CDSCO License for Bulk oxygen concentration system
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
An assembly of devices designed to concentrate medical grade oxygen (O2) from ambient air and then deliver the concentrated O2, with purity of up to 93%- 99.5%, to the hospital medical gas supply system for therapeutic use on patients in Hospital.
Comprehensive CDSCO Licensing Guide for Bulk Oxygen Concentration System (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and successful support for 500+ medical device companies, we understand the critical importance of securing timely and compliant CDSCO licenses for medical devices. The Bulk Oxygen Concentration System is a Class A respiratory medical device designed to concentrate medical-grade oxygen from ambient air for therapeutic use in hospitals. Given its vital role in hospital medical gas supply systems, adherence to the Central Drugs Standard Control Organisation (CDSCO) regulatory framework is mandatory for manufacturing and marketing this device in India.
CDSCO Regulatory Framework for Bulk Oxygen Concentration Systems
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, categorizing devices based on risk levels. Bulk oxygen concentrators fall under Class A (low risk) according to the notification File No. 29/Misc/03/2020-DC(197) dated 6.8.2021. Compliance with State Licensing Authority requirements and obtaining an MD5 manufacturing license is mandatory for domestic manufacturers.
Risk Classification and License Requirements for Bulk Oxygen Concentrators
- Risk Class: A (Low Risk)
- Regulatory License: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Applicable Rules: Medical Device Rules, 2017 (MDR 2017)
This classification means the licensing process is state-level but involves comprehensive documentation, testing, and audit.
Manufacturing License Process (MD5) for Bulk Oxygen Concentration System
The MD5 license application comprises multiple sequential steps:
- Test License (Form MD13): Obtain a test license allowing product testing by government-approved labs. This step typically takes 1.5 to 2 months.
- Product Testing: Submit the device for testing at notified laboratories to verify conformity with applicable standards.
- Document Preparation: Compile technical documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
- License Application (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an on-site audit by a CDSCO-approved notified body. You can check the list of notified bodies to select the appropriate auditor.
- Queries Resolution: Address any observations or queries raised by the licensing authority or notified body.
- Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.
Manufacturing License Documents Required
The documentation for MD5 license must be meticulously prepared to avoid delays:
- Company Constitution (Incorporation Certificate, MOA, AOA)
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing process. For guidance, see our Device Master File guide.
- Plant Master File (PMF): Infrastructure, equipment, and facility details. Learn more from our Plant Master File guide.
- Essential Principles Compliance Checklist
- Risk Management File aligned with ISO 14971 standards (refer to our Risk Management guide)
- Product Test Reports from government-approved labs (Testing Laboratories List)
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process (MD15) for Bulk Oxygen Concentrators
While this guide primarily focuses on manufacturing, importers must obtain an MD15 import license from the Central Licensing Authority. This process takes approximately 5-6 months and requires documents such as the manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License.
Detailed guidance on import licensing is available in 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
- Plant Master File
- Wholesale License
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 2 months |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application | Submission via CDSCO portal |
| Audit by Notified Body | 3 – 4 weeks |
| Query Resolution and Approval | 2 – 3 weeks |
| Total Estimated Time | 3 – 4 months |
Government Fees and Costs
- Test License Fee: Included in overall process
- MD5 License Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
- Additional Costs: Testing fees at notified laboratories, audit fees charged by notified bodies (varies)
Budgeting for these costs upfront ensures smoother financial planning.
Common Challenges and Practical Solutions
- Incomplete Documentation: Many applicants face delays due to insufficient technical files or missing certificates. Solution: Use our detailed checklists to prepare comprehensive device and plant master files.
- Delays in Product Testing: Testing backlogs at government labs can extend timelines. Solution: Engage with notified labs early and consider parallel preparation of documents.
- Audit Non-Compliance: Non-adherence to QMS or facility standards leads to audit observations. Solution: Conduct internal pre-audits and gap assessments before official audits.
- Query Resolution Delays: Slow response to queries prolongs approval. Solution: Assign dedicated regulatory personnel for prompt communication.
Expert Consultation and Support
With our in-depth expertise in CDSCO licensing and regulatory affairs, we provide end-to-end support:
- Preparation and review of technical documentation
- Coordination with notified bodies and testing labs
- Application submission and tracking via the CDSCO MD Online Portal
- Audit readiness and mock audits
- Query management and liaison with CDSCO officials
Our proven methodology has helped over 500 clients achieve compliance efficiently and cost-effectively.
Getting Started with Your CDSCO License Application for Bulk Oxygen Concentration Systems
- Assess Device Classification: Confirm Class A status and applicable standards.
- Initiate Test License Application: Submit Form MD13 through the CDSCO portal.
- Engage with Notified Testing Labs: Schedule product testing promptly.
- Compile Technical Documentation: Prepare DMF, PMF, risk management, and QMS files in parallel.
- Select Notified Body for Audit: Refer to the Notified Bodies List and appoint early.
- Submit MD5 License Application (Form MD3): After completing testing and document preparation.
- Prepare for Audit: Conduct internal checks and address non-conformities.
- Respond Promptly to Queries: Ensure timely communication with CDSCO and auditors.
Embarking on this structured approach will help you navigate the regulatory landscape smoothly and secure your manufacturing license within the expected 3-4 month timeframe.
For tailored assistance or to kickstart your Bulk Oxygen Concentration System licensing journey, contact our regulatory experts today and leverage our 25+ years of CDSCO licensing excellence.
