CDSCO License for Gynaecological scissors, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Gynaecological Scissors (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience assisting 500+ medical device companies, we understand the unique challenges manufacturers and importers face in navigating the Indian regulatory landscape. This guide focuses on the CDSCO licensing process for reusable gynaecological scissors, a Class B medical device under the Obstetrical and Gynecological category, notified under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022.

Introduction: Understanding Your Medical Device and Its Regulatory Importance

Reusable gynaecological scissors are precision surgical instruments designed specifically to cut tissues during gynaecological surgeries. Importantly, they are not intended for obstetric use, a distinction that affects classification and regulatory requirements. Given their critical role in patient safety and clinical outcomes, adherence to the CDSCO (Central Drugs Standard Control Organization) regulatory framework is mandatory for market authorization in India.

CDSCO Regulatory Framework for Reusable Gynaecological Scissors

The CDSCO regulates medical devices as per the Medical Devices Rules, 2017, which categorize devices into four risk classes (A to D). Your device, being Class B, involves moderate risk, thus requiring a Manufacturing License (MD5) issued by the State Licensing Authority.

To initiate this, manufacturers must comply with all regulatory steps, including obtaining a Test License (MD13), product testing, audits by notified bodies, and submission of comprehensive documentation through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Moderate risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Key Regulatory Milestones:
  • Test License (MD13)
  • Product Testing at approved laboratories
  • Audit by Notified Body
  • Final License Grant (MD5)

Detailed guidance on medical device classification is available in our Medical Device Classification resource.

Manufacturing License Process for MD5 (Class B Devices)

1. Apply for Test License (MD13): This initial step enables you to manufacture a limited quantity of devices for testing. Processing time is approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved laboratories. Refer to the Testing Laboratories list for recognized facilities.
3. Prepare and Submit Documents: Compile all required documentation.
4. Application Submission: Submit your MD5 application (Form MD3) via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit assesses your manufacturing facility's compliance with quality and regulatory standards. Check the Notified Bodies list.
6. Respond to Queries: Address any questions or deficiencies identified by the notified body or licensing authority.
7. License Issuance: Upon successful completion, the MD5 license is granted.

For an in-depth step-by-step process, consult our MD5 License Guide.

Manufacturing License Documents Required for Reusable Gynaecological Scissors

Preparing a robust documentation package is critical. The key documents include:

• Company Constitution: Incorporation certificate, partnership deed, or equivalent
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Details: Qualification and experience certificates of personnel involved in manufacturing
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed product design, specifications, and performance data. See our Device Master File guide.
• Plant Master File (PMF): Details of manufacturing facilities and quality systems. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrates compliance with Indian medical device standards
• Risk Management File: Including hazard analysis and mitigation measures. For best practices, see Risk Management.
• Test Reports: From government-approved labs
• Labels and Instructions for Use (IFU): Compliant with CDSCO requirements
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and supporting documents

Import License Process (MD15) – For Importers of Reusable Gynaecological Scissors

If you are an importer rather than a manufacturer, you must obtain an MD15 license from the Central Licensing Authority. The process typically takes 5-6 months and does not require a test license.

Steps include:

• Document preparation
• Application submission using Form MD14 on the CDSCO MD Online Portal
• Resolution of any queries raised
• License grant (MD15)

Key documents required:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution

For detailed guidance, our Import License Guide elaborates on all steps and documentation.

Timeline and Processing Duration

Being proactive with documentation and audit readiness can reduce delays significantly.

Government Fees and Costs

• MD5 License Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

Additional costs to consider:

• Testing fees at approved laboratories (varies by test scope)
• Notified body audit fees (varies by body)
• Consultancy fees if engaging experts

Careful budgeting for these expenses is essential to avoid unexpected financial hurdles.

Common Challenges and Solutions

• Incomplete or inconsistent documentation: Maintain detailed checklists and use templates for Device and Plant Master Files.
• Delays in product testing: Plan testing schedules early and select accredited labs with faster turnaround times.
• Audit non-compliance: Conduct internal pre-audits and corrective action plans.
• Query resolution delays: Assign dedicated regulatory personnel for prompt responses.

Our practical experience emphasizes early preparation and continuous communication with CDSCO and notified bodies to streamline the process.

Expert Consultation and Support

Given the complexities involved, expert guidance is invaluable. Our consultants have successfully supported over 500 manufacturers and importers in obtaining CDSCO licenses for Class B devices like reusable gynaecological scissors. We provide:

• Comprehensive document preparation
• Pre-audit readiness assessments
• Liaison with CDSCO and notified bodies
• Training on regulatory compliance

Getting Started with Your CDSCO License Application

If you manufacture reusable gynaecological scissors, your first actionable step is to apply for the Test License (Form MD13) through the CDSCO MD Online Portal. Simultaneously, begin assembling your Device Master File and Plant Master File to meet documentation standards.

For importers, ensure your foreign manufacturing licenses and certifications are up to date and initiate the MD15 application process accordingly.

Engage early with a notified body from the CDSCO list to schedule audits and align timelines.

For personalized support and to avoid common pitfalls, reach out to experienced regulatory consultants who can tailor solutions to your device and business model.

By following these steps diligently, you can achieve timely approval and confidently launch your reusable gynaecological scissors in the Indian market.

We invite you to connect with us for expert consultation and to leverage our extensive regulatory expertise in navigating CDSCO licensing for Class B medical devices.