CDSCO License for Flexible ultrasound gastroduodenos cope
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy.
Comprehensive Guide to CDSCO Licensing for Flexible Ultrasound Gastroduodenoscope (Class B)
As a company with over 25 years of experience assisting more than 500 medical device manufacturers and importers, we understand the critical importance of securing timely and compliant CDSCO licenses for sophisticated devices. The Flexible Ultrasound Gastroduodenoscope, classified as a Class B medical device under CDSCO regulations, is a vital tool in interventional radiology and gastroenterology. This device combines endoscopic and ultrasound capabilities to enable detailed visual examination and therapeutic interventions in the upper gastrointestinal tract.
Navigating the regulatory framework set forth by the Central Drugs Standard Control Organization (CDSCO) can be complex. Our expert insights will walk you through the entire process, from classification and documentation to audit and final license issuance.
CDSCO Regulatory Framework for Flexible Ultrasound Gastroduodenoscope
The CDSCO categorizes medical devices based on risk classes A to D. The Flexible Ultrasound Gastroduodenoscope is a Class B device, which implicates moderate risk requiring a Manufacturing License (MD5) issued by the respective State Licensing Authority.
Being an interventional radiology device intended for intricate clinical use, it must comply with the Medical Device Rules, 2017, and the specific notification 29/Misc./03/2020-DC (146) dated 26.07.2021.
Risk Classification and License Requirements
- Risk Class: B (Moderate risk)
- License Type: MD5 (Manufacturing License for Class A and B devices)
- Governing Authority: State Licensing Authority
- Application Form: MD3
This classification requires manufacturers to follow a stringent evaluation pathway including a test license, product testing, audit by notified bodies, and document submission.
Manufacturing License Process (MD5) for Class B Devices
The licensing process for Class B devices like the Flexible Ultrasound Gastroduodenoscope involves several sequential steps:
Test License (Form MD13): Before manufacturing, obtain a test license to produce limited units for testing and validation. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Testing covers safety, performance, and compliance with essential principles. Refer to the list of government-approved testing laboratories.
Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit by a notified body is conducted to verify compliance. You can check the list of notified bodies authorized for MD5 audits.
Queries and Clarifications: Address any queries raised by CDSCO or the notified body promptly to avoid delays.
Grant of License (Form MD5): Upon satisfactory completion of audit and document review, the manufacturing license is granted.
Manufacturing License Documents Required for Flexible Ultrasound Gastroduodenoscope
The application package must include:
- Company Constitution Documents: Incorporation certificate, memorandum of association, and articles of association.
- Proof of Premises Ownership or Lease Deed: Valid documentation proving rights to the manufacturing site.
- Technical Staff Details: Qualification and experience certificates of technical personnel involved in manufacturing.
- No Objection Certificates: Fire safety clearance and pollution control board clearance.
- Device Master File (DMF): Detailed product specifications, design, and manufacturing process. Our Device Master File guide offers comprehensive assistance.
- Plant Master File (PMF): Information on the manufacturing facility, equipment, and quality systems. For detailed guidance, see our Plant Master File guide.
- Essential Principles Checklist: Declaration of conformity to safety and performance standards.
- Risk Management File: Documentation of risk assessment and mitigation strategies as per ISO 14971. Learn more about risk management.
- Test Reports: Certificates from CDSCO-approved testing laboratories.
- Labels and Instructions for Use (IFU): Final product labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and quality manuals.
Import License Process (MD15) for Flexible Ultrasound Gastroduodenoscope
For importers, obtaining an MD15 Import License from the Central Licensing Authority is mandatory before marketing the device in India. The process steps include:
Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and Wholesale License.
Application Submission: File application using Form MD14 via the CDSCO MD Online Portal.
Queries Resolution: Respond to any clarifications requested by CDSCO.
License Grant: After due diligence, CDSCO issues the import license (Form MD15).
The entire import license process takes approximately 5 to 6 months.
Import License Documents Required
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Marking Certificate
- Device Master File
- Plant Master File
- Wholesale License for import
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Document Preparation | 3 - 4 weeks |
| MD5 License Application | 3 - 4 months total |
| Import License (MD15) | 5 - 6 months total |
The manufacturing license process for Class B devices typically spans 3 to 4 months after obtaining the test license.
Government Fees and Costs
MD5 Manufacturing License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD13 Test License:
- Included in the manufacturing license process, no separate fee specified.
MD15 Import License Fees:
- Site Fee for Class B: $2,000 per site
- Product Fee: $1,000 per product
Budgeting for testing and audit fees payable to notified bodies and laboratories is essential. These vary but typically range from Rs. 50,000 to Rs. 1,00,000 depending on scope.
Common Challenges and Solutions
Delayed Documentation Preparation: Start early and leverage expert consultants to prepare flawless Device and Plant Master Files to avoid back-and-forth with CDSCO.
Audit Non-Conformities: Conduct pre-audit internal assessments to ensure compliance with QMS and regulatory standards.
Testing Delays: Schedule testing with CDSCO-approved laboratories in advance and confirm their capacity.
Query Resolution: Maintain proactive communication with CDSCO and respond promptly to queries to avoid timeline extensions.
Technical Staff Qualification Issues: Ensure your technical team meets CDSCO’s minimum qualification criteria and maintain updated documentation.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we provide tailored support including:
- Regulatory strategy and classification confirmation
- Complete documentation preparation and review
- Coordination with notified bodies and testing labs
- Application filing and follow-up on the CDSCO MD Online Portal
- Audit readiness and gap analysis
Our deep domain knowledge ensures your Flexible Ultrasound Gastroduodenoscope reaches the Indian market with minimal regulatory hurdles.
Getting Started with Your CDSCO License Application
Verify Device Classification: Confirm your device falls under Class B as per CDSCO guidelines using the Medical Device Classification tool.
Gather Core Documents: Start collecting your Device Master File, Plant Master File, and essential QMS certifications.
Apply for Test License (MD13): Submit your initial application through the CDSCO MD Online Portal to begin manufacturing test units.
Schedule Product Testing: Coordinate with CDSCO-approved testing laboratories early to avoid bottlenecks.
Prepare for Audit: Engage with a notified body from the official list of notified bodies to arrange your mandatory audit.
Submit Manufacturing License Application (MD5): Once testing and audit are complete, file Form MD3 with all supporting documents.
Monitor and Respond: Proactively manage queries from CDSCO to ensure smooth approval.
We recommend leveraging expert regulatory consultants to streamline this multifaceted process, reduce errors, and accelerate market entry.
For personalized assistance with your Flexible Ultrasound Gastroduodenoscope CDSCO licensing, feel free to contact us. Our seasoned team is committed to helping you achieve regulatory compliance efficiently and successfully.
