CDSCO License for Rigid salpingoscope

Comprehensive Guide to CDSCO License for Rigid Salpingoscope (Class B Medical Device)

As experienced regulatory consultants with over 25 years helping 500+ companies successfully navigate Indian medical device regulations, we understand the nuances of obtaining a CDSCO manufacturing license for specialized devices like the Rigid Salpingoscope. This endoscope, categorized under the obstetrical and gynecological device class and classified as a Class B medical device, requires strict adherence to the regulatory framework to ensure market access in India.

Understanding the Rigid Salpingoscope and Regulatory Importance

A rigid salpingoscope is an endoscopic instrument designed specifically for the visual examination and treatment of the fallopian tubes (oviducts). Given its critical role in gynecological diagnostics and interventions, the Indian government has classified it as a moderate-risk (Class B) device under its medical device regulations. Proper licensing via the CDSCO (Central Drugs Standard Control Organization) ensures compliance with safety and quality parameters, protecting patients and facilitating smooth market entry.

CDSCO Regulatory Framework for Rigid Salpingoscope (Class B)

The CDSCO oversees regulation of medical devices in India, categorizing devices by risk class (A, B, C, D). For Class B devices like the rigid salpingoscope, manufacturers must obtain an MD5 manufacturing license issued by the State Licensing Authority. This license confirms that the facility and the product meet all regulatory requirements, including quality management systems, product testing, and documentation.

The regulatory journey includes:

• Obtaining a Test License (Form MD13)
• Product testing at government-approved labs
• Preparation and submission of the manufacturing license application (Form MD3)
• Audit by a notified body
• Resolution of any queries
• Final grant of the MD5 license

You can initiate all electronic applications through the CDSCO MD Online Portal.

Risk Classification and License Requirements for the Rigid Salpingoscope

• Device Risk Class: B (Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Total Process Duration: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

This classification mandates a thorough audit by a notified body listed on the CDSCO Notified Bodies List to ensure compliance with Indian standards.

Manufacturing License Process for Rigid Salpingoscope

1. Apply for Test License (MD13): Before full manufacturing license application, a test license is mandatory to facilitate product testing. This typically takes 1.5 to 2 months.

2. Product Testing: The device must be tested at CDSCO-approved laboratories. You can refer to the list of Testing Laboratories accredited for medical device testing.

3. Document Preparation: Prepare all required documents including technical files, quality management system (QMS) documents, and risk management files.

4. Submit Application (Form MD3): Apply on the CDSCO MD Online Portal for the MD5 license.

5. Audit by Notified Body: The notified body performs an onsite audit of your manufacturing facility and QMS.

6. Query Resolution: Address any observations or queries raised by the notified body or CDSCO.

7. License Grant: Upon satisfactory review, the MD5 license is issued.

For detailed guidance on MD5 licensing, our MD5 License Guide is a valuable resource.

Manufacturing License Documents Required for the Rigid Salpingoscope

• Company constitution documents (Incorporation Certificate, MOA/AOA)
• Proof of premises ownership or lease agreement
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product design and specifications (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes (Plant Master File Guide)
• Essential Principles of Safety and Performance checklist
• Risk Management File documenting hazard analyses and mitigations (Risk Management)
• Product test reports from approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485 certification, SOPs, CAPA, etc.)

Import License Process (MD15) for Rigid Salpingoscope

If you are an importer of rigid salpingoscopes, obtaining an MD15 import license from the Central Licensing Authority is mandatory.

• Application Form: MD14
• License Form: MD15
• Timeline: 5-6 months
• Fees: Vary by device class; for Class B devices, typically Rs 2000/site + Rs 1000/product

Required documents include:

• Valid Manufacturing License (from country of origin)
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate
• Device and Plant Master Files
• Wholesale drug license
• Company constitution documents

The entire application is submitted via the CDSCO MD Online Portal.

For detailed import license consultancy, see our Import License Guide.

Timeline and Processing Duration

Planning your timeline accordingly can prevent costly delays.

Government Fees and Costs

• MD13 Test License Fee: Rs 5,000
• MD5 Manufacturing License Fee: Rs 5,000 per application + Rs 500 per product
• Auditing and Testing Costs: Vary depending on notified body and testing laboratory charges

Budgeting for these fees early in the process ensures smooth financial planning.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensure all files (Device Master File, Plant Master File, Risk Management) are comprehensive and up-to-date.
• Delayed Testing Reports: Choose CDSCO-approved labs with a track record of timely testing.
• Audit Non-Compliance: Conduct internal audits and gap assessments before notified body visits.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. With our extensive experience, we offer tailored consultancy to streamline your application, prepare documentation, coordinate testing, and manage audits. Our proactive approach reduces approval time and mitigates risks associated with non-compliance.

Getting Started with Your CDSCO License Application for Rigid Salpingoscope

1. Assess your device classification and licensing needs: Confirm your device is Class B and requires an MD5 license.
2. Register on the CDSCO MD Online Portal: Set up your account for electronic submissions.
3. Prepare your Device Master File and Plant Master File: Use our guides to ensure completeness.
4. Apply for the Test License (Form MD13): Initiate product testing phase.
5. Engage with a notified body early: Schedule your audit to coincide with your documentation readiness.
6. Maintain open communication: Respond swiftly to CDSCO queries to avoid delays.

By following these steps and leveraging expert guidance, manufacturers and importers of rigid salpingoscopes can confidently achieve CDSCO compliance and successfully launch their products in the Indian market.