CDSCO License for Face shield

Introduction to Face Shield Medical Device and Regulatory Importance

Face shields are essential Personal Protective Equipment (PPE) designed to protect the wearer’s face from chemical splashes, infectious materials, and other hazards. Particularly vital in medical, laboratory, and industrial settings, face shields play a critical role in infection control and user safety. Given their intended use and exposure to potential hazards, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers in India.

Navigating the CDSCO licensing framework for face shields, classified as Class A medical devices, can be complex without expert guidance. We have assisted over 500 companies in successfully obtaining CDSCO licenses, providing practical insights into timelines, documentation, and regulatory nuances specific to face shields.

CDSCO Regulatory Framework for Face Shields (Class A Medical Devices)

Face shields fall under Class A, the lowest risk category in India’s medical device classification system. CDSCO regulates these devices through a state-level licensing process under the Medical Device Rules (MDR) 2017, notified vide File No. 29/Misc./03/2020-DC (186) dated 13.9.2021.

The main regulatory requirement for manufacturing face shields is obtaining the MD5 manufacturing license, which ensures compliance with quality, safety, and labeling standards. The MD5 license application is submitted to the State Licensing Authority via the CDSCO MD Online Portal.

Risk Classification and License Requirements for Face Shields

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Regulatory Authority: State Licensing Authority
• Additional License: Test license (Form MD13) required prior to manufacturing license application

Face shields, being Class A, benefit from a streamlined yet thorough approval process involving product testing, documentation, and audit by a Notified Body. For detailed classification guidance, refer to our Medical Device Classification resource.

Manufacturing License Process for Face Shields (MD5 License)

The MD5 license process involves several well-defined steps:

1. Apply for Test License (Form MD13): This preliminary license allows sample production for testing.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with prescribed standards. A list of Testing Laboratories is available on the CDSCO portal.
3. Document Preparation: Compile required documents including Device Master File (DMF), Plant Master File (PMF), essential principles checklist, and risk management files.
4. Submit Application for MD5 License (Form MD3): File your application online via the CDSCO portal.
5. Notified Body Audit: Engage a notified body from the CDSCO notified bodies list for a manufacturing site audit.
6. Respond to Queries: Address any observations raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory compliance, the manufacturing license is issued.

Manufacturing License Documents Required for Face Shields

Successful MD5 license applications hinge on thorough, accurate documentation. Key documents include:

• Company Constitution: Incorporation certificate, memorandum, and articles of association.
• Proof of Premises Ownership or Lease: Valid ownership documents or lease agreements.
• Technical Staff Details: Qualification and experience certificates for technical personnel.
• Fire NOC and Pollution Control NOC: Compliance certificates from respective authorities.
• Device Master File (DMF): Detailed device specifications, design, manufacturing process, and quality control measures. Learn how to create a robust DMF in our Device Master File guide.
• Plant Master File (PMF): Details on manufacturing facility, equipment, utilities, and environmental controls. See our Plant Master File Guide for practical tips.
• Essential Principles Checklist: Demonstrating compliance with Indian Medical Device Rules.
• Risk Management File: Evidence of risk assessment and mitigation strategies aligned with ISO 14971 standards.
• Test Reports: Certificates from CDSCO-approved labs confirming product conformity.
• Labels and Instructions for Use (IFU): Samples demonstrating compliance with labeling regulations.
• Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs.

Import License Process for Face Shields (MD15 License)

For importers, obtaining the MD15 license is mandatory before marketing face shields in India. The process involves:

• Preparing comprehensive documentation including manufacturing license, Free Sale Certificate, CE Certificate, and QMS certifications.
• Applying through the CDSCO MD Online Portal using Form MD14.
• Addressing any queries raised during the review.
• Awaiting grant of MD15 import license.

The MD15 license process typically takes 5-6 months and is handled by the Central Licensing Authority. Our Import License Guide provides detailed step-by-step insights.

Timeline and Processing Duration for Face Shield Licensing

We recommend initiating the test license application promptly to avoid delays. Coordinating product testing and document preparation concurrently can optimize overall timelines.

Government Fees and Costs for Face Shield MD5 License

• Test License Fee (MD13): Rs. 5000 (approx.)
• MD5 Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product
• Notified Body Audit Charges: Variable, typically Rs. 50,000 – 1,00,000 depending on audit scope

Budgeting for notified body audits and testing fees upfront is critical to avoid unexpected expenses.

Common Challenges and Practical Solutions

• Delayed Testing Results: Choose CDSCO-approved laboratories with proven turnaround times. Engage labs early during test license approval.
• Incomplete Documentation: Use our comprehensive Device Master File and Plant Master File templates to ensure completeness.
• Audit Non-Compliance: Prepare your manufacturing site with mock audits and gap assessments prior to notified body visits.
• Query Delays: Maintain prompt communication with CDSCO and keep technical teams ready to respond.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and 500+ successful CDSCO licenses, we provide tailored support for face shield manufacturers:

• End-to-end license application assistance
• Document preparation and gap assessments
• Liaison with CDSCO and notified bodies
• Training on risk management and QMS compliance

Our proven track record makes us a trusted partner for navigating the complexities of the Indian medical device regulatory landscape.

Getting Started with Your CDSCO License Application for Face Shields

1. Register on the CDSCO MD Online Portal: Create your company profile and access application forms.
2. Apply for the Test License (Form MD13): Initiate product testing permissions.
3. Select CDSCO-Approved Testing Laboratories: Coordinate sample testing schedules.
4. Prepare Required Documentation: Utilize expert guides for DMF and PMF.
5. Engage a Notified Body Early: Schedule your audit to align with license application timelines.
6. Submit MD5 Application (Form MD3): After successful testing, file your license application.
7. Respond Promptly to Queries: Ensure timely communication to avoid processing delays.

Taking these actionable steps with expert support will position your face shield product for timely market entry and regulatory compliance in India.