CDSCO License for Rectoscope, reusable

Introduction to CDSCO Licensing for Reusable Rectoscopes

Reusable rectoscopes are specialized rigid endoscopic devices designed for the visual examination and treatment of the rectum and anus. Classified under gastroenterology, these devices fall under Class B risk category as per CDSCO regulations. Given their invasive nature and direct patient contact, securing appropriate regulatory approvals is critical to ensure safety, efficacy, and compliance for market entry in India.

At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the nuances involved in acquiring CDSCO licenses for such devices. This guide offers a detailed roadmap to obtaining your CDSCO manufacturing and import licenses specifically for reusable rectoscopes.

CDSCO Regulatory Framework for Reusable Rectoscopes

The Central Drugs Standard Control Organization (CDSCO) governs medical device approvals in India. For reusable rectoscopes, the key regulatory requirement is compliance with the Medical Device Rules, 2017, as amended by the notification 29/Misc./03/2020-DC (182) dated 27.09.2021.

The device is categorized under Class B, which implicates moderate risk and mandates a State licensing authority approval for manufacturing and Central authority for imports.

Risk Classification and License Requirements for Rectoscopes

• Risk Class: B (Moderate risk)
• License for Manufacturing: MD5 License (Form MD3 application)
• License for Import: MD15 License (Form MD14 application)

The classification influences the authority you apply to and the complexity of the approval process. Class B devices like reusable rectoscopes require a test license (MD13) prior to manufacturing license application.

Manufacturing License Process for Rectoscopes (MD5 License)

The manufacturing license process for a Class B device such as a reusable rectoscope involves several sequential steps:

1. Test License Application (Form MD13): Apply for a test license via the CDSCO MD Online Portal to legally manufacture samples for testing.
2. Product Testing: Conduct mandatory testing at CDSCO recognized testing laboratories. Refer to the approved testing laboratories list for selection.
3. Document Preparation: Compile the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and other quality system documents.
4. License Application (Form MD3): Submit the manufacturing license application through the online portal.
5. Audit by Notified Body: Engage an authorized notified body from the list of notified bodies for factory audit and product conformity verification.
6. Queries Resolution: Respond promptly to any queries from CDSCO or the notified body.
7. License Grant: Upon satisfactory evaluation, the State Licensing Authority issues the MD5 manufacturing license.

Timeline

• Test License (MD13): 1.5 to 2 months
• Testing and Documentation: 1 to 1.5 months
• Audit and License Processing: 1 to 1.5 months Total: Approximately 3 to 4 months

Costs

• Government fees: ₹5,000 per MD5 application
• Product fee: ₹500 per product
• Additional costs: Testing laboratory fees (varies by lab), audit fees payable to notified body

Manufacturing License Documents Required for Rectoscopes

• Company Constitution (Incorporation Certificate, Partnership Deed)
• Proof of ownership/lease of manufacturing premises
• Technical staff qualification documents (Bachelors/Diploma in relevant fields)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (learn more here)
• Plant Master File (PMF) covering facility details and quality management system (see guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File applying ISO 14971 principles (risk management insights)
• Test Reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 compliant)

Import License Process for Reusable Rectoscopes (MD15 License)

For importers of reusable rectoscopes, the MD15 license is mandatory and issued by the Central Licensing Authority. The process entails:

1. Document Preparation: Compile manufacturing license of manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: Submit Form MD14 on the CDSCO MD Online Portal.
3. Queries Resolution: Address any departmental clarifications quickly.
4. License Grant: Receive the import license (Form MD15).

Timeline

• Entire process typically takes 5 to 6 months.

Costs

• Government fees for Class B devices: $2,000 per site +$1,000 per product

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate issued by the competent authority of the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License of the Indian importer
• Company Constitution documents

Common Challenges and Solutions

• Delayed Testing Results: To avoid bottlenecks, select CDSCO-recognized laboratories with proven turnaround times.
• Incomplete Documentation: Use comprehensive checklists and templates for DMF, PMF, and risk files to prevent back-and-forth with CDSCO.
• Notified Body Audit Scheduling: Plan audits well in advance, especially since availability of notified bodies can be limited.
• Query Management: Assign experienced regulatory personnel to respond diligently to CDSCO and notified body queries.

Our hands-on experience has helped manufacturers navigate these challenges effectively, ensuring smoother approvals.

Expert Consultation and Support

With a track record of assisting over 500 medical device companies, our expert team provides:

• Detailed gap analysis for your current documentation
• Tailored audit readiness preparation
• End-to-end application filing and follow-up
• Liaison with CDSCO authorities and notified bodies

Our clients appreciate our pragmatic approach, which significantly reduces approval timelines and avoids costly rejections.

Getting Started with Your CDSCO License Application for Reusable Rectoscopes

1. Assess Your Device Classification: Confirm your device is Class B and prepare accordingly.
2. Register on the CDSCO MD Online Portal: Create your account to access all application forms and upload documents.
3. Initiate Test License Application (MD13): Begin manufacturing samples for mandatory testing.
4. Engage Accredited Testing Labs: Schedule product testing early to avoid delays.
5. Prepare Master Files and QMS Documents: Use industry best practices and templates.
6. Schedule Notified Body Audit: Choose from the list of notified bodies and book audits in advance.
7. Submit Manufacturing License Application (MD5): Once testing and audit are complete.
8. For Imports, Compile Necessary Certifications: And apply for MD15 license.

Starting early and partnering with experienced consultants can save months and ensure your reusable rectoscope reaches the Indian market compliantly and efficiently.

For personalized guidance and to streamline your CDSCO licensing journey, connect with our regulatory experts today.