CDSCO License for Nasopharyngeal Catheter/Nasopharyngeal
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A catheter (for adults) passed through the nares and advanced to the depth of the nasopharynx to remove air choke or obstruction. AResuscitator.
Comprehensive Guide to CDSCO Licensing for Nasopharyngeal Catheters (Class A Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for critical devices like the Nasopharyngeal Catheter. Designed for adults to be inserted through the nares and advanced to the nasopharynx to relieve airway obstruction, this device falls under the Class A risk category. Given its crucial role in airway management and resuscitation, securing the appropriate CDSCO license is not just a legal requirement but a vital step to ensure safety and compliance.
With over 25 years of experience helping 500+ companies successfully obtain CDSCO licenses, we provide you with a detailed, actionable roadmap specifically tailored for Nasopharyngeal Catheters under the latest CDSCO regulations.
CDSCO Regulatory Framework for Nasopharyngeal Catheters
Nasopharyngeal catheters are categorized under medical devices notified by CDSCO under Notification No. 29/Misc/3/2017-DC (292), dated 06.06.2018. As a Class A device, it is considered low risk, but regulatory compliance remains mandatory.
The regulatory framework is governed by the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). Manufacturers or importers of this device must comply with these rules to legally market the product in India.
For Class A devices like the Nasopharyngeal Catheter, the MD5 license issued by the State Licensing Authority is essential for manufacturing. This license ensures adherence to quality, safety, and performance standards.
To apply, submit your documentation through the official CDSCO MD Online Portal.
Risk Classification and License Requirements for Nasopharyngeal Catheter
- Risk Class: A (Low Risk)
- License Type: MD5 License (Manufacturing)
- Application Form: MD3
- Issuing Authority: State Licensing Authority
- Processing Time: Approximately 3-4 months (including test license and audit)
Class A devices carry minimal risk but require a rigorous process involving product testing, documentation, and audit to ensure compliance.
Manufacturing License Process for Nasopharyngeal Catheters (MD5)
The MD5 license process is a multi-step journey:
Test License (Form MD13): Before applying for an MD5 license, manufacturers must secure a test license valid for 1.5 to 2 months. This permits manufacturing of limited quantities for testing purposes.
Product Testing: Samples of the Nasopharyngeal Catheter must be tested by CDSCO-approved laboratories to verify safety and performance. Refer to the Testing Laboratories List for authorized labs.
Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission: Submit Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: The manufacturing site undergoes an audit by a notified body accredited by CDSCO. For audit requirements, consult the Notified Bodies List.
Queries and Clarifications: Respond promptly to any queries from CDSCO or the notified body.
Grant of MD5 License: Upon successful audit and review, the license is issued on Form MD5.
We recommend initiating the test license application immediately upon readiness to avoid unnecessary delays.
Manufacturing License Documents Required for Nasopharyngeal Catheters
To ensure a smooth application process, gather the following key documents:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire No-Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing information. Our Device Master File guide provides expert insights.
- Plant Master File (PMF): Facility details and quality systems. Learn more in our Plant Master File guide.
- Essential Principles Checklist aligning with MDR 2017
- Risk Management File detailing hazard identification and mitigation strategies
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (typically ISO 13485 compliant)
Ensure all documents are comprehensive and compliant to avoid audit complications.
Import License Process (MD15) - Not Applicable for Manufacturing but Relevant for Importers
If you are an importer of Nasopharyngeal Catheters, an MD15 license granted by the Central Licensing Authority is mandatory. The process involves:
- Preparation of documents including Manufacturing License, Free Sale Certificate, ISO 13485, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.
- Submission of Form MD14 via the CDSCO MD Online Portal.
- Resolution of departmental queries.
- Grant of MD15 license.
The entire import license process typically spans 5-6 months.
Import License Documents Required
- Valid Manufacturing License for the device
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
The detailed Import License guide offers valuable insights.
Timeline and Processing Duration for Nasopharyngeal Catheter Licensing
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Documentation Prep | 3 - 4 weeks |
| Application Submission | Immediate post-doc |
| Audit and Review | 4 - 6 weeks |
| Queries Resolution | 2 - 4 weeks |
| Total Time | 3 - 4 months |
Planning ahead and initiating each step promptly can prevent delays.
Government Fees and Costs
For the MD5 license for Class A devices:
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
Additional costs to consider:
- Testing fees charged by government-approved labs
- Fees for notified body audit
- Preparation costs for documentation and QMS implementation
Budgeting for these expenses early will streamline your project.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Schedule testing early and choose CDSCO-approved labs with proven turnaround times. Our Testing Laboratories List can help you select credible labs.
Challenge 2: Insufficient Documentation Quality
- Solution: Engage experienced consultants for Device Master File and Plant Master File preparation. Detailed guides are available in our DMF and PMF resources.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal audits and gap assessments before the notified body visit. Ensure QMS and facilities meet CDSCO requirements.
Challenge 4: Query Resolution Delays
- Solution: Maintain clear communication channels and respond to CDSCO or notified body queries comprehensively and swiftly.
Expert Consultation and Support
Our team has guided over 500 companies through the intricacies of obtaining MD5 licenses for Class A devices like Nasopharyngeal Catheters. We offer:
- End-to-end application management
- Documentation preparation and review
- Pre-audit assessments
- Liaison with CDSCO and notified bodies
Partnering with experienced consultants can significantly reduce processing times and enhance compliance.
Getting Started with Your CDSCO License Application for Nasopharyngeal Catheter
Evaluate Your Product Classification: Confirm the device as Class A using the Medical Device Classification guide.
Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
Engage Accredited Testing Laboratories: Send product samples for testing promptly.
Prepare Comprehensive Documentation: Utilize expert resources and templates for DMF, PMF, Risk Management, and QMS.
Schedule Notified Body Audit: Coordinate with CDSCO-approved notified bodies early.
Submit Final Application (Form MD3): Once test license and testing are complete, apply for the MD5 manufacturing license.
Respond to Queries Promptly: Maintain readiness for any clarifications requested.
Taking these practical steps methodically will position your Nasopharyngeal Catheter for successful market entry in India.
For personalized support, feel free to reach out to our regulatory experts who specialize in CDSCO licensing.
Empower your medical device business with trusted regulatory compliance. Our proven expertise ensures your Nasopharyngeal Catheter meets all Indian regulatory standards efficiently and effectively.
