CDSCO License for Enucleation scissors

Comprehensive Guide to CDSCO Licensing for Enucleation Scissors (Class A Medical Device)

Enucleation scissors are specialized ophthalmic surgical instruments designed for precise cutting of tissue during eye surgeries, particularly enucleation procedures. Classified as a Class A medical device, these hand-held, manual scissors fall under the lowest risk category but still require strict regulatory compliance to ensure patient safety and quality standards. For manufacturers and importers looking to enter the Indian market, obtaining the appropriate Central Drugs Standard Control Organization (CDSCO) license is crucial.

With over 25 years of experience and having assisted more than 500 companies in navigating CDSCO licensing, we provide a detailed, step-by-step guide specifically for enucleation scissors under the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

CDSCO Regulatory Framework for Enucleation Scissors

Enucleation scissors fall under the ophthalmology category and are classified as Class A devices according to the CDSCO medical device classification system. This classification impacts the licensing pathway, regulatory requirements, and the authority responsible for granting the license.

The CDSCO framework mandates compliance with the Medical Device Rules (MDR) 2017 and subsequent amendments, which require manufacturers and importers to obtain manufacturing or import licenses before marketing such devices in India.

Risk Classification and License Requirements for Enucleation Scissors

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Form MD3) for manufacturers
• Regulatory Authority: State Licensing Authority

For Class A devices like enucleation scissors, the State Licensing Authority grants the manufacturing license. Importers must obtain an MD15 Import License from the Central Licensing Authority.

Manufacturing License Process (MD5) for Enucleation Scissors

The process to obtain an MD5 license for Class A devices involves several precise steps:

1. Obtain Test License (Form MD13): Before the manufacturing license, manufacturers must apply for a test license to conduct product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: The device samples must be tested at government-approved testing laboratories to ensure compliance with essential quality and safety standards. Detailed information on testing labs is available on the CDSCO Testing Laboratories list.
3. Prepare Documentation: Compile all necessary documents such as Device Master File, Plant Master File, Technical Staff credentials, and Quality Management System (QMS) documents.
4. Application Submission: Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct a factory audit to verify compliance with MDR requirements. The list of Notified Bodies can be referenced.
6. Resolve Queries: Address any queries or observations raised during the audit or application review.
7. License Grant: Upon successful evaluation, the MD5 license (Form MD5) is granted.

Manufacturing License Documents Required

The following documents are essential for a smooth application process:

• Company Constitution (e.g., Partnership Deed, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement for the manufacturing premises
• Details and qualifications of technical staff involved in manufacturing
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing the facility and equipment (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File documenting risk identification and mitigation (Risk Management Guide)
• Test Reports from government-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Enucleation Scissors

While the manufacturing license is issued by the State Authority, importers must secure the MD15 Import License from the Central Licensing Authority. For Class A devices:

1. Documentation Preparation: Gather all documents including Manufacturing License, Free Sale Certificate, ISO 13485, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.
2. Application Submission: File the application via the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Address any department queries promptly.
4. License Grant: The MD15 license is granted typically within 5-6 months.

Import License Documents Required

• Manufacturing License of the device from the country of origin
• Free Sale Certificate issued by the regulatory authority of the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 License:

  • Application Fee: INR 5,000
  • Product Fee: INR 500 per product

• MD15 Import License:

  • Site Fee (Class A): USD 1,000 (~INR 75,000)
  • Product Fee (Class A): USD 50 (~INR 3,750) per product

Additional costs include fees for testing, notified body audits, and consultants’ charges if expert help is engaged.

Common Challenges and Solutions

• Delayed Testing Results: Selecting government-approved labs with shorter turnaround times can mitigate delays.
• Incomplete Documentation: Use comprehensive checklists such as our detailed Device Master File guide to ensure completeness.
• Audit Non-Compliance: Pre-audit internal assessments and mock audits can prepare manufacturers for notified body inspections.
• Query Resolution Delays: Assign dedicated personnel to monitor and respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for first-time applicants. Our regulatory consultants bring decades of experience in:

• Preparing and reviewing Device Master Files and Plant Master Files
• Coordinating product testing with notified laboratories
• Managing audit readiness and compliance
• Liaising with CDSCO authorities to expedite application processing

Engaging expert support can reduce timelines, avoid costly rejections, and ensure regulatory compliance.

Getting Started with Your CDSCO License Application for Enucleation Scissors

1. Initiate Early Testing: Apply for the test license (MD13) immediately to start product testing.
2. Prepare Documentation: Simultaneously, assemble all required documents, leveraging our Plant Master File guide and risk management resources.
3. Register on CDSCO Portal: Create an account and submit initial applications via the CDSCO MD Online Portal.
4. Plan for Audit: Schedule internal audits and corrective actions before notified body inspections.
5. Monitor Application Status: Regularly track your application and respond promptly to queries.

By following these actionable steps and leveraging our expertise, manufacturers and importers of enucleation scissors can confidently navigate the regulatory landscape and successfully enter the Indian market.

For tailored support and detailed consultation, reach out to our regulatory team and accelerate your CDSCO licensing journey.