CDSCO License for Dental suction system fluid-separation unit
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 separator used in the oral cavity. Used for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry suction).
Comprehensive Guide to Obtaining CDSCO License for Dental Suction System Fluid-Separation Unit (Class A)
Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to enter the market with specialized products like the Dental suction system fluid-separation unit. This device, classified as Class A under the CDSCO framework, plays a critical role in dental care by separating fluids such as saliva and blood from gases to protect suction pumps. With over 25 years of industry experience and assisting more than 500 companies in securing CDSCO licenses, we provide an authoritative, step-by-step guide tailored specifically for this device.
Understanding the CDSCO Regulatory Framework for Dental Suction System Fluid-Separation Units
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, amended periodically. The Dental suction system fluid-separation unit falls under the dental category and is notified as per the official notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
Being a Class A medical device indicates a low-risk profile, which corresponds to a streamlined regulatory pathway governed by the State Licensing Authority.
Risk Classification and License Requirements for Class A Dental Devices
Class A devices are considered low risk and therefore require the MD5 license, which is issued by the State Licensing Authority. The process involves a test license phase, product testing, document submission, audit by a notified body, and final license grant.
For a dental suction system fluid-separation unit, the MD5 license process ensures compliance with quality, safety, and performance standards set forth by CDSCO.
Detailed Manufacturing License Process (MD5) for Dental Suction System Fluid-Separation Unit
Test License Application (Form MD13)
- Submit an application for a test license on the CDSCO MD Online Portal.
- This initial step allows you to manufacture the device for testing purposes.
- Timeline: 1.5 to 2 months.
Product Testing
- Conduct mandatory testing of the device in government-approved labs to verify compliance.
- Refer to the list of government-approved testing laboratories for selection.
- Testing typically covers biocompatibility, fluid separation efficacy, and material safety.
Document Preparation & Submission (Form MD3)
- Prepare and submit the final manufacturing license application.
- Application Form: MD3 for MD5 license.
- Submit via the CDSCO MD Online Portal.
Audit by Notified Body
- An audit of manufacturing facilities and quality systems is conducted by a notified body.
- Choose from the list of notified bodies accredited for Class A devices.
- Audit covers compliance with ISO 13485, GMP, and MDR requirements.
Queries & Clarifications
- Address any queries raised by the State Licensing Authority or notified body promptly to avoid delays.
License Grant (Form MD5)
- Upon successful audit and document review, the MD5 manufacturing license is granted.
Essential Documents Required for MD5 Manufacturing License
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution (Partnership deed, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification & Experience Details (including biomedical engineers, quality managers)
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF) detailing specifications, manufacturing process, and design
- Plant Master File (PMF) describing the manufacturing environment and controls
- Essential Principles Checklist confirming compliance with MDR
- Risk Management File demonstrating identification and mitigation of potential hazards
- Test Reports from approved laboratories
- Labels and Instructions for Use (IFU) complying with CDSCO labeling norms
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
For detailed insights, refer to our comprehensive Device Master File guide and Plant Master File guide.
Import License Process for Dental Suction System Fluid-Separation Unit (MD15)
If you are an importer, the process requires obtaining the MD15 import license, granted by the Central Licensing Authority. Unlike the manufacturing license, a test license is not mandatory here.
Steps include:
- Preparing and submitting the import license application on Form MD14 through the CDSCO portal.
- Providing documents such as the manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, device and plant master files, and wholesale license.
- Responding to any departmental queries.
The MD15 license process typically takes 5-6 months.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation & Submission | 2 weeks – 1 month |
| Audit by Notified Body | 1 month |
| Query Resolution & License Grant | 2 – 3 weeks |
Total Estimated Time: Approximately 3-4 months for the entire MD5 license process.
Government Fees and Costs
- MD5 License Application Fee: Rs. 5,000 per application.
- Product Fee: Rs. 500 per product.
- Test License Fee (MD13): Typically included in application fees or nominal.
Additional costs to consider:
- Fees for notified body audit (varies by body).
- Testing charges at government-approved labs.
- Consultancy or documentation preparation fees (if applicable).
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with testing labs early and confirm their capacity and timelines. Pre-book slots if possible.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and templates from experienced consultants. Ensure that your Device Master File and Risk Management File are thorough.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal audits and mock inspections to identify gaps before the notified body audit.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory affairs expert to handle and respond promptly to CDSCO queries.
Expert Consultation and Support
Our team has successfully guided over 500 companies through the CDSCO licensing maze for dental and other medical devices. Leveraging our expertise ensures:
- Precise classification and regulatory strategy.
- Accurate and complete documentation.
- Coordination with notified bodies and testing labs.
- Timely application submissions via the CDSCO MD Online Portal.
We also provide detailed training on MDR compliance, risk management implementation, and post-market surveillance.
Getting Started with Your CDSCO License Application for Dental Suction System Fluid-Separation Unit
Confirm Device Classification: Verify your device as Class A based on the official medical device classification list.
Set Up Your Quality Management System: Ensure ISO 13485:2016 certification and implement robust risk management practices.
Prepare Essential Documentation: Develop your Device Master File, Plant Master File, Risk Management File, test protocols, and labeling.
Apply for Test License (MD13): Start the process early to gain manufacturing rights for testing.
Engage Accredited Testing Labs: Choose from the CDSCO-approved testing laboratories to validate your product.
Schedule Notified Body Audit: Select a notified body experienced with Class A devices from the notified bodies list and prepare for the audit.
Submit Final Application (MD3) for MD5 License: Apply through the CDSCO portal and track your application status.
Respond to Queries Promptly: Ensure quick and thorough responses to avoid unnecessary delays.
By following these actionable steps and leveraging expert support, you can efficiently secure your CDSCO manufacturing license and successfully launch your dental suction system fluid-separation unit in the Indian market.
For in-depth help, refer to our dedicated MD5 License Guide and contact us for personalized consultancy.
Embark on your regulatory journey with confidence and compliance—partner with seasoned experts to transform your innovative dental device into a market-ready product.
