CDSCO License for Biosanitizer for Medical devices
Medical Device Information
Intended Use
Intended for surface disinfection of medical devices, non porous hard-surfaces, medical-equipment, units, as well as in-depth cleaning of small surfaces.
Comprehensive Guide to CDSCO Licensing for Biosanitizer Medical Devices (Class B PPE)
As seasoned regulatory consultants with over 25 years of experience and a track record of supporting 500+ companies, we understand the unique challenges manufacturers and importers face when entering the Indian medical device market. This guide covers everything you need to know about obtaining a CDSCO license for your Biosanitizer medical device, specifically classified as Class B under Personal Protective Equipment (PPE).
Introduction: Biosanitizer Device Overview and Regulatory Importance
The Biosanitizer is designed for surface disinfection of medical devices, non-porous hard surfaces, medical equipment, and even small intricate surfaces. Given its critical role in infection control within healthcare, regulatory compliance is non-negotiable. The Central Drugs Standard Control Organization (CDSCO) evaluates such devices rigorously to ensure safety and efficacy before market entry.
CDSCO Regulatory Framework for Biosanitizer (Class B PPE)
Under the Medical Device Rules 2017, Biosanitizers used for surface disinfection fall under Class B due to moderate risk levels. This classification mandates obtaining a Manufacturing License (MD5) from the State Licensing Authority before production and sale.
Risk Classification and License Requirements
- Device Class: B
- License Type: MD5 (Manufacturing License for Class A and B devices)
- Application Form: MD3
- Regulatory Authority: State Licensing Authority
This specific classification means you must first acquire a test license (Form MD13) before applying for the manufacturing license.
Manufacturing License Process (MD5) for Biosanitizer Devices
The MD5 licensing process typically spans 3 to 4 months and involves several critical steps:
Apply for Test License (Form MD13): This initial step takes about 1.5 to 2 months and allows you to manufacture prototype batches for testing.
Product Testing: Conduct mandatory tests at government-approved laboratories to verify compliance with applicable standards. Refer to the CDSCO recognized testing laboratories for selection.
Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, QMS documentation, and risk management files.
Application Submission: Submit your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body audit is mandatory to verify manufacturing compliance. Access the list of notified bodies approved for conducting audits.
Query Resolution: Address any observations or queries raised by the authority or notified body promptly.
License Grant: Upon satisfactory compliance, the MD5 license is issued.
For in-depth guidance, you may refer to our detailed MD5 License Guide.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following key documents:
- Company Constitution/Legal Entity Proof
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, formulations, manufacturing processes (Learn more)
- Plant Master File (PMF): Overview of manufacturing facility, equipment, and quality control measures (Learn more)
- Essential Principles Checklist verifying compliance with safety and performance requirements
- Risk Management File: Hazard analysis, mitigation strategies, and residual risk evaluation (See guide)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as SOPs, CAPA, and training records
Import License Process (MD15) for Biosanitizer Devices
If you plan to import Biosanitizer devices into India, you must obtain an MD15 Import License from the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device Master and Plant Master Files.
- Submission of application via the CDSCO MD Online Portal.
- Resolution of departmental queries.
- License grant on Form MD15.
For a comprehensive understanding, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | Concurrently ongoing |
| MD5 License Application | 1 – 1.5 months |
| Audit and Query Resolution | 1 month |
| Total | 3 – 4 months |
Government Fees and Costs
- MD5 Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Additional costs include testing fees paid to approved laboratories and audit fees payable to the notified body.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited slots at government labs.
Solution: Engage with testing laboratories early and consider private accredited labs if permissible.
Challenge: Incomplete or inconsistent documentation leading to repeated queries.
Solution: Invest time in thorough document preparation and pre-audit internal reviews.
Challenge: Audit non-compliance issues.
Solution: Conduct mock audits and ensure strict adherence to QMS and GMP.
Expert Consultation and Support
Navigating the CDSCO licensing maze can be daunting. Our expert team offers tailored consulting, from document preparation to audit support, ensuring your Biosanitizer device complies fully and enters the market swiftly. With a history of 500+ successful licenses, we bring unparalleled insights and practical solutions.
Getting Started with Your CDSCO License Application
- Register your company on the CDSCO MD Online Portal.
- Prepare and submit your Test License (MD13) application.
- Simultaneously, compile your Device Master File and Plant Master File.
- Schedule product testing at approved laboratories.
- Initiate QMS documentation and internal audits.
- Once test license is granted and testing completed, apply for the MD5 manufacturing license.
- Coordinate with a notified body for audit scheduling.
- Respond promptly to any queries to expedite approval.
By following these actionable steps and leveraging expert guidance, your Biosanitizer device will be positioned for successful regulatory approval in India’s dynamic medical device market.
