CDSCO License for Scissor

Comprehensive Guide to CDSCO Licensing for Class A Scissors

Manufacturers and importers of medical scissors, classified as Class A devices under the CDSCO framework, must navigate a detailed regulatory process to legally market their products in India. As industry veterans with over 25 years of experience supporting more than 500 companies, we provide you with precise, actionable insights to secure your CDSCO license efficiently.

Introduction: Scissors as Medical Devices and Regulatory Significance

Scissors intended for cutting medical materials like gauze fall under the category of General Hospital or Orthopaedic Instruments. Classified as Class A (low risk) devices, these instruments require regulatory oversight to ensure safety, quality, and compliance with Indian medical device regulations. The CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022 specifically lists scissors under this category, confirming their regulatory classification.

CDSCO Regulatory Framework for Scissors (Class A Medical Devices)

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. For Class A devices like scissors, the regulatory responsibility lies with the State Licensing Authority. The process focuses on ensuring manufacturers meet Good Manufacturing Practices (GMP), quality standards, and device safety requirements.

Risk Classification and License Requirements

• Device: Scissors
• Risk Class: A (Low risk)
• Intended Use: Cutting medical materials such as gauze
• Applicable License: MD5 Manufacturing License (under Form MD3)

Class A devices require an MD5 license granted by the State Licensing Authority. This includes obtaining a Test License (Form MD13) first, followed by product testing, documentation submission, audit by a notified body, and finally, license issuance.

Manufacturing License Process for Scissors (MD5 License)

1. Apply for Test License (Form MD13): This license allows initial product testing. Expect processing times of 1.5 to 2 months.
2. Product Testing: Conduct testing at a CDSCO-approved laboratory. Refer to the List of Testing Laboratories for authorized facilities.
3. Documentation Preparation: Compile required documents including Device Master File and Plant Master File.
4. Application Submission (Form MD3): Submit your complete manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body will conduct a facility audit. Check the List of Notified Bodies to select an accredited auditor.
6. Resolution of Queries: Address any queries from the licensing authority or notified body promptly.
7. Grant of License: Upon successful review and audit, the MD5 license will be issued.

Manufacturing License Documents Required

• Company Constitution (Certificate of Incorporation, Memorandum and Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) – Detailed technical documentation of the scissors. Our Device Master File guide provides comprehensive instructions.
• Plant Master File (PMF) – Describes manufacturing processes and quality systems. See our Plant Master File Guide.
• Essential Principles Checklist ensuring compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation (refer to our Risk Management resource)
• Test Reports from CDSCO-approved labs
• Label and Instructions for Use (IFU) samples
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process (MD15 License) for Scissors

If you are an importer of scissors, you must secure an MD15 license granted by the Central Licensing Authority. Unlike manufacturing, import licensing does not require a test license but involves rigorous document scrutiny.

Key steps include:

• Document preparation including manufacturing license of foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
• Application submission via the CDSCO MD Online Portal.
• Resolution of any queries raised.
• License issuance typically within 5-6 months.

For full import licensing details, consult our Import License Guide.

Import License Documents Required

• Valid manufacturing license of the foreign manufacturer
• Free Sale Certificate (FSC) from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

• MD5 Manufacturing License: Total 3-4 months (including 1.5-2 months for test license and product testing)
• MD9 License (for Class C/D devices): 4-5 months (not applicable here)
• MD15 Import License: 5-6 months

Timely preparation and submission of documents, prompt responses to queries, and selecting notified bodies with minimal backlog can significantly reduce processing times.

Government Fees and Costs

• MD5 License Fees:
  • Rs 5,000 per application
  • Rs 500 per product (scissors as one product)

These fees are payable to the State Licensing Authority during application submission.

Common Challenges and Practical Solutions

• Delayed Test Reports: Choose well-established CDSCO-approved labs with proven turnaround times. Early appointment can reduce delays.
• Incomplete Documentation: Use detailed checklists to avoid omissions. Our Device and Plant Master File guides help streamline preparation.
• Audit Non-compliance: Conduct pre-audit internal reviews using notified body criteria to ensure readiness.
• Query Resolution Delays: Assign dedicated personnel for regulatory communications to respond swiftly.

Expert Consultation and Support

Navigating CDSCO licensing can be intricate, especially with evolving regulations. Our team of regulatory consultants, having facilitated over 500 successful approvals, offers:

• Comprehensive document preparation
• Liaison with CDSCO and notified bodies
• Pre-audit readiness assessments
• Customized timelines and cost management

Partnering with experts reduces risk of rejection and accelerates market entry.

Getting Started with Your CDSCO License Application for Scissors

1. Assess your device classification to confirm Class A status. Our Medical Device Classification resource is a helpful tool.
2. Register on the CDSCO MD Online Portal to initiate your application.
3. Engage an accredited testing laboratory early to schedule product testing.
4. Prepare detailed Device and Plant Master Files using expert templates.
5. Apply for Test License (Form MD13) to comply with regulatory prerequisites.
6. Plan for notified body audit by selecting a suitable agency from the Notified Bodies List.
7. Maintain clear records and documentation to expedite query resolution.

For manufacturers and importers aiming to launch scissors in the Indian market, early planning and expert collaboration are key. Reach out to our regulatory consulting team to ensure your CDSCO license application is smooth, compliant, and timely.

By following this comprehensive roadmap, your Class A medical scissors will achieve CDSCO licensing with confidence and minimal hassle. Contact us today to leverage our 25+ years of regulatory expertise.