CDSCO License for Gynaecological Cerclage Needle

Introduction to Gynaecological Cerclage Needle and Regulatory Importance

The Gynaecological Cerclage Needle is a specialized loop-like disposable hypodermic needle used predominantly to suture the cervix during gynecological procedures. This device plays a critical role in preventing premature cervical dilation and ensuring pregnancy retention. Given its invasive nature and clinical significance, regulatory compliance under the Central Drugs Standard Control Organisation (CDSCO) is mandatory for manufacturers and importers aiming to market this device in India.

With the notification number 29/Misc/3/2017-DC (292) dated 06.06.2018, the Gynaecological Cerclage Needle is classified under Class B risk category. This classification mandates a rigorous approval process to ensure safety, efficacy, and quality.

CDSCO Regulatory Framework for Gynaecological Cerclage Needle

The CDSCO governs medical device registration and licensing in India under the Medical Device Rules 2017, aligning with global standards to safeguard public health. For Class B devices such as the Gynaecological Cerclage Needle, manufacturers must secure an MD5 manufacturing license issued by the State Licensing Authority. Importers must obtain the MD15 import license from the Central Licensing Authority.

This regulatory framework ensures that devices meet essential principles of safety, performance, and quality before entering the Indian market.

Risk Classification and License Requirements

The Gynaecological Cerclage Needle falls into Class B risk category, which includes devices with moderate risk requiring a moderate level of regulatory control. This classification necessitates:

• Manufacturing License: MD5 license (Form MD3 application) from State Licensing Authority
• Test License: MD13 license for testing before applying for manufacturing license
• Import License (if applicable): MD15 license (Form MD14 application) from Central Licensing Authority

Understanding this classification helps streamline the licensing process and ensures compliance.

Manufacturing License Process (MD5) for Class B Devices

For a Gynaecological Cerclage Needle manufacturer, the MD5 license process involves the following steps:

1. Obtain Test License (Form MD13): This preliminary step allows you to conduct product testing. The test license approval typically takes 1.5 to 2 months.

2. Product Testing: The device must be tested at CDSCO-approved government laboratories. Testing covers biocompatibility, sterility, mechanical performance, and compliance with essential principles.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) compliance, labels, and Instructions for Use (IFU).

4. Submit Application (Form MD3) on CDSCO MD Online Portal: Apply for the manufacturing license through the CDSCO MD Online Portal.

5. Audit by Notified Body: A mandatory audit by a notified body listed on the CDSCO Notified Bodies List will assess compliance with QMS and manufacturing practices.

6. Resolution of Queries: Address any queries raised by the department or notified body promptly and thoroughly.

7. Grant of License (Form MD5): Upon successful audit and review, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Gynaecological Cerclage Needle

To ensure a smooth application, the following documents must be meticulously prepared and submitted:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire and Pollution NOCs
• Device Master File (DMF) detailing device design, manufacturing process, and validation (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facility and quality control procedures (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File evidencing hazard identification and mitigation strategies (Risk Management)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories)
• Product Labels, Packaging Details, and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Gynaecological Cerclage Needle

If you are an importer of the Gynaecological Cerclage Needle, the MD15 license issued by the Central Licensing Authority is mandatory. The import license process includes:

1. Document Preparation: Compile all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.

3. Review and Queries: The CDSCO reviews the application and raises queries if needed.

4. Grant of Import License (Form MD15): Upon satisfactory review, the import license is granted.

Note that no test license is required for import applications, but the process typically takes 5-6 months.

Import License Documents Required

Key documents for import license application include:

• Valid Manufacturing License from the exporting country
• Free Sale Certificate issued by the competent authority of exporting country
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License in India
• Company Constitution and Address Proof

These documents demonstrate the legitimacy and quality compliance of the imported device.

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 2-3 weeks (varies with lab workload)
  • Application Processing & Audit: 1 to 1.5 months

• MD15 Import License: 5-6 months

Timelines may vary based on the completeness of documentation and responsiveness to queries. Early preparation and thorough documentation can expedite the process.

Government Fees and Costs

For the Gynaecological Cerclage Needle (Class B), the fee structure for manufacturing license is:

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

For import license (MD15), fees are:

• Site Fee: USD 2,000 per site
• Product Fee: USD 1,000 per product

Additional costs include testing fees at accredited labs and notified body audit charges. Budgeting for these is crucial to avoid surprises.

Common Challenges and Solutions

Challenge: Delays due to incomplete documents or audit non-compliance.

Solution: Engage experienced regulatory consultants to review your documentation against CDSCO guidelines. Use checklists and follow guides such as the MD5 License Guide.

Challenge: Difficulty in sourcing reliable notified bodies or testing labs.

Solution: Refer to the official CDSCO list of notified bodies and testing laboratories to select accredited partners.

Challenge: Managing timelines effectively.

Solution: Start early with test license application and testing, prepare documents concurrently, and maintain proactive communication with authorities.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we offer end-to-end support for manufacturing and import licensing of medical devices including Class B Gynaecological Cerclage Needles. Our services include:

• Gap analysis of existing documentation
• Device Master File and Plant Master File preparation
• Test license and manufacturing license application handling
• Coordination with notified bodies and testing labs
• Post-approval compliance and audit support

Engaging expert consultants can significantly reduce application errors, save time, and ensure regulatory compliance.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing journey for the Gynaecological Cerclage Needle, follow these practical steps:

1. Assess Device Classification: Confirm your device as Class B using the Medical Device Classification guide.

2. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal along with preliminary documents.

3. Select Accredited Testing Laboratory: Choose a CDSCO-approved lab from the official list to conduct mandatory product tests.

4. Prepare Comprehensive Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and other essential documents.

5. Engage a Notified Body: Schedule the audit with an appropriate notified body to comply with manufacturing license requirements.

6. Apply for Manufacturing License (MD5): Upon successful testing and audit, submit your manufacturing license application.

7. Resolve Queries Promptly: Maintain communication with CDSCO and notified bodies to address any questions quickly.

By following these steps and leveraging expert guidance, manufacturers and importers can confidently navigate the CDSCO licensing landscape for the Gynaecological Cerclage Needle and successfully enter the Indian market.