CDSCO License for Flexible endoscopic stone- retrieval forceps, reusable
Medical Device Information
Intended Use
A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure.
Comprehensive Guide to CDSCO Licensing for Flexible Endoscopic Stone-Retrieval Forceps (Reusable)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized instruments like the flexible endoscopic stone-retrieval forceps, reusable. As a urology device classified under Risk Class B, this product demands adherence to specific regulatory requirements mandated by the Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience assisting 500+ companies, we provide precise, actionable guidance to streamline your journey towards obtaining the necessary CDSCO license.
Understanding Your Medical Device and Its Regulatory Importance
The flexible endoscopic stone-retrieval forceps is a precision manual instrument designed for insertion through the working channel of flexible endoscopes. Its primary function is to grasp and remove calculi or foreign bodies during endoscopic procedures within the urinary tract. Given the invasive nature and clinical application, CDSCO classifies it as a Class B medical device under the urology category, which carries moderate risk requiring careful regulatory oversight.
Obtaining CDSCO approval is not just a legal mandate but a critical step to ensure patient safety, product quality, and market acceptance in India. Compliance also facilitates smoother customs clearance and builds trust with healthcare providers.
CDSCO Regulatory Framework for Flexible Endoscopic Stone-Retrieval Forceps
India’s regulatory framework for medical devices has evolved significantly, with CDSCO as the central authority overseeing device registration, manufacturing, and import licensing. For Class B devices like yours, the manufacturing license is issued by the State Licensing Authority under the MD5 license scheme. The process integrates essential safety checks including product testing, technical documentation review, and a notified body audit.
You will primarily interact with the CDSCO MD Online Portal for all application submissions and tracking.
Risk Classification and License Requirements
Medical devices in India are classified into four risk classes: A, B, C, and D. Your flexible endoscopic stone-retrieval forceps falls under Class B (Low Moderate Risk) according to CDSCO’s classification rules.
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Issuing Authority: State Licensing Authority
- Typical Processing Time: 3 to 4 months (including test license and audit)
For a detailed understanding of device classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5 License)
The MD5 license process for Class B devices involves several key stages:
Test License Application (Form MD13): Before applying for the manufacturing license, you must obtain a test license which allows you to manufacture limited quantities for testing. This step takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing of your forceps at CDSCO-approved laboratories. You can find the list of approved labs on the CDSCO Testing Laboratories page.
Document Preparation: Compile the required technical and quality documentation.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Notified Body Audit: Engage with a notified body for a comprehensive audit of your manufacturing facility and quality system. Refer to the list of notified bodies authorized for MD5 audits.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon satisfactory review, the State Licensing Authority issues the manufacturing license.
Manufacturing License Documents Required
For your flexible endoscopic stone-retrieval forceps, ensure the following documents are prepared meticulously:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details & Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) covering design, materials, and performance
- Plant Master File (PMF) detailing manufacturing processes and control mechanisms
- Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
- Risk Management File illustrating hazard analysis and mitigation (See our Risk Management guide)
- Product Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485 certification helps but is not mandatory)
Our Device Master File guide and Plant Master File guide provide comprehensive templates and checklists to aid document preparation.
Import License Process (MD15 License)
If you plan to import the flexible endoscopic stone-retrieval forceps, the import license application is submitted to the Central Licensing Authority using Form MD14. The MD15 license process typically takes 5 to 6 months.
Key steps include:
- Document compilation (including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate if applicable, Device and Plant Master Files)
- Application submission via CDSCO MD Online Portal
- Query resolution
- License grant
Refer to our detailed Import License guide for more insights.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Typical Processing Time | Key Phases |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application, Testing Authorization |
| Manufacturing License (MD5) | 3 - 4 months | Testing, Document Review, Audit, Licensing |
| Import License (MD15) | 5 - 6 months | Documentation, Review, Licensing |
Government Fees and Costs
For your Class B device’s MD5 license:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs include notified body audit fees (varies by body), testing laboratory charges (depends on tests), and internal expenses for document preparation and quality system implementation.
Common Challenges and Solutions
Challenge: Delay in obtaining test reports from government labs.
Solution: Engage with approved private labs early, ensure sample compliance, and follow up diligently.
Challenge: Incomplete or inconsistent documentation leading to queries.
Solution: Utilize experienced consultants and refer to standardized guides for DMF, PMF, and risk management.
Challenge: Audit non-compliance.
Solution: Conduct internal pre-audit assessments and gap analysis before notified body visits.
Expert Consultation and Support
With our vast experience guiding over 500 medical device firms through the CDSCO maze, we provide end-to-end support including:
- Gap analysis and regulatory strategy
- Document drafting and review
- Liaison with notified bodies and CDSCO
- Training on QMS and compliance
Our tailored approach ensures your flexible endoscopic stone-retrieval forceps meet all Indian regulatory expectations efficiently.
Getting Started with Your CDSCO License Application
- Initiate a thorough product risk assessment and classification confirmation.
- Prepare your technical documentation, Device Master File, and Plant Master File using our expert guides.
- Apply for the test license (Form MD13) on the CDSCO MD Online Portal.
- Simultaneously identify a notified body and testing laboratory to schedule audits and product testing.
- Maintain open communications with CDSCO and be prompt in responding to any queries.
Starting early and maintaining a proactive approach significantly reduces approval timelines and avoids common pitfalls. Contact us for a personalized consultation to expedite your CDSCO licensing journey for your flexible endoscopic stone-retrieval forceps.
Harness our 25+ years of regulatory expertise to confidently launch your urology device in India. Secure your MD5 license with precision and compliance for sustained market success.
