CDSCO License for Airway pressure alarm
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 device connected to the breathing circuit that monitors a patient upper airway pressure during assisted mechanical ventilation.
Comprehensive Guide to CDSCO Licensing for Airway Pressure Alarm (Class A Medical Device)
As specialists with over 25 years of experience in medical device regulatory consultancy, having successfully assisted more than 500 companies in India, we understand the nuances of obtaining CDSCO licenses. The airway pressure alarm, a Class A device under anesthesiology, is critical in monitoring a patient’s upper airway pressure during assisted mechanical ventilation. Navigating the regulatory framework for this device requires precise knowledge, detailed documentation, and adherence to timelines.
CDSCO Regulatory Framework for Airway Pressure Alarm
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Since the notification [29/Misc/03/2020-DC(177)] dated 12.07.2021, the airway pressure alarm falls under Class A (low risk), requiring an MD5 manufacturing license granted by the State Licensing Authority.
This regulatory pathway ensures that devices meet safety, efficacy, and quality standards before entering the Indian market. Our role is to help you streamline this process with a clear understanding of requirements and practical guidance.
Risk Classification and License Requirements
- Device: Airway Pressure Alarm
- Risk Class: A (Low Risk)
- Applicable License: MD5 License (Form MD3)
- Licensing Authority: State Licensing Authority
Class A devices like airway pressure alarms require less stringent but thorough compliance checks, including obtaining a test license (Form MD13) before full license approval.
Manufacturing License Process (MD5)
The manufacturing license for a Class A device is a multi-step process typically spanning 3 to 4 months:
Apply for Test License (Form MD13): This preliminary license allows you to test the device in government-approved labs. Processing takes approximately 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-recognized laboratories to generate valid test reports. Refer to the list of testing laboratories for approved facilities.
Documentation Preparation: Compile all required documents, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Submission of Application (Form MD3): Submit your MD5 license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body ensures compliance with manufacturing practices. Check the list of notified bodies to select an appropriate auditor.
Resolution of Queries: Address any queries raised by the licensing authority or notified body promptly.
Grant of Manufacturing License (Form MD5): Upon successful review and audit, the license will be granted.
Manufacturing License Documents Required
For the airway pressure alarm, the following documents are essential:
- Company Constitution (Incorporation Certificate, MOA & AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualifications and Experience Certificates
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – detailing design, specifications, and manufacturing processes. Our Device Master File guide offers step-by-step assistance.
- Plant Master File (PMF) – outlining facility standards and equipment. Learn more from our Plant Master File guide.
- Essential Principles Checklist
- Risk Management File documenting hazard analysis and mitigations, aligned with ISO 14971. Refer to our Risk Management insights.
- Test Reports from CDSCO-recognized laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents such as ISO 13485 certification
Import License Process (MD15)
If you are an importer of airway pressure alarms, an MD15 import license is mandatory. This license is granted by the Central Licensing Authority and generally takes 5 to 6 months.
The process involves:
- Preparation of key documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, and wholesale license.
- Submission of the application on the CDSCO MD Online Portal.
- Responding to departmental queries.
- Final grant of license (Form MD15).
Import License Documents Required
- Valid Manufacturing License of the device from the country of origin
- Free Sale Certificate issued by regulatory authority of the exporting country
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (Form MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| MD5 License Application & Audit | 1 – 1.5 months |
| Total Time for MD5 License | 3 – 4 months |
For import licenses (MD15), the end-to-end process typically takes 5 to 6 months.
Government Fees and Costs
For the airway pressure alarm (Class A device):
MD5 License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
Test License (Form MD13): Fees vary; consult respective state authority
Import License (MD15):
- Site Fee: $1000
- Per Product Fee: $50
Budgeting for notified body audits and testing laboratory fees is also essential and can vary depending on the scope.
Common Challenges and Solutions
- Delayed Test Reports: Ensure early booking with CDSCO-recognized testing labs to avoid bottlenecks.
- Incomplete Documentation: Utilize comprehensive checklists and experienced consultants to prepare flawless submissions.
- Audit Non-Compliance: Engage with notified bodies early to understand audit expectations and conduct internal pre-audits.
- Query Resolution Delays: Assign dedicated personnel for prompt and clear communication with CDSCO.
Expert Consultation and Support
With over two decades of experience and over 500 successful license procurements, we offer end-to-end consulting services including documentation, audit support, and liaison with CDSCO officials. Our expertise in anesthesiology devices like airway pressure alarms ensures you avoid pitfalls and accelerate market entry.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm that your airway pressure alarm is Class A and requires an MD5 license.
- Prepare Documentation: Begin compiling the Device Master File and Plant Master File early.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
- Schedule Product Testing: Contact CDSCO-approved testing laboratories to plan timely testing.
- Engage a Notified Body: Select a notified body for audit from the official list.
- Submit MD5 Application: Once test reports and documentation are ready, submit Form MD3 for the manufacturing license.
- Prepare for Audit and Queries: Be ready to provide clarifications and implement corrective actions as needed.
Embarking on the CDSCO licensing journey with a structured approach and expert support can dramatically reduce time-to-market and regulatory risks. Contact us today to leverage our proven track record in securing MD5 licenses for airway pressure alarms and other Class A devices.
