CDSCO License for Suction system portable, Electrical/Pneumatic
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 generates negative pressure used for such treatment as the aspiration of liquid or granular substances.
Comprehensive Guide to CDSCO Licensing for Portable Suction Systems (Electrical/Pneumatic) - Class A Medical Device
As seasoned regulatory consultants with over 25 years of experience and having successfully assisted over 500 companies, we understand the complexities involved in acquiring CDSCO licenses for medical devices like the portable electrical/pneumatic suction system. This device, classified as Class A, is a vital component in operation theatres, used to generate negative pressure for the aspiration of liquids or granular substances. Ensuring compliance with India’s medical device regulations is crucial to legally manufacture or import this device into the Indian market.
Understanding the CDSCO Regulatory Framework for Portable Suction Systems
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules (MDR) 2017. Your suction system, notified under File No. 29/Misc/03/2020-DC (199) on 13.09.2021, falls under Class A — the lowest risk category. This classification impacts the licensing route, regulatory requirements, and oversight levels.
Risk Classification and License Requirements for Class A Devices
Class A devices like your portable suction system are considered low-risk devices. Hence, the manufacturing license is issued by the State Licensing Authority through the MD5 license process, governed by Application Form MD3. The entire approval cycle typically takes 3 to 4 months, including obtaining a test license and completing audits.
Manufacturing License Process (MD5) for Portable Suction Systems
The MD5 licensing process involves several key steps:
Obtain a Test License (Form MD13): This initial step allows you to manufacture the device under test conditions while performing required laboratory testing. Expect a processing time of approximately 1.5 to 2 months.
Product Testing: Testing must be conducted at CDSCO-approved government laboratories to validate safety and performance. Refer to the list of approved testing laboratories for selection.
Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission (Form MD3): Submit your application via the CDSCO MD Online Portal for the manufacturing license.
Audit by Notified Body: A notified body will conduct a factory audit to verify compliance. You can check the list of notified bodies authorized for Class A devices.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon successful audit and document verification, the State Licensing Authority issues the manufacturing license.
Manufacturing License Documents Required
For your suction system, ensure the following documentation is prepared meticulously:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Premises
- Qualification and Experience Certificates of Technical Staff
- No Objection Certificates (Fire Safety, Pollution Control)
- Detailed Device Master File outlining design, components, and specifications (see our Device Master File guide)
- Comprehensive Plant Master File describing manufacturing processes and quality control (Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File conforming to ISO 14971 standards (Risk Management insights)
- Test Reports from approved laboratories
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Portable Suction Systems
If you plan to import the device instead of manufacturing locally, the process involves obtaining an MD15 import license from the Central Licensing Authority. This process is more stringent, generally taking 5 to 6 months, and does not require a test license.
Key steps include:
- Comprehensive document preparation including Manufacturing License of foreign manufacturer, Free Sale Certificate, CE Certificate, Device and Plant Master Files
- Submission of application via the CDSCO MD Online Portal
- Resolution of any regulatory queries
- License grant on Form MD15
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate issued by the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| MD5 (Manufacturing) | 3-4 months | Test license (1.5-2 months), testing, audit, license grant |
| MD15 (Import) | 5-6 months | Document preparation, application, queries, license grant |
Government Fees and Costs
For your Class A suction system:
- MD5 License: Rs 5,000 per application + Rs 500 per product
- MD15 Import License: Approximately 50 per product
Note that additional costs may include notified body audit fees, laboratory testing fees, and costs related to document preparation.
Common Challenges and Practical Solutions
- Delayed Testing Results: To avoid bottlenecks, pre-schedule testing with government-approved labs and ensure samples comply with testing requirements.
- Incomplete Documentation: Utilize our detailed Device Master File guide and Plant Master File guide to prepare thorough dossiers.
- Audit Non-Compliance: Conduct internal audits before notified body visits and train staff on regulatory expectations.
- Query Management Delays: Provide prompt, clear, and comprehensive responses to CDSCO queries to expedite approval.
Expert Consultation and Support
Our consultancy has guided hundreds of manufacturers through the nuances of CDSCO licensing, ensuring timely approvals and compliance. We offer end-to-end support including:
- Gap analysis and readiness assessments
- Document drafting and review
- Liaison with notified bodies and CDSCO officers
- Training on regulatory compliance and audit preparedness
Getting Started with Your CDSCO License Application
Determine your licensing route: For your Class A portable suction system, initiate the MD5 license process with your respective State Licensing Authority.
Prepare initial documentation: Begin compiling company documents, technical staff qualifications, and manufacturing site details.
Apply for the Test License (Form MD13): Submit this application through the CDSCO MD Online Portal to start manufacturing under controlled conditions.
Schedule product testing: Coordinate with government-approved laboratories early to plan sample testing.
Develop comprehensive device and plant master files: Leverage our guides to meet CDSCO expectations.
Engage with a notified body: Arrange for pre-audit consultancy and formal audit scheduling.
Submit full MD5 license application (Form MD3): Upon successful testing and documentation, proceed with the formal license application.
Embarking on your CDSCO licensing journey with proper planning and experienced guidance will significantly improve your chances of timely approval and market entry. Contact us today to access personalized support and streamline your regulatory compliance for your portable suction system.
For more detailed insights on the MD5 licensing process, explore our MD5 License Guide.
