CDSCO License for Personal Protective Equipment
Medical Device Information
Intended Use
PPE kit used to acts as a barrier between infectious materials such as viral and bacterial contaminants and skin, mouth, nose, or eyes. It refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
Comprehensive CDSCO Licensing Guide for Personal Protective Equipment (PPE) – Class B Medical Devices
As a trusted regulatory consultancy with over 25 years of experience and having guided more than 500 companies through successful CDSCO licensing, we understand the nuances involved in bringing Personal Protective Equipment (PPE) to the Indian market. PPE kits serve a critical role as barriers protecting wearers from infectious agents such as viruses and bacteria. Given their vital importance, regulatory compliance is key to ensuring safety and market access.
Understanding the CDSCO Regulatory Framework for Personal Protective Equipment
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. PPE falls under the category of medical devices as notified under File No. 29/Misc./03/2020-DC (186), dated 13.09.2021. This notification classifies PPE as a Class B medical device, which implies a low to moderate risk profile.
Manufacturers of PPE kits must obtain an MD5 manufacturing license issued by the State Licensing Authority before marketing their products in India. Importers, on the other hand, require an MD15 import license granted by the Central Licensing Authority.
Risk Classification and License Requirements for PPE Kits
- Device Name: Personal Protective Equipment (PPE)
- Risk Class: B (Low to Moderate Risk)
- Regulatory License: MD5 Manufacturing License (Form MD3) for domestic manufacturers
- Licensing Authority: State Drug Control Authority
The Class B designation entails compliance with essential principles, quality management systems, and testing requirements, which ensures safety and performance.
Step-by-Step Manufacturing License Process for PPE (MD5 License)
Obtain Test License (Form MD13):
- Duration: Approximately 1.5 to 2 months
- Purpose: Allows product testing at government-approved laboratories
Product Testing:
- Conduct tests at CDSCO-approved laboratories to validate compliance with applicable standards
- Refer to the list of testing laboratories for authorized labs
Document Preparation:
- Compile all required documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and others
Application Submission:
- Submit manufacturing license application on Form MD3 via the CDSCO MD Online Portal
Audit by Notified Body:
- Engage an authorized notified body for audit of manufacturing premises and quality systems
- Check the list of notified bodies for suitable auditors
Address Queries:
- Timely respond to any queries or deficiencies raised by CDSCO or notified body
Grant of License:
- Upon satisfactory compliance, license is granted on Form MD5
Essential Documents Required for MD5 Manufacturing License – PPE
- Company Constitution (Memorandum and Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire Safety NOC from local authorities
- Pollution Control Board Clearance (if applicable)
- Device Master File (Detailed product specifications, manufacturing process, and design)
- Plant Master File (Manufacturing setup, equipment details, and quality management system) – see our guide on Plant Master File
- Essential Principles Checklist demonstrating conformity to Indian regulations
- Risk Management File compliant with ISO 14971 – practical insights on Risk Management
- Test Reports from CDSCO-approved labs
- Labels, Instructions for Use (IFU) compliant with regulatory standards
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process for PPE (MD15 License)
For companies importing PPE kits into India, an MD15 license is mandatory. The process includes:
- No Test License Required: Unlike manufacturing, no test license is needed upfront.
- Document Preparation: Prepare and submit documents including free sale certificate, ISO 13485:2016, CE certificates, device and plant master files, wholesale license, and company constitution.
- Application Submission: Apply through Form MD14 on the CDSCO MD Online Portal.
- Queries Resolution: Respond promptly to departmental queries.
- Grant of License: License granted on Form MD15.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution
Timelines and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD5) | 3 to 4 months (including test license, testing, audit) |
| Import License (MD15) | 5 to 6 months |
Early preparation and thorough documentation can help reduce delays.
Government Fees and Costs
- MD5 License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
- MD15 Import License:
- For Class B devices: Rs 2,000 per site + Rs 1,000 per product
These fees are payable online during application submission via the CDSCO portal.
Common Challenges and Practical Solutions
- Delayed Testing: Limited slots in government-approved labs can delay testing; early booking and selecting alternative approved labs can mitigate this.
- Incomplete Documentation: Missing or inconsistent documents cause query loops; leveraging our document checklists and templates ensures completeness.
- Audit Non-Compliance: Non-adherence to QMS or GMP standards during notified body audit is common; pre-audit internal assessments can prevent audit failures.
- Regulatory Updates: Frequent rule changes can confuse; subscribing to CDSCO notifications and expert consultation keeps you updated.
Expert Consultation and Support
Navigating CDSCO regulations for PPE can be complex, especially for new manufacturers. Our consultancy offers:
- End-to-end application preparation
- Regulatory gap analysis
- Pre-audit readiness checks
- Training on QMS and risk management
- Liaison with CDSCO and notified bodies
Our expertise has helped over 500 companies successfully obtain CDSCO licenses, accelerating their time to market.
Getting Started with Your CDSCO License Application for PPE
- Classify Your Device Accurately: Confirm PPE is Class B using the Medical Device Classification guide.
- Gather Required Documents: Start compiling your Device Master File and Plant Master File early.
- Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal to initiate product testing.
- Schedule Laboratory Testing: Coordinate with approved labs to ensure timely test report delivery.
- Prepare for Audit: Select a notified body from the official list and conduct mock audits.
- Submit Manufacturing License Application: Complete Form MD3 submission online once testing and audit are successfully concluded.
- Address Queries Promptly: Engage experts to resolve any CDSCO or notified body queries efficiently.
By following these actionable steps and leveraging expert resources, manufacturers and importers can confidently navigate the CDSCO licensing process for Personal Protective Equipment and gain timely market access in India.
