CDSCO License for Respiratory apnoea monitoring system
Medical Device Information
Intended Use
An assembly of devices designed to detect the cessation of breathing (apnoea) in patient who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s).
Comprehensive Guide to CDSCO Licensing for Respiratory Apnoea Monitoring Systems (Class B)
Introduction: Understanding Respiratory Apnoea Monitoring Systems and Regulatory Importance
Respiratory apnoea monitoring systems are critical medical devices designed to detect cessation of breathing episodes in patients at risk of respiratory failure. These systems alert caregivers or attendants to life-threatening apnoea events, enabling timely intervention. Given their vital role in patient safety, regulatory compliance by the Central Drugs Standard Control Organisation (CDSCO) in India is mandatory for manufacturers and importers aiming to market these devices.
As an expert regulatory consultancy with over 25 years of experience assisting 500+ companies, we provide comprehensive insights on obtaining CDSCO licenses for Class B devices like your respiratory apnoea monitoring system, categorized under respiratory devices (Notification File No. 29/Misc/03/2020-DC(197), dated 6.8.2021).
CDSCO Regulatory Framework for Respiratory Apnoea Monitoring Systems
Under the Medical Device Rules (MDR) 2017, respiratory apnoea monitoring systems fall under Class B – low moderate risk devices. CDSCO oversees the licensing, quality, and safety requirements through a structured regulatory pathway involving state licensing authorities for manufacturing and central licensing authorities for import.
Compliance ensures not only legal marketing authorization but also builds trust with healthcare providers and end users regarding device safety and efficacy.
Risk Classification and License Requirements
- Risk Class: B (Low Moderate Risk)
- License Type: MD5 (Manufacturing License)
- Governing Authority: State Licensing Authority
- Application Form: MD3 for manufacturing license
Class B devices require a manufacturing license granted by the state authority, involving testing, audit by notified bodies, and comprehensive documentation.
Manufacturing License Process (MD5) for Respiratory Apnoea Monitoring Systems
The MD5 license process unfolds in multiple phases:
Test License Application (Form MD13):
- Apply for a test license to manufacture sample products for testing.
- Duration: Approximately 1.5-2 months.
Product Testing:
- Conduct mandatory testing at CDSCO-approved government laboratories.
- Testing ensures compliance with Essential Principles and safety standards.
- Find certified Testing Laboratories.
Document Preparation:
- Compile and review all technical documents, including Device and Plant Master Files.
License Application (Form MD3):
- Submit the MD5 license application through the CDSCO MD Online Portal.
Audit by Notified Body:
- Undergo facility and quality system audit by a CDSCO-recognized notified body.
- Refer to the Notified Bodies List for selection.
Query Resolution:
- Respond promptly to any queries from CDSCO or notified bodies.
Grant of License (Form MD5):
- After satisfactory review and audit, the state authority grants the manufacturing license.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership or rental agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes. For guidance, see our Device Master File guide.
- Plant Master File describing manufacturing environment and quality systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File aligned with ISO 14971 principles (see Risk Management insights)
- Test Reports from approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Respiratory Apnoea Monitoring Systems
For importers, the MD15 license is mandatory before marketing the respiratory apnoea monitoring system in India. The process involves:
- Document preparation (including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate if applicable)
- ISO 13485:2016 certification
- Device and Plant Master Files
- Wholesale License
- Submission of application through the CDSCO MD Online Portal
- Query resolution
- Grant of Import License on Form MD15
Typically, the import license process takes 5-6 months.
For comprehensive details, refer to our Import License guide.
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
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 4 to 6 weeks |
| Document Preparation | 2 to 4 weeks |
| MD5 License Application | 1 to 2 weeks |
| Audit by Notified Body | Scheduled within 1 month |
| Query Resolution | 2 to 4 weeks |
| Grant of License | After satisfactory review |
Total Estimated Time: Approximately 3-4 months from test license application to grant of manufacturing license.
Government Fees and Costs
- Test License (MD13): Generally included within application fees
- MD5 Manufacturing License Fees:
- Rs. 5,000 per application
- Rs. 500 per product
Additional costs include testing fees at government-approved labs and notified body audit charges (varies depending on notified body).
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or poorly prepared Device/Plant Master Files often delay approvals. Ensure thorough preparation using templates and guidance from experts.
Test Report Delays: Testing at government labs can sometimes experience backlogs. Pre-book testing slots and consider parallel document preparation.
Audit Non-compliance: Non-adherence to QMS or premises standards can result in audit failures. Conduct internal audits and pre-assessment before notified body visits.
Query Management: Delayed or vague responses prolong processing. Assign a dedicated regulatory expert to handle queries promptly and comprehensively.
Expert Consultation and Support
With over 25 years of experience and having supported over 500 manufacturers and importers, we provide end-to-end support including:
- Preparation of Device and Plant Master Files
- Application filing on the CDSCO MD Online Portal
- Coordination with notified bodies and testing labs
- Audit preparation and mock inspections
- Query handling and liaison with CDSCO officials
Our practical insights help mitigate risks, reduce timelines, and ensure successful licensing for respiratory apnoea monitoring systems.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm the device as Class B using the Medical Device Classification tool.
Prepare Technical Documentation: Begin compiling your Device Master File and Plant Master File, aligning with regulatory requirements.
Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
Plan Testing and Audit: Schedule product testing at an approved lab and select a notified body for subsequent audit.
Engage Expert Support: Consider consulting experienced regulatory professionals to streamline your application process.
By following these actionable steps and leveraging expert guidance, your respiratory apnoea monitoring system can secure timely CDSCO licensing, enabling you to enter the Indian market confidently and compliantly.
