CDSCO License for Rigid sigmoidoscope
Medical Device Information
Intended Use
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum).
Comprehensive Guide to CDSCO Licensing for Rigid Sigmoidoscopes (Class B Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 companies, we understand the critical importance of obtaining the right CDSCO license to market medical devices like the Rigid Sigmoidoscope in India. This device, classified under risk class B, is essential for gastroenterological diagnostics and treatment, specifically designed for the visual examination and intervention in the sigmoid colon.
Understanding the Regulatory Framework for Rigid Sigmoidoscopes in India
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. The Rigid Sigmoidoscope falls under Category: Gastroenterology and is notified under the notification number 29/Misc./03/2020-DC (182) dated 27.09.2021.
Given its classification as a Class B device, the CDSCO mandates an MD5 manufacturing license for companies producing this device domestically. For importers, the MD15 import license applies.
Risk Classification and License Requirements for Rigid Sigmoidoscopes
Rigid Sigmoidoscopes are classified as Class B devices due to their invasive nature and moderate risk profile. According to CDSCO guidelines:
- Manufacturing License: MD5 License (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Typical Processing Time: 3-4 months (including test license, testing, and audit)
- Government Fees: Rs 5,000 per application + Rs 500 per product
For detailed classification criteria, refer to our Medical Device Classification guide.
Step-by-Step Manufacturing License Process for MD5 License
- Obtain Test License (Form MD13): Before applying for the manufacturing license, manufacturers need a test license which typically takes 1.5 to 2 months to be granted.
- Product Testing: Conduct product testing at CDSCO approved labs. You can check the list of Testing Laboratories authorized by CDSCO.
- Document Preparation: Prepare all mandatory documents including Device Master File and Plant Master File.
- Apply for MD5 License (Form MD3): Submit your application on the CDSCO MD Online Portal.
- Audit by Notified Body: The notified body will conduct an audit of your manufacturing facility. Refer to the list of notified bodies.
- Resolve Queries: Address any queries raised by the notified body or CDSCO.
- License Grant: Upon successful compliance, the MD5 license will be issued.
For a detailed walkthrough, our MD5 License Guide provides extensive insights.
Essential Documents Required for MD5 License Application
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification Certificates of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design and specifications. Learn how to prepare it with our Device Master File Guide.
- Plant Master File (PMF) describing the manufacturing setup. Refer to our Plant Master File Guide.
- Essential Principles Checklist ensuring compliance with safety and performance
- Risk Management File adhering to ISO 14971 standards. We recommend reviewing our Risk Management resource.
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, usually ISO 13485:2016 compliant
Import License Process for Rigid Sigmoidoscopes (MD15 License)
If you plan to import the Rigid Sigmoidoscope into India, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority and typically takes 5-6 months.
Key Steps:
- Prepare required documents including your manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
- Submit application via the CDSCO MD Online Portal.
- Address any departmental queries.
- Await grant of license on Form MD15.
Government fees:
- For Class B devices: Rs 2000 per site + Rs 1000 per product.
For detailed guidance, see our Import License Guide.
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 2 months (varies) |
| Manufacturing License (MD5) | 3 - 4 months total including above |
| Import License (MD15) | 5 - 6 months |
These timelines are realistic estimates but can vary depending on document completeness and audit scheduling.
Government Fees and Cost Breakdown
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | Rs 5,000 | Rs 500 |
| MD15 Import (Class B) | Rs 2,000 | Rs 1,000 |
Additional costs include product testing fees at government-approved labs and notified body audit fees.
Common Challenges and Practical Solutions
- Delayed Test License Approval: Early submission with complete documentation reduces delays.
- Incomplete Device Master File: Use our detailed guides to ensure comprehensive DMF and PMF preparation.
- Audit Non-compliance: Pre-audit internal checks and mock audits can significantly improve outcomes.
- Query Resolution Delays: Assign a dedicated regulatory liaison to promptly address CDSCO queries.
Expert Consultation and Support
Navigating the CDSCO licensing process for a specialized device like the Rigid Sigmoidoscope can be complex. Our team offers tailored consultancy services, from initial classification to final license grant, ensuring compliance with all regulatory requirements and minimizing your time to market.
Getting Started with Your CDSCO License Application
- Assess your device classification and confirm the applicable license type (MD5 for manufacture, MD15 for import).
- Compile and review all necessary documents with attention to detail, especially Device Master File and Plant Master File.
- Apply for the test license (MD13) promptly to kick-start product testing.
- Identify and engage with a notified body early for audit planning.
- Submit your application online via the CDSCO MD Online Portal.
- Prepare for audit and maintain open communication to swiftly resolve any queries.
Embarking on this journey with a knowledgeable partner can save you months of effort and ensure a smooth regulatory experience. Contact us today to leverage our extensive expertise in CDSCO licensing for Rigid Sigmoidoscopes and other Class B medical devices.
