CDSCO License for Atomizer
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 that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe.
Comprehensive Guide to CDSCO Licensing for Atomizer (Class A Medical Device)
Atomizers are vital anesthesiology devices designed to deliver liquid medication in aerosolized form, ensuring patients receive effective respiratory treatments. Given their direct impact on patient care, obtaining the appropriate CDSCO license is critical for manufacturers and importers aiming to market atomizers in India. With over 25 years of regulatory expertise and having assisted 500+ companies in securing CDSCO approvals, we provide you with detailed, practical guidance to navigate the licensing process smoothly.
CDSCO Regulatory Framework for Atomizer Devices
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Atomizers fall under the anesthesiology category and are classified as Class A devices, the lowest risk class. The regulatory pathway for Class A devices mandates compliance with specific manufacturing and quality standards to ensure safety and performance.
Risk Classification and License Requirements for Atomizers
Atomizers are classified as Class A devices per the government notification [29/Misc/03/2020-DC(177)] dated 12.07.2021. This classification implies a lower risk profile but still requires manufacturers to obtain an MD5 license from the State Licensing Authority. The MD5 license specifically authorizes the manufacturing of Class A and B devices within India.
Manufacturing License Process for Atomizers (MD5 License)
The MD5 license process involves several critical steps:
Test License Application (Form MD13): Obtain a test license allowing limited production for testing purposes. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing of the atomizer device at CDSCO-approved government laboratories. You can find the approved testing laboratories here.
Document Preparation: Compile detailed documentation, including Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documents, among others.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing site is conducted by a notified body listed here.
Query Resolution: Address any queries or observations raised by the licensing authority or notified body.
Grant of MD5 License: Upon successful compliance, the license is granted on Form MD5.
The entire process typically takes 3 to 4 months, depending on the preparedness of your documentation and the audit schedule.
Manufacturing License Documents Required for Atomizers
For the MD5 license, the following documents must be meticulously prepared and submitted:
- Company Constitution documents (e.g., Incorporation Certificate)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical and quality personnel
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design and specifications. Refer to our Device Master File guide for preparation insights.
- Plant Master File (PMF) describing manufacturing facilities. Learn more with our Plant Master File guide.
- Essential Principles Checklist complying with MDR 2017
- Risk Management File aligned with ISO 14971 standards. Our Risk Management guide can assist here.
- Product test reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU) documents
- Quality Management System manuals and SOPs
Ensure all documents are accurate and up to date to prevent processing delays.
Import License Process for Atomizers (MD15 License)
For importers of atomizers, an MD15 license from the Central Licensing Authority is mandatory. The process involves:
- Preparation of import-related documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), DMF and PMF, wholesale license, and company constitution.
- Submission of application using Form MD14 on the CDSCO MD Online Portal.
- Query resolution based on authority review.
- Final grant of the MD15 import license.
The import license process usually takes 5 to 6 months. Note that for Class A devices like atomizers, the government fees are approximately 50 per product.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | Concurrent |
| License Application & Audit | 1 to 1.5 months |
| Query Resolution | 2 to 4 weeks |
| Total Time | 3 to 4 months |
Manufacturers should proactively prepare documentation and schedule audits to avoid timeline extensions.
Government Fees and Costs
For atomizers (Class A devices), the fee structure is as follows:
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs include testing fees charged by government-approved labs and audit fees payable to notified bodies. Budgeting for these early can help mitigate financial surprises.
Common Challenges and Solutions
Challenge 1: Delays in Testing
- Solution: Engage with CDSCO-approved testing laboratories early. Submit samples promptly and maintain communication for status updates.
Challenge 2: Incomplete Documentation
- Solution: Use expert consultants or internal checklists to ensure all required documents, including the Device Master File and Risk Management File, meet regulatory expectations.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal mock audits before the notified body visit. Address facility and process gaps proactively.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory liaison to respond swiftly and comprehensively to queries raised by CDSCO or auditors.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially for first-time manufacturers or importers of atomizers. Our team, with over 25 years of experience and 500+ successful CDSCO applications, offers tailored regulatory consultancy. We assist with document preparation, audit readiness, test coordination, and online application submission on the CDSCO MD Online Portal, ensuring a streamlined licensing journey.
Getting Started with Your CDSCO License Application for Atomizers
Assess Device Classification: Confirm atomizer classification as Class A under the latest CDSCO notification.
Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Apply for Test License: Submit Form MD13 via the CDSCO portal to initiate the test license phase.
Schedule Product Testing: Coordinate with CDSCO-approved labs for mandatory product testing.
Plan for Audit: Identify a notified body from the official list and prepare your manufacturing site.
Submit MD5 Application: Complete and submit Form MD3 on the CDSCO portal post-testing and audit readiness.
Engage with Authorities: Respond promptly to any queries to expedite license grant.
By following these pragmatic steps and leveraging expert support, manufacturers and importers can successfully obtain their CDSCO MD5 license for atomizers and confidently enter the Indian market.
For detailed assistance and personalized consultation, feel free to connect with our regulatory experts.
