CDSCO License for Flexible video salpingoscope

Introduction to Flexible Video Salpingoscope and Its Regulatory Importance

The Flexible Video Salpingoscope is a specialized medical device used for the visual examination and treatment of the fallopian tubes (oviducts), playing a crucial role in obstetrical and gynecological care. Given its invasive use and moderate risk profile, regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing or manufacturing this device in India.

With over 25 years of experience, we have assisted 500+ companies in successfully navigating the complex CDSCO licensing landscape. Understanding the regulatory framework for your Flexible Video Salpingoscope, classified as a Class B device, is essential for timely market entry and compliance.

CDSCO Regulatory Framework for Flexible Video Salpingoscopes

The CDSCO governs medical device registration and licensing in India under the Medical Devices Rules, 2017. Flexible Video Salpingoscopes fall under the Obstetrical and Gynecological category, notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022.

As a Class B device, the regulatory oversight is stringent but manageable, involving state-level licensing authorities for manufacturing and central authorities for import licensing.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk and require an MD5 Manufacturing License issued by the State Licensing Authority. Importers must obtain an MD15 Import License from the Central Licensing Authority.

Understanding your device’s classification helps determine the exact forms, fees, and procedures required. For example, the Flexible Video Salpingoscope’s classification as Class B means:

• Manufacturing License: MD5 License (Form MD3) via State Authority
• Import License: MD15 License via Central Authority

Learn more about medical device classification on this Medical Device Classification guide.

Manufacturing License Process for Flexible Video Salpingoscope (MD5)

The manufacturing license process for Class B devices like the Flexible Video Salpingoscope typically takes 3–4 months. This process includes:

1. Test License Application (Form MD13): Initial application to manufacture the device for testing purposes; processing time is 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved government laboratories to validate safety and efficacy. A list of approved Testing Laboratories is available online.
3. Document Preparation: Compile required technical, quality, and regulatory documentation.
4. Manufacturing License Application (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body conducts an onsite audit of your manufacturing facility. Refer to the Notified Bodies List for authorized auditors.
6. Query Resolution: Address any queries raised by the notified body or CDSCO.
7. Grant of License (Form MD5): Once approved, you receive the manufacturing license.

Manufacturing License Documents Required for Flexible Video Salpingoscope

To ensure a smooth application process, prepare the following documents:

• Company Constitution (e.g., Memorandum of Association, Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details of technical staff qualifications and experience
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Our Device Master File Guide can assist in preparation.
• Plant Master File (PMF) describing the facility and quality systems; see our Plant Master File Guide
• Essential Principles Checklist demonstrating compliance with Indian medical device standards
• Risk Management File showing hazard analysis and mitigation strategies. For insights, visit our Risk Management resource.
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process for Flexible Video Salpingoscope (MD15)

For companies importing Flexible Video Salpingoscopes into India, the MD15 Import License from the Central Licensing Authority is mandatory. The process generally takes 5–6 months and involves:

1. Document Preparation: Assemble manufacturing licenses, Free Sale Certificate, ISO 13485:2016, CE certificates, device and plant master files, wholesale licenses, and company constitution.
2. License Application (Form MD14): Submit application online via the CDSCO MD Online Portal.
3. Query Resolution: Address any regulatory queries.
4. Grant of License (Form MD15): Receive the import license.

Unlike manufacturing licenses, no test license is required before applying for import.

Import License Documents Required

Key documents to prepare include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate (FSC) confirming product marketing approval
• ISO 13485:2016 certification
• CE Certificate or equivalent quality compliance certificates
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and ownership proof

Timeline and Processing Duration

Proactive document preparation and prompt query responses can significantly reduce these timelines.

Government Fees and Costs

For the Flexible Video Salpingoscope (Class B device), the fee structure is:

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product

Note: The test license (MD13) application fee is included in the process.

• MD15 Import License: Rs 2,000 per site + Rs 1,000 per product

All payments are made through the CDSCO MD Online Portal.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test Report Availability

• Solution: Engage early with CDSCO-approved testing laboratories and schedule tests well in advance.

Challenge 2: Audit Non-Compliance

• Solution: Conduct internal audits and gap analysis before the notified body visit. Use our Plant Master File and Device Master File guides to ensure compliance.

Challenge 3: Document Inconsistencies

• Solution: Standardize document templates and cross-verify data across files, labels, and QMS.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory liaison to address CDSCO or notified body queries promptly.

Expert Consultation and Support

Navigating CDSCO’s regulatory framework can be complex, particularly for Class B medical devices like Flexible Video Salpingoscopes. Our team, with 25+ years of expertise and over 500 successful licenses, offers:

• Comprehensive gap analysis
• Document preparation and review
• Coordination with testing labs and notified bodies
• End-to-end application management

Partnering with experienced consultants minimizes risks and accelerates your time to market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B via official CDSCO guidelines.
2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
3. Prepare Required Documents: Use our linked guides for Device and Plant Master Files.
4. Apply for Test License (Form MD13): Begin manufacturing for testing.
5. Schedule Product Testing: Engage with approved laboratories early.
6. Compile and Submit Manufacturing License Application (Form MD3): Include all documentation.
7. Coordinate Audit and Query Responses: Ensure readiness for notified body inspections.

Starting early and maintaining regulatory compliance will streamline your approval process. Contact us today to receive tailored support for your Flexible Video Salpingoscope CDSCO licensing journey.