CDSCO License for Nitric oxide delivery unit, system-based
Medical Device Information
Intended Use
A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.
Understanding the Nitric Oxide Delivery Unit and Its Regulatory Importance
Nitric oxide delivery units are critical life-support systems used extensively in pediatrics and neonatology to manage severe respiratory disorders such as primary pulmonary hypertension (PPH) and acute respiratory distress syndrome (ARDS). These AC-powered devices, often equipped with rechargeable batteries, deliver precise doses of nitric oxide (NO) to patients via ventilators or respiratory systems. Given the device’s high risk class (Class C) and its direct impact on patient health, stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, efficacy, and quality.
As experienced regulatory consultants with over 25 years in the field and having assisted 500+ companies, we understand the nuances and complexities involved in obtaining CDSCO licenses for advanced medical devices like nitric oxide delivery systems. This guide will provide detailed, actionable insights into the regulatory framework, timelines, costs, and documentation required to successfully market your device in India.
CDSCO Regulatory Framework for Nitric Oxide Delivery Units (Class C Medical Devices)
The CDSCO governs medical device regulation under the Medical Device Rules (MDR) 2017, categorizing devices based on risk to patients. Nitric oxide delivery units fall under Class C due to their significant risk profile, necessitating central licensing authority approval.
To manufacture or import this device, companies must obtain the MD9 manufacturing license or MD15 import license respectively, ensuring compliance with all regulatory mandates, including quality management systems, technical documentation, and safety standards.
Risk Classification and License Requirements for Class C Devices
- Risk Class: C
- License Type: MD9 Manufacturing License (Form MD7) for manufacturing
- Import License: MD15 License (Form MD14) for import
- Regulatory Authority: Central Licensing Authority (CDSCO)
- Total Processing Time: Approximately 4–5 months for manufacturing license; 5–6 months for import license
Class C devices demand comprehensive testing, documentation, and audits to confirm adherence to essential principles and risk management guidelines. Our detailed experience helps clients navigate these steps seamlessly.
Manufacturing License Process for Nitric Oxide Delivery Units (MD9 License)
Obtaining an MD9 license for manufacturing involves several mandatory stages:
- Test License on Form MD13: Apply for a test license to produce the device samples for testing; typically processed within 1.5–2 months.
- Product Testing: Conduct mandatory testing of device samples at CDSCO-approved laboratories to verify compliance with Indian standards.
- Documentation Preparation: Compile detailed technical files including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
- License Application: Submit the manufacturing license application on Form MD7 via the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO inspectors audit your manufacturing facility and documentation to verify compliance.
- Query Resolution: Address any queries raised during the inspection or review process.
- Grant of License: Upon satisfactory compliance, CDSCO issues the MD9 manufacturing license.
For detailed guidelines, refer to our MD9 License Guide.
Manufacturing License Documents Required for MD9 License
To ensure a smooth application, prepare the following documents:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Documents
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and manufacturing processes (Learn More)
- Plant Master File (PMF) describing manufacturing environment and controls (Learn More)
- Essential Principles Checklist confirming compliance with MDR 2017
- Comprehensive Risk Management File per ISO 14971 standards (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories (List of Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, typically ISO 13485:2016 certification
Import License Process for Nitric Oxide Delivery Units (MD15 License)
For importers, the MD15 license is mandatory to legally bring the nitric oxide delivery units into India. The process is as follows:
- Document Preparation: Collate all required documents including manufacturing license from the country of origin, quality certificates, and technical files.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Review and Queries: CDSCO reviews your submission and may seek clarifications.
- Grant of License: On satisfactory review, the MD15 import license is granted.
Unlike manufacturing licenses, no test license is required for import.
Import License Documents Required for MD15 License
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certification
- CE Certificate or equivalent international conformity marking
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Incorporation Documents
- Product Labels and IFU
Fees vary by device class; for Class C devices, expect approximately 1500 per product.
Timeline and Processing Duration
| License Type | Processing Time | Key Steps Duration |
|---|---|---|
| MD9 Manufacturing | 4–5 months | Test License (1.5–2 months), Testing, Audit, Query Resolution |
| MD15 Import | 5–6 months | Document Review, Query Resolution |
Early preparation of documentation and proactive communication with CDSCO significantly reduces delays.
Government Fees and Costs for Nitric Oxide Delivery Units
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- MD15 Import License: Approximately 1,500 per product (Class C devices)
These fees cover application processing, inspection, and license issuance. Additional costs may include testing fees at approved laboratories and consultancy fees if you engage expert support.
Common Challenges and Practical Solutions
- Delayed Testing Results: Testing at government-approved labs can take time; we recommend early submission of samples and pre-coordination with labs.
- Incomplete Documentation: Many applicants face rejections due to missing or inconsistent documents. Utilize comprehensive checklists and expert review before submission.
- Audit Non-compliance: Prepare thoroughly for audits by ensuring your facility adheres to QMS and MDR 2017 requirements.
- Query Management: Respond promptly and comprehensively to CDSCO queries to avoid processing delays.
Our experience shows that companies investing in early preparation and expert consultation navigate these challenges effectively.
Expert Consultation and Support
With over 25 years of expertise and having supported 500+ medical device companies, we provide end-to-end regulatory assistance including:
- Gap analysis and readiness assessment
- Preparation of Device and Plant Master Files
- Risk management strategy implementation
- Application filing and liaison with CDSCO
- Audit preparation and mock inspections
Partnering with seasoned consultants accelerates your market entry and ensures regulatory compliance.
Getting Started with Your CDSCO License Application for Nitric Oxide Delivery Units
- Assess Device Classification: Confirm your device's Class C status and licensing requirements. Use resources like the Medical Device Classification Guide.
- Prepare Technical Documentation: Begin compiling Device and Plant Master Files, risk management, and QMS documents.
- Engage Testing Laboratories: Identify and coordinate with CDSCO-approved testing labs to schedule product testing early.
- Apply for Test License: For manufacturing, submit Form MD13 to obtain permission to produce samples for testing.
- Submit License Application: After testing, apply for MD9 manufacturing or MD15 import license via the CDSCO MD Online Portal.
- Plan for Audit and Queries: Prepare your facility and team for audits and be ready to resolve any queries timely.
Starting early and leveraging expert guidance increases your chances of a successful and timely CDSCO license grant for your nitric oxide delivery system. Contact us today to initiate your regulatory journey with confidence.
