CDSCO License for Mechanical positive pressure airway secretion- clearing device
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 hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease.
Comprehensive Guide to CDSCO Licensing for Mechanical Positive Pressure Airway Secretion-Clearing Device (Class A)
As specialists with over 25 years of experience in Indian medical device regulatory compliance, we understand the complexities manufacturers and importers face in obtaining CDSCO licenses. The mechanical positive pressure airway secretion-clearing device, classified under Risk Class A and categorized in anesthesiology, requires precise adherence to regulatory frameworks to enter the Indian market smoothly. This guide provides detailed, practical insights into the CDSCO licensing process tailored specifically for this device.
Understanding the Device and Its Regulatory Importance
The mechanical positive pressure airway secretion-clearing device is a hand-held apparatus designed to assist patients suffering from acute or chronic lung diseases by mechanically removing mucus or sputum from the lungs and upper airways. Given its direct impact on respiratory health, ensuring regulatory compliance is paramount to guarantee safety, efficacy, and quality.
India’s Central Drugs Standard Control Organization (CDSCO) mandates that all such medical devices obtain the requisite manufacturing or import licenses before marketing or distribution.
CDSCO Regulatory Framework for Mechanical Positive Pressure Airway Secretion-Clearing Devices
According to the CDSCO notification 29/Misc/03/2020-DC(177) dated 12.07.2021, this device falls under Risk Class A — the lowest risk category. Devices in this class require obtaining an MD5 manufacturing license from the State Licensing Authority.
The regulatory framework involves:
- Classification of the device per Indian Medical Device Rules (MDR) 2017
- Compliance with Essential Principles of Safety and Performance
- Obtaining a Test License (Form MD13) before full manufacturing license
- Product testing at government-approved laboratories
- On-site audit by a notified body
- Submission through the CDSCO MD Online Portal
Risk Classification and License Requirements
Risk Class: A
License Type: MD5 Manufacturing License (Form MD3)
Issuing Authority: State Licensing Authority
Total Processing Time: Approximately 3-4 months
Fees: Rs 5,000 per application + Rs 500 per product
Given the Class A risk categorization, the MD5 license is streamlined but still stringent in documentation and testing.
Step-by-Step Manufacturing License Process (MD5)
Apply for Test License (Form MD13): This mandatory step allows you to manufacture a sample batch for testing. The test license typically takes 1.5 to 2 months to process.
Product Testing: Submit your device samples to CDSCO-approved testing laboratories (see the Testing Laboratories list). Testing covers biocompatibility, mechanical safety, and performance standards.
Documentation Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Submit Manufacturing License Application (Form MD3): File this application through the CDSCO MD Online Portal with complete documents and testing reports.
Audit by Notified Body: An audit will be conducted by a notified body listed here to verify manufacturing facilities, QMS, and compliance.
Resolution of Queries: Respond promptly to any queries raised during the audit or by CDSCO officials to avoid delays.
Grant of MD5 License (Form MD5): Upon satisfactory review, the State Licensing Authority will issue the manufacturing license.
Manufacturing License Documents Required
For the mechanical positive pressure airway secretion-clearing device, you need to prepare the following detailed documentation:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed device description, drawings, specifications, and manufacturing process (Learn more about DMF)
- Plant Master File (PMF): Layout, equipment details, and environmental controls (PMF Guide)
- Essential Principles Checklist: Compliance with safety and performance standards
- Risk Management File: Hazard analysis and risk mitigation per ISO 14971 (Risk Management Guide)
- Product Test Reports from Government-Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: Typically ISO 13485 compliant
Import License Process (MD15) for Mechanical Airway Devices
If you plan to import this device into India, you must apply for an MD15 Import License from the Central Licensing Authority.
Key Points:
- Processing time: 5-6 months
- No test license required
- Requires submission of Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, and other regulatory documents
- Fees vary by risk class and number of products
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| Process Step | Estimated Timeframe |
|---|---|
| Test License (Form MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | Concurrent with testing |
| Submission & Initial Review | 1 - 2 weeks |
| Audit by Notified Body | 2 - 3 weeks |
| Query Resolution | 2 - 4 weeks |
| License Granting | 1 week |
Total: Approximately 3-4 months from application start to license grant.
Government Fees and Costs Breakdown
- Test License (MD13): Rs 2,500 (approx.)
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Testing Charges: Vary by laboratory and tests but budget Rs 50,000 to Rs 1,00,000
- Audit Fees: Usually borne by applicant, ranges around Rs 20,000 to Rs 40,000 depending on notified body
Common Challenges and Solutions
- Incomplete Documentation: Meticulous checklist preparation avoids rejections.
- Delayed Testing: Engage with notified testing labs early to schedule tests.
- Audit Non-Compliance: Pre-audit internal checks and training help smooth inspections.
- Query Delays: Assign dedicated regulatory personnel for prompt responses.
- Understanding Regulations: Regularly consult updated notifications and guidelines.
Expert Consultation and Support
With experience assisting over 500 companies, we provide end-to-end support from classification, dossier preparation, test license procurement, audit facilitation, to final license grant. Our regulatory experts keep abreast of evolving CDSCO requirements ensuring minimal delays and cost-effective compliance.
Getting Started with Your CDSCO License Application
Classify your device correctly: Confirm Class A status using the Medical Device Classification resource.
Enroll on the CDSCO MD Online Portal: Create an account and familiarize yourself with the submission process at CDSCO MD Online Portal.
Prepare your test license application (Form MD13): Gather initial documents and submit your application.
Coordinate product testing: Contact approved laboratories early to plan timelines.
Compile your dossier: Use expert templates for Device Master File and Plant Master File to ensure compliance.
Identify and engage a notified body: Select from the notified bodies list for your audit.
Plan resources: Allocate budget and schedule for fees, testing, audit, and documentation.
By following these actionable steps, manufacturers and importers can confidently navigate the CDSCO licensing process for mechanical positive pressure airway secretion-clearing devices and successfully enter the Indian medical device market.
