CDSCO License for Pliers

Comprehensive Guide to CDSCO Licensing for Class A Orthodontic Pliers

Pliers, especially those used in orthodontics for holding, bending, or cutting wires such as wire bending pliers, cerclip pliers, and locking pliers, fall under Class A medical devices as per the CDSCO classification. These instruments categorized under General Hospital or Orthopaedic Instruments require proper regulatory compliance to ensure safe and effective use. With the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, the regulatory framework has been clearly outlined by CDSCO for these devices.

At our firm, leveraging over 25 years of experience and a track record of assisting 500+ companies, we provide comprehensive support to navigate the entire licensing process efficiently.

CDSCO Regulatory Framework for Class A Orthodontic Pliers

Pliers intended for orthodontic use are regulated as Class A devices under the Medical Device Rules, 2017. This denotes a low-risk classification, and accordingly, the regulatory pathway involves obtaining an MD5 manufacturing license from the State Licensing Authority. The process ensures that the devices meet essential safety and quality standards before entering the Indian market.

Risk Classification and License Requirements

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Form MD3 application)
• Authority: State Licensing Authority
• Notification Reference: 29/Misc./03/2020-DC (193)- Part-3
• Intended Use: Holding, bending, cutting orthodontic wires

Manufacturers must first secure a test license and complete product testing before applying for the MD5 license.

Manufacturing License Process (MD5)

1. Test License Application (Form MD13): Initiate the process by applying for a test license, allowing you to manufacture devices for testing purposes.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate compliance with standards.
3. Documentation Preparation: Prepare a comprehensive dossier including Device Master File, Plant Master File, and risk management documents.
4. MD5 License Application (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: The State Licensing Authority will arrange an audit through an approved notified body to verify compliance.
6. Query Resolution: Address any queries raised by the department or notified body promptly.
7. Grant of License: Upon successful audit and document verification, the manufacturing license (Form MD5) is granted.

For detailed guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required

For Class A orthodontic pliers, ensure the following documents are prepared and submitted:

• Company constitutional documents (Incorporation certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire safety and pollution control NOCs
• Device Master File (DMF) detailing design and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) detailing manufacturing infrastructure (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with regulatory requirements
• Risk Management File showcasing identified risks and mitigation strategies (Risk Management)
• Test reports from CDSCO notified laboratories (Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (e.g., ISO 13485 certification)

Import License Process (MD15) for Pliers

Though your product is Class A and manufactured domestically, importers of similar devices must obtain an MD15 import license. The process involves submitting comprehensive documentation, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE mark if applicable, and other technical files.

The import license application is submitted through the CDSCO MD Online Portal and processed by the Central Licensing Authority, typically taking 5-6 months.

For further insights, our Import License Guide covers detailed steps.

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab workload
• MD5 License Application & Audit: 1.5 to 2 months
• Total Duration: Roughly 3 to 4 months from test license application to manufacturing license grant

Government Fees and Costs

• Test License (Form MD13): No separate fee; included in the overall process
• MD5 License Application Fee: INR 5,000 per application
• Product Fee: INR 500 per product
• Audit & Testing Costs: Variable based on notified body and testing lab fees

We recommend budgeting an additional 15-20% of the government fees for professional consultancy and document preparation services to avoid costly delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files such as Device Master File and Risk Management File are complete and aligned with CDSCO requirements.
• Delays in Testing: Plan for testing early as notified labs can have backlogs; check the current list of Testing Laboratories to select the fastest option.
• Audit Non-Compliance: Pre-audit internal inspections help identify and rectify gaps.
• Query Management: Respond to CDSCO queries promptly with clear evidence to avoid prolonged processing.

Expert Consultation and Support

With 25+ years in regulatory consulting and over 500 successful CDSCO license acquisitions, we offer end-to-end support:

• Gap analysis of existing documentation
• Preparation and review of Device and Plant Master Files
• Coordination with notified bodies (Notified Bodies List)
• Application submission and follow-up
• Query resolution and audit support

Our clients benefit from streamlined processes, reduced approval time, and regulatory peace of mind.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm that your pliers fall under Class A per the Medical Device Classification.
2. Prepare Key Documents: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License: Register and submit your test license application via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Schedule testing with a CDSCO-approved laboratory.
5. Plan for Audit: Contact a notified body early to arrange the mandatory audit.
6. Submit MD5 Application: Once test reports and documentation are ready, file your manufacturing license application.

Starting early and engaging expert support can significantly reduce your timeline and ensure compliance. We invite you to contact us for a personalized consultation to help you successfully launch your Class A orthodontic pliers in the Indian market.