CDSCO License for Pelviscope

Introduction: Understanding the Pelviscope and Its Regulatory Importance

The Pelviscope is a specialized endoscopic medical device used for the visual examination and diagnosis of the pelvis, primarily within obstetrical and gynecological applications. As a Class B medical device under the CDSCO regulatory framework, it requires a thorough compliance process to ensure safety, efficacy, and quality before entering the Indian market. Navigating these regulatory requirements can be complex, but with over 25 years of expertise and having supported 500+ companies, we provide detailed guidance to streamline your CDSCO licensing journey.

CDSCO Regulatory Framework for Pelviscope (Class B Device)

In India, medical devices like the Pelviscope fall under the purview of the Central Drugs Standard Control Organization (CDSCO). Since June 2022 (Notification File No. 29/Misc./03/2020-DC (181)), the Pelviscope is officially notified as a Class B device. This classification mandates compliance with specific manufacturing and import licensing requirements to ensure patient safety.

Risk Classification and License Requirements

The Pelviscope is classified as a Class B (Low Moderate Risk) device. This classification requires manufacturers to obtain an MD5 manufacturing license issued by the respective State Licensing Authority. Importers, on the other hand, must secure an MD15 import license from the Central Licensing Authority.

License Type for Manufacturing: MD5 License (Application Form MD3)
Regulatory Authority: State Licensing Authority
Estimated Process Duration: 3-4 months
Fees: Rs 5000 per application + Rs 500 per product

For a detailed explanation of Class A/B device licensing, please refer to our MD5 License Guide.

Manufacturing License Process for Pelviscope (MD5 License)

Obtaining an MD5 license for your Pelviscope involves several critical steps:

Test License Application (Form MD13): Begin by applying for a test license, which allows you to test your device legally. This step typically takes 1.5-2 months.
Product Testing: Conduct mandatory testing of your Pelviscope at a CDSCO-approved laboratory. You can find the list of authorized Testing Laboratories here.
Document Preparation: Compile necessary documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System documentation.
License Application (Form MD3): Submit the application for the manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing premises and QMS will be conducted by a CDSCO-recognized notified body. Review the list of notified bodies to select the appropriate auditor.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly to avoid delays.
Grant of License: Upon successful completion of all steps, the MD5 license will be granted on Form MD5.

Manufacturing License Documents Required for Pelviscope

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

Company Constitution (e.g., Incorporation Certificate)
Proof of Ownership or Lease Agreement of Manufacturing Premises
Details and Qualification Certificates of Technical Staff
Fire and Pollution No Objection Certificates (NOCs)
Device Master File (DMF) detailing design, manufacturing processes, and device specifications. Refer to our comprehensive Device Master File guide.
Plant Master File (PMF) describing the manufacturing facilities and quality controls. Learn more from our Plant Master File Guide.
Essential Principles Checklist confirming compliance with safety and performance requirements
Risk Management File in line with ISO 14971 standards. For best practices, see our Risk Management guide.
Test Reports from approved labs
Labels, Instructions for Use (IFU), and Packaging Details
Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process for Pelviscope (MD15 License)

If you are an importer of the Pelviscope, the MD15 import license application is handled by the Central Licensing Authority. The process is as follows:

Document Preparation: Gather all necessary import documentation including existing manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, and Wholesale License.
Submission of Application (Form MD14): Submit your application through the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any clarifications requested by CDSCO.
Grant of Import License (Form MD15): Once all requirements are met, the import license will be issued.

Import License Documents Required

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

Government Fees for Import License

Class B devices are charged Rs 2000 per site and Rs 1000 per product.

For a detailed overview of the import process, check our Import License Guide.

Timeline and Processing Duration

Step	Duration
Test License Application	1.5 – 2 months
Product Testing	3 – 4 weeks
Document Preparation	2 – 3 weeks
Application Submission	Immediate upon readiness
Audit and Inspection	3 – 4 weeks
Query Resolution	2 – 3 weeks
Total Estimated Time	3 – 4 months

Being proactive in document preparation and timely query resolution can significantly reduce delays.

Government Fees and Costs Breakdown

Test License (MD13): Rs 5000 per application
MD5 Manufacturing License: Rs 5000 per application + Rs 500 per product
Product Testing Costs: Variable depending on lab and test complexity (approx Rs 50,000 – Rs 1,00,000 for endoscopic devices)
Audit Fees: Paid directly to the notified body (varies, typically Rs 50,000 – Rs 1,50,000)

Budgeting accurately for these fees is critical to avoid unexpected expenses.

Common Challenges and Solutions in Pelviscope Licensing

Challenge: Delays in Product Testing

Testing can be delayed due to limited slots at CDSCO-approved labs or incomplete sample submissions.

Solution: Book your test slots early and ensure samples meet lab requirements. Refer to the Testing Laboratories list for options.

Challenge: Incomplete or Non-compliant Documentation

Missing or inadequate technical files can result in rejection or repeated queries.

Solution: Use checklists and expert reviews for your Device Master File, Plant Master File, and Risk Management File. Our guides can help ensure compliance.

Challenge: Audit Non-conformities

Manufacturing premises or QMS non-compliance may lead to audit failure.

Solution: Prepare through mock audits and ensure adherence to ISO 13485 standards.

Challenge: Prolonged Query Resolution

Delayed responses to CDSCO queries extend the licensing timeline.

Solution: Assign a dedicated regulatory coordinator to handle queries promptly.

Expert Consultation and Support

With our extensive experience supporting 500+ medical device companies, we offer end-to-end assistance including:

Gap analysis and readiness assessment
Document preparation and review
Coordination with notified bodies and testing labs
Application filing and follow-up
Audit preparation and training

Our personalized approach ensures your Pelviscope manufacturing or import license application proceeds smoothly.

Getting Started with Your CDSCO License Application for Pelviscope

Assess Your Current Compliance Status: Review your manufacturing setup, documentation, and QMS against CDSCO requirements.
Apply for Test License (Form MD13): Submit your test license application via the CDSCO MD Online Portal.
Prepare Device and Plant Master Files: Utilize our detailed guides on Device Master Files and Plant Master Files to organize comprehensive dossiers.
Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid bottlenecks.
Engage a Notified Body for Audit: Select a notified body from the official list and schedule your audit.
Submit Manufacturing License Application: Once testing and audit are complete, file the MD5 application on the online portal.
Maintain Communication: Respond to any queries promptly to expedite approval.

Embarking on your CDSCO licensing journey for the Pelviscope with a clear roadmap and expert support is key to timely market entry and regulatory compliance. Contact us to leverage our 25+ years of expertise and ensure your success in the Indian medical device market.