CDSCO License for Proctoscope, single-use

Comprehensive Guide to CDSCO Licensing for Single-Use Proctoscopes (Class B Medical Device)

The Proctoscope, single-use, is a sterile, rigid endoscopic device designed for visual examination and treatment of the rectum and anus, falling under the gastroenterology category. As a Class B medical device notified under 29/Misc./03/2020-DC (182) dated 27.09.2021, it requires specific regulatory approvals from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and import in India.

With over 25 years supporting 500+ companies in navigating CDSCO licensing, we provide you with a detailed, step-by-step roadmap to efficiently secure your MD5 manufacturing license and understand the entire regulatory framework for this device.

CDSCO Regulatory Framework for Single-Use Proctoscope (Class B Device)

The CDSCO regulates medical devices based on risk classification. Your single-use proctoscope is classified as Class B, indicating low to moderate risk. According to the Medical Device Classification guidelines, Class B devices require licensing from the State Licensing Authority via the MD5 license.

The regulatory framework includes:

• Obtaining a Test License (Form MD13) for product testing
• Conducting product testing at CDSCO-approved labs
• Preparing technical documentation including Device Master File and Plant Master File
• Submission of application for Manufacturing License (Form MD3)
• Audit by a notified body
• Resolution of queries and final grant of MD5 license (Form MD5)

Risk Classification and License Requirements for Proctoscope

Being a Class B device, the proctoscope requires an MD5 license, which is granted by the State Licensing Authority after successful audit and documentation review.

Manufacturing License Process for Single-Use Proctoscope (MD5 License)

1. Apply for Test License (Form MD13): Submit application on the CDSCO MD Online Portal to obtain a test license. This allows you to conduct mandatory product testing.
2. Product Testing: Conduct testing of the proctoscope at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing typically takes 1-2 months.
3. Prepare Documentation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. Submit Application for MD5 License (Form MD3): Upload the complete dossier to the MD Online Portal.
5. Audit by Notified Body: The notified body will audit your manufacturing site and documents. Refer to the List of Notified Bodies to select an authorized auditor.
6. Resolve Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the MD5 manufacturing license.

For a detailed walkthrough, our MD5 License Guide offers comprehensive insights.

Manufacturing License Documents Required for Proctoscope

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, manufacturing process (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facility and infrastructure (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance
• Risk Management File following ISO 14971 guidelines (Risk Management Guide)
• Valid Test Reports from CDSCO approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification is advantageous)

Import License Process for Single-Use Proctoscope (MD15 License)

If you are an importer rather than manufacturer, obtaining the MD15 import license from the Central Licensing Authority is mandatory.

Steps include:

1. Prepare dossier including manufacturing license of the exporter, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
2. Submit application on the CDSCO MD Online Portal.
3. Respond to any queries from the authority.
4. Await grant of Import License (Form MD15), typically within 5-6 months.

Refer to our Import License Guide for detailed steps.

Import License Documents Required

• Manufacturer’s valid Manufacturing License
• Free Sale Certificate issued by country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Importer’s PAN/ GST documents

Timeline and Processing Duration

Manufacturers often underestimate cumulative timelines; starting early with documentation and lab testing can save months.

Government Fees and Costs for Proctoscope MD5 License

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

Additional costs to consider include:

• Testing fees charged by laboratories (varies by test complexity)
• Notified body audit fees
• Documentation preparation and consulting fees

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved labs early to schedule tests. Consider multiple labs to avoid bottlenecks.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use standardized templates for DMF, PMF, and risk management files. Our guides provide ready-to-use checklists.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits ahead of notified body visits to identify gaps.

Challenge 4: Misclassification of Device

• Solution: Verify device classification with expert consultants or via the official CDSCO classification list.

Expert Consultation and Support

Our team has facilitated over 500 successful CDSCO licensing projects for devices similar to your proctoscope. We offer:

• Pre-submission regulatory strategy
• Complete documentation preparation
• Coordination with testing labs and notified bodies
• End-to-end application filing on the CDSCO MD Online Portal
• Post-license compliance support

Our experience ensures minimized delays and maximized compliance.

Getting Started with Your CDSCO License Application for Single-Use Proctoscope

1. Confirm Device Classification: Verify your proctoscope’s Class B status per CDSCO guidelines.
2. Register on CDSCO MD Online Portal: Create an account to initiate your test license application.
3. Prepare Preliminary Documentation: Gather company constitution, premises proof, and staff details.
4. Apply for Test License (Form MD13): Submit early to allow time for product testing.
5. Select CDSCO-Approved Testing Laboratory: Arrange product testing promptly upon license grant.
6. Develop Device and Plant Master Files: Use our detailed guides to prepare these critical files.
7. Schedule Notified Body Audit: Identify and book audit dates through the notified bodies list.
8. Submit MD5 License Application (Form MD3): After successful testing and documentation readiness.

Starting your application now positions you ahead of competitors in the growing Indian gastroenterology market. For personalized assistance, reach out to our expert team to streamline your CDSCO licensing journey.

By adhering to this comprehensive process and leveraging our 25+ years of regulatory expertise, your single-use proctoscope will confidently meet Indian regulatory standards and reach healthcare providers nationwide.

For more detailed insights, visit our MD5 License Guide or contact our regulatory consultants today.