CDSCO License for Suction system operated by vacuum

Comprehensive Guide to CDSCO Licensing for Suction Systems Operated by Vacuum (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ manufacturers and importers, we provide you with an in-depth, practical roadmap to obtaining your CDSCO license for a suction system operated by vacuum—a Class A medical device used in operation theatres for patient treatment by aspiration via negative pressure.

Understanding Your Device and Regulatory Importance

The suction system operated by vacuum is a critical device designed to aspirate liquids or granular substances at the bedside using the hospital's medical gas supply. Classified under Class A (low risk), this device requires strict compliance with CDSCO regulations to ensure safety and efficacy in clinical settings. Regulatory approval is mandatory before manufacturing or importing such devices into India.

CDSCO Regulatory Framework for Suction Systems (Class A)

Your device falls under the Operation Theatre category and is governed by the Ministry of Health and Family Welfare through the Central Drugs Standard Control Organization (CDSCO). The governing notification is File No. 29/Misc/03/2020-DC (199), dated 13.9.2021, which mandates manufacturers and importers to obtain an MD5 manufacturing license or MD15 import license respectively for Class A devices.

Risk Classification and License Requirements

According to CDSCO's Medical Device Rules, suction systems operated by vacuum are classified as Class A—the lowest risk category. For manufacturing, you must apply for an MD5 license (Form MD3) through the State Licensing Authority. Importers require the MD15 license from the Central Licensing Authority.

For a detailed overview of risk classification, we recommend reviewing the Medical Device Classification guide.

Manufacturing License Process (MD5) for Suction Systems

The manufacturing license process for Class A devices involves multiple steps:

Obtain Test License (Form MD13): Apply for a test license which typically takes 1.5 to 2 months. This temporary license allows you to conduct product testing.
Product Testing: Get your suction system tested by CDSCO-approved government laboratories. Refer to the Testing Laboratories list for authorized centers.
Document Preparation: Compile required technical and legal documents such as Device Master File, Plant Master File, Risk Management File, etc.
Submit Manufacturing License Application (Form MD3): Apply via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts a factory audit to verify compliance. Check the Notified Bodies list for authorized auditors.
Respond to Queries: Address any observations from the audit or CDSCO review.
Grant of MD5 License: Upon successful review, the license is issued in Form MD5.

Manufacturing License Documents Required

Preparing a comprehensive dossier is key to avoid delays. For your suction system, the following documents are essential:

Company Constitution and Registration Proof
Proof of Ownership or Lease of Manufacturing Premises
Technical Staff Qualification and Experience Certificates
Fire NOC and Pollution Control NOC
Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. Our Device Master File guide helps you create compliant DMFs.
Plant Master File (PMF): Manufacturing facility details and quality systems. Refer to our Plant Master File guide.
Essential Principles Checklist confirming compliance with safety standards
Risk Management File demonstrating hazard identification and mitigation, per Risk Management practices
Test Reports from government-approved labs
Product Labels and Instructions for Use (IFU)
Quality Management System (QMS) documentation (preferably ISO 13485 compliant)

Import License Process (MD15) Overview

If you plan to import the suction system, an MD15 license is mandatory. This is a central license with a processing time of 5-6 months. Import licensing requires:

Valid manufacturing license from the country of origin
Free Sale Certificate
ISO 13485:2016 certificate
CE Certificate or equivalent
Device Master File and Plant Master File
Wholesale license
Company registration documents

Application is made on the CDSCO MD Online Portal using Form MD14.

Timeline and Processing Duration

For Manufacturing License (MD5):

Test License (MD13): 1.5 to 2 months
Product Testing: 1 month (varies by lab workload)
Document preparation and application submission: 1 month
Factory audit and queries resolution: 1 to 1.5 months
Total Time: Approximately 3 to 4 months

For Import License (MD15):

Document preparation and application: 1 month
CDSCO review and queries: 4 to 5 months
Total Time: Approximately 5 to 6 months

Government Fees and Costs

For your Class A device manufacturing license (MD5):

Application fee: Rs 5,000 per application
Product fee: Rs 500 per product

For import license (MD15):

Site fee: USD 1,000
Product fee: USD 50 per product

Note: Fees are subject to revision by CDSCO. Always check the latest fee structure on the official portal.

Common Challenges and Solutions

Challenge 1: Delay in product testing

Solution: Pre-book testing slots at government-approved labs and prepare samples meticulously to avoid retesting.

Challenge 2: Incomplete documentation leading to queries

Solution: Use checklists from official guidelines and consult expert regulatory consultants to ensure dossier completeness.

Challenge 3: Audit non-compliance

Solution: Conduct internal mock audits and train your staff on CDSCO requirements beforehand.

Challenge 4: Navigating CDSCO portal complexities

Solution: Familiarize yourself with the CDSCO MD Online Portal and maintain all documents in the required digital formats.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for newcomers. Our team has supported over 500 companies through the entire journey—from test license procurement to final license grant. We offer:

Gap analysis of your current compliance status
Preparation of Device and Plant Master Files
Coordination with notified bodies and testing labs
Assistance in audit preparation and post-audit responses
End-to-end application filing and follow-up

Getting Started with Your CDSCO License Application

Step 1: Initiate your test license application (Form MD13) via the CDSCO MD Online Portal.

Step 2: Arrange for product testing at an authorized government laboratory.

Step 3: Simultaneously, start compiling your Device Master File and Plant Master File per CDSCO guidelines.

Step 4: Prepare your Quality Management System documentation aligned with ISO 13485.

Step 5: Once testing is complete, submit your MD5 license application (Form MD3) online.

Step 6: Coordinate with your notified body for the mandatory factory audit.

Step 7: Respond promptly and thoroughly to any queries raised during the evaluation process.

By following this structured approach, you can minimize delays and ensure a smooth licensing journey. Our expertise is at your disposal to guide you every step of the way—contact us to leverage 25+ years of regulatory excellence.

For further reading and detailed guides, explore our resources:

Your successful entry into the Indian medical device market begins with the right CDSCO license. Let us help you achieve it efficiently and compliantly.

CDSCO License for Suction system operated by vacuum

Medical Device Information

Important Notice for Class A Devices

Intended Use