CDSCO License for Intravascular blood gas/pH monitoring system
Medical Device Information
Intended Use
An assembly of devices used for the continuous in vivo measurement and display of the values of pH and/or the partial pressure of CO2 and/or O2 in arterial blood. The system is used for patients with respiratory failure or severe pulmonary hypertension after cardiac surgery.
Comprehensive Guide to CDSCO Licensing for Intravascular Blood Gas/pH Monitoring System
As specialists with over 25 years of experience in medical device regulatory affairs, we understand the intricacies involved in obtaining the necessary CDSCO licenses to market medical devices like the Intravascular Blood Gas/pH Monitoring System in India. This device, classified as Class B under the Indian regulatory framework, plays a critical role in anesthesiology by enabling continuous in vivo monitoring of blood pH and gas levels for patients with respiratory failure or severe pulmonary hypertension post-cardiac surgery. Ensuring compliance with CDSCO regulations is paramount for manufacturers and importers to successfully enter and sustain their presence in the Indian market.
CDSCO Regulatory Framework for Intravascular Blood Gas/pH Monitoring Systems
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. The Intravascular Blood Gas/pH Monitoring System falls under the Class B category of medical devices, denoting moderate risk. According to the notification 29/Misc/03/2020-DC(177) dated 12.07.2021, manufacturers of Class B devices must obtain an MD5 license granted by the respective State Licensing Authority.
Risk Classification and License Requirements
| Device Type | Risk Class | License Type | Licensing Authority | Approximate Timeline | Government Fees |
|---|---|---|---|---|---|
| Intravascular Blood Gas/pH Monitoring Sys | B | MD5 | State Licensing Authority | 3-4 months | Rs 5,000 per application + Rs 500 per product |
Class B devices require adherence to the Essential Principles of Safety and Performance, compliance with the Quality Management System (QMS), and passing rigorous testing and audits.
Manufacturing License Process (MD5)
The MD5 license process for your Intravascular Blood Gas/pH Monitoring System involves several critical stages:
- Test License Application (Form MD13): Initially, you must apply for a Test License, allowing product testing in government-approved laboratories. This phase typically takes 1.5 to 2 months.
- Product Testing: The device must be tested at CDSCO-recognized testing labs to verify compliance with Indian standards. A list of approved testing laboratories can be accessed for selection.
- Document Preparation: Concurrently, gather and prepare all required documentation such as Device Master Files, Plant Master Files, and risk management reports.
- License Application (Form MD3): After successful testing, submit your application for the MD5 Manufacturing License through the CDSCO MD Online Portal.
- Audit by Notified Body: An audit by a notified body is mandatory to assess your QMS and manufacturing premises. Refer to the list of notified bodies for authorized auditors.
- Resolution of Queries: Address any queries or observations raised by the licensing authority or auditors promptly.
- Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license (Form MD5), authorizing manufacturing.
For a detailed walkthrough, our MD5 License Guide offers comprehensive insights.
Manufacturing License Documents Required
To ensure a smooth application process, compile the following documentation:
- Company constitution documents (e.g., incorporation certificate, partnership deed)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed design, specifications, and manufacturing process documentation (Device Master File Guide)
- Plant Master File (PMF): Details of manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist, demonstrating compliance with safety and performance standards
- Risk Management File, including hazard analysis and mitigation strategies (Risk Management)
- Product Test Reports from CDSCO-approved laboratories
- Device labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certified
Import License Process (MD15)
If you are an importer of the Intravascular Blood Gas/pH Monitoring System, you must obtain an Import License (MD15) from the Central Licensing Authority. The process generally takes 5 to 6 months and involves:
- Preparation of all required documentation including manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files.
- Submission of application (Form MD14) via the CDSCO MD Online Portal.
- Addressing any queries raised by the authority.
- Receipt of the import license (Form MD15).
For more 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 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license (if applicable)
- Company constitution and address proof
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 4 weeks |
| Document Preparation | Concurrent |
| MD5 License Application & Audit | 6 - 8 weeks |
| Query Resolution & License Grant | 2 - 4 weeks |
Total Estimated Time: 3 to 4 months
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 License | Rs 5,000 | Rs 500 |
Additional costs include:
- Testing laboratory fees (varies by lab and test complexity)
- Notified body audit charges (usually Rs 50,000 to Rs 1,00,000 depending on scope)
- Consultancy fees (if availing expert support)
Common Challenges and Solutions
Challenge: Delays in product testing due to lab backlogs.
Solution: Engage with multiple CDSCO-approved testing laboratories early to schedule your tests promptly.
Challenge: Incomplete or inconsistent documentation leading to queries.
Solution: Use checklists and templates available in our Device Master File and Plant Master File guides to ensure accuracy and completeness.
Challenge: Audit non-conformities.
Solution: Conduct pre-audit internal assessments and invest in robust QMS implementation following ISO 13485 standards.
Expert Consultation and Support
Having successfully guided over 500 companies through the CDSCO licensing maze, we provide tailored consultancy services including:
- Pre-submission gap analysis
- Device classification and regulatory strategy
- Preparation of Device and Plant Master Files
- Coordination with testing labs and notified bodies
- Application filing and follow-up
- Training on regulatory compliance and QMS
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm that your Intravascular Blood Gas/pH Monitoring System is Class B using the Medical Device Classification tool.
- Plan Testing Schedule: Contact CDSCO-approved labs early to book testing slots.
- Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our guides.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal and prepare for product testing.
- Engage Notified Body: Identify and appoint a notified body from the CDSCO list for your audit.
- File Manufacturing License Application: After test completion, submit Form MD3 for the MD5 license.
- Prepare for Audit: Ensure your QMS and facility are audit-ready.
Our team is ready to assist you at every step to ensure a smooth and successful licensing process. Reach out to us to leverage our deep expertise and streamline your journey to market entry in India.
