971. Learn more about risk management.
Test Reports: Results from government-approved testing labs.
Labels and Instructions for Use (IFU): Finalized product labeling and user manuals.
Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal audit reports.

Import License Process (MD15) for Dental Prosthesis Priming Agent

If you intend to import the Dental Prosthesis Priming Agent, an MD15 import license from the Central Licensing Authority is mandatory. This process typically takes 5 to 6 months and involves:

Preparation of comprehensive documentation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate if applicable).
Application submission on the CDSCO MD Online Portal using Form MD14.
Query resolution during the review period.
Final license grant on Form MD15.

For detailed guidance, visit our Import License guide.

Import License Documents Required

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

Timeline and Processing Duration

License Type	Process Duration	Key Milestones
Test License (MD13)	1.5 - 2 months	Application approval, test lab allocation
Product Testing	2 - 4 weeks	Testing completion and report submission
MD5 License (Form MD3)	1.5 - 2 months	Application review, audit, query resolution

Total: Approximately 3 to 4 months for manufacturing license.

Government Fees and Costs

MD5 License Application Fee: Rs 5,000 per application
Product Fee: Rs 500 per product
Test License Fee (MD13): Included in application fees

Additional costs include fees paid to notified bodies for audits and charges for product testing at government-approved laboratories.

Common Challenges and Solutions

Delays in Product Testing: Scheduling with approved labs can be competitive; early booking is recommended.
Incomplete Documentation: Meticulous preparation of Device Master File and risk management documents helps avoid rejections.
Audit Non-Compliance: Pre-audit internal checks and training of facility staff reduce audit findings.
Query Resolution Delays: Prompt and detailed responses to CDSCO queries accelerate approval.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we offer tailored support including:

Preparation and review of technical files
Liaison with notified bodies and CDSCO authorities
Scheduling and guidance for product testing
Pre-audit readiness assessments

Partnering with experts ensures smoother navigation through complex regulatory pathways.

Getting Started with Your CDSCO License Application

Assess your device classification: Confirm Class B status per the Medical Device Classification.
Prepare technical documentation: Begin compiling your Device Master File and Plant Master File.
Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to commence testing.
Engage with notified bodies: Identify and schedule audits early using the Notified Bodies List.
Plan your timeline and budget: Allocate 3-4 months and budget for fees and testing costs.

Starting early and maintaining compliance at each step is key to timely licensing and market entry. Contact us today for personalized guidance on your Dental Prosthesis Priming Agent license application.

For more detailed insights on MD5 licensing, you may explore our dedicated MD5 License Guide.

CDSCO License for Dental Prosthesis Priming Agent

Medical Device Information

Intended Use