CDSCO License for Public respirator (2 ply, 3 ply face mask)
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 filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency.
Comprehensive Guide to CDSCO Licensing for Public Respirators (2 Ply, 3 Ply Face Masks) – Class A Medical Devices
In the wake of ongoing public health challenges, public respirators such as 2 ply and 3 ply face masks have become essential medical devices. These masks are designed to protect the general public by filtering airborne pathogenic particulates, playing a critical role in controlling infection spread during health emergencies. If you are a manufacturer or importer aiming to enter the Indian market, understanding the CDSCO regulatory framework for these Class A respiratory devices is paramount to ensure compliance and timely market access.
CDSCO Regulatory Framework for Public Respirators (Class A Devices)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules 2017. Public respirators, classified under Class A (low risk) devices, fall under the purview of the State Licensing Authority for manufacturing licenses. The recent notification (File No. 29/Misc/03/2020-DC(197), dated 6.8.2021) specifically covers these devices, streamlining their regulatory pathway.
Risk Classification and License Requirements
Public respirators such as 2 ply and 3 ply face masks are categorized as Class A devices due to their low risk profile. This classification means the following:
- Manufacturing License: MD5 license, granted by the State Licensing Authority
- Import License: Not applicable for manufacturing but if importing, MD15 license from Central Licensing Authority
For Class A devices, the entire manufacturing license process typically spans about 3-4 months.
Manufacturing License Process for Public Respirators (MD5 License)
Our extensive experience supporting over 500 companies shows that the MD5 license process involves several sequential steps for Class A devices:
- Obtain Test License (Form MD13): Before manufacturing license application, you must secure a test license which takes approximately 1.5 to 2 months.
- Product Testing: Conduct product testing at CDSCO-recognized laboratories to validate compliance with applicable standards.
- Document Preparation: Assemble all required documentation including Device Master File (DMF), Plant Master File (PMF), and Quality Management System (QMS) records.
- Apply for MD5 License (Form MD3): Submit your application on the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body will perform a facility audit; check the list of notified bodies to select an approved auditor.
- Resolve Queries: Address any queries raised by the department or notified body promptly to avoid delays.
- Grant of License: Upon successful audit and document verification, the MD5 license will be issued.
Manufacturing License Documents Required
To ensure a smooth application process, prepare the following documents meticulously:
- Company Constitution: Certificate of incorporation, partnership deed, etc.
- Proof of Ownership or Lease of Premises: Valid property documents
- Details of Technical Staff: Qualifications and experience certificates
- Fire NOC and Pollution Control NOC: From local authorities
- Device Master File (DMF): Detailed device specifications, design, manufacturing process (DMF Guide)
- Plant Master File (PMF): Facility layout, equipment details (PMF Guide)
- Essential Principles Checklist: Compliance checklist confirming safety and performance
- Risk Management File: Risk analysis and mitigation strategies (Risk Management Insights)
- Test Reports: From CDSCO-approved testing labs (Testing Laboratories)
- Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
- Quality Management System Documents: ISO 13485 certification and internal policies
Import License Process for Public Respirators (MD15 License)
For importers of public respirators, an MD15 license from the Central Licensing Authority is mandatory. The process involves:
- Comprehensive document submission including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, and more.
- Application via the CDSCO MD Online Portal
- Processing time of approximately 5-6 months
Import License Documents Required
Key documents include:
- Valid manufacturing license of the product
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
Timeline and Processing Duration
| License Type | Duration | Notes |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Mandatory first step before manufacturing license |
| Manufacturing License (MD5) | 3 - 4 months | Includes audit and query resolution |
| Import License (MD15) | 5 - 6 months | No test license required |
Government Fees and Costs
The fee structure for Class A public respirators is as follows:
MD5 Manufacturing License:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD15 Import License:
- Application Fee: Approx USD 1,000 per site + USD 50 per product
Additionally, costs for testing, notified body audits, and document preparation should be budgeted accordingly. Our experience shows that proactive planning reduces unexpected expenses.
Common Challenges and Practical Solutions
Challenge 1: Delays in Document Preparation
- Solution: Begin compiling the Device Master File and Plant Master File early, leveraging expert templates.
Challenge 2: Test Lab Backlogs
- Solution: Select less busy CDSCO-approved labs from the Testing Laboratories list and schedule in advance.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits to identify gaps before the notified body visit.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated compliance officer to promptly address and respond to CDSCO queries.
Expert Consultation and Support
With over 25 years of regulatory consulting experience and more than 500 successful CDSCO license acquisitions, we provide end-to-end support:
- Tailored document preparation assistance
- Liaison with notified bodies and testing labs
- Comprehensive audit readiness training
- Guidance on labeling and risk management
Our deep understanding of nuances in Class A device licensing ensures your application progresses efficiently.
Getting Started with Your CDSCO License Application for Public Respirators
- Assess Your Device Classification: Confirm your public respirator is Class A using the Medical Device Classification resource.
- Prepare Testing and Facility Documentation: Begin compiling your DMF, PMF, and risk files.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to initiate the process.
- Schedule Product Testing: Coordinate with approved laboratories early to avoid bottlenecks.
- Engage a Notified Body for Audit: Identify and contract an appropriate auditor from the Notified Bodies List.
- Submit Manufacturing License Application (MD3): Post-testing and documentation, apply online.
- Prepare for Audit and Queries: Address all observations swiftly to expedite license grant.
Starting early and following this structured approach dramatically improves your chances of a smooth, timely CDSCO license grant for your public respirators.
For personalized assistance or to explore our proven strategies, connect with our regulatory experts today and secure your market entry with confidence.
