CDSCO License for Hepatic function analysis system
Medical Device Information
Intended Use
An assembly of mains electricity (AC-powered) devices intended to aid in the quantitative assessment of liver function by the in vivo measurement of the plasma concentration and clearance of a tracer substance [e.g., indocyanine green (ICG)] in the peripheral vasculature following intravenous injection.
Comprehensive Guide to CDSCO Licensing for Hepatic Function Analysis System (Class B Medical Device)
Introduction: Understanding Hepatic Function Analysis Systems and Regulatory Importance
Hepatic function analysis systems are critical medical devices used in urology and hepatology to quantitatively assess liver function. These AC-powered assemblies measure plasma concentration and clearance of tracer substances like indocyanine green (ICG) in peripheral vasculature following intravenous injection. Given their clinical significance in diagnosing liver conditions, regulatory compliance is paramount to ensure safety, efficacy, and market access in India.
We have supported over 500 companies in navigating the complexities of CDSCO licensing. This guide specifically addresses regulatory pathways for Class B devices like hepatic function analysis systems, helping manufacturers and importers understand the requirements and streamline their application process.
CDSCO Regulatory Framework for Hepatic Function Analysis System
In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Hepatic function analysis systems fall under Class B due to moderate risk, requiring a manufacturing license from the State Licensing Authority under the MD5 category.
The regulatory framework demands adherence to quality standards, clinical safety, and conformity assessment before granting market authorization. The device is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, confirming its classification and regulatory oversight.
Risk Classification and License Requirements for Class B Devices
Class B devices, including hepatic function analysis systems, are considered low to moderate risk. According to CDSCO:
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Authority: State Licensing Authority
- Application Form: MD3 for license application
- Testing License: Required (Form MD13)
The Medical Device Classification guide can help confirm specific risk classes.
Manufacturing License Process for MD5 (Class B Devices)
The MD5 license process involves several critical steps:
Apply for Test License (Form MD13): Obtain a test license to manufacture samples for testing. This step takes approximately 1.5 to 2 months.
Product Testing: Submit samples to CDSCO-approved laboratories for conformance testing. You can find a list of approved testing laboratories here.
Document Preparation: Compile the required technical and quality documents.
Submit MD5 License Application (Form MD3): Apply online via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an audit of the manufacturing facility. Reference the list of notified bodies for audit assignment.
Query Resolution: Address any queries raised by CDSCO or the notified body during review.
Grant of Manufacturing License (Form MD5): Upon successful review and audit, the license is granted.
Manufacturing License Documents Required for Hepatic Function Analysis Systems
For Class B devices, the documentation is comprehensive and includes:
- Company Constitution Documents (e.g., Incorporation Certificate)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Records
- Fire Safety NOC and Pollution Control NOC
- Device Master File (DMF): Detailed design and manufacturing information (Guide to DMF)
- Plant Master File (PMF): Information regarding manufacturing facilities (PMF Guide)
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Hepatic Function Analysis Systems
If you plan to import hepatic function analysis systems into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process involves:
- Document preparation including Manufacturing License, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device Master File, Plant Master File, Wholesale License, and Company Constitution
- Submission of application on Form MD14 through the CDSCO MD Online Portal
- Queries response
- License grant on Form MD15
The typical timeline for import license processing ranges from 5-6 months.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate issued by the competent authority
- ISO 13485:2016 QMS Certificate
- CE Certification (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License in India
- Company Constitution and Address Proof
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| MD5 License Application | 1 month |
| Audit and Review | 1 to 1.5 months |
| Query Resolution and Grant | 2 to 4 weeks |
Total Time for MD5 License: Approximately 3-4 months
For imports, the MD15 license process typically spans 5-6 months.
Government Fees and Costs
For Class B Hepatic Function Analysis Systems:
MD5 Manufacturing License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500
Test License (MD13): No separate government fees, but testing lab fees apply.
Import License (MD15):
- Site Fee: $2,000 USD
- Per Product Fee: $1,000 USD
Additional costs include testing laboratory fees, notified body audit charges, and consultancy if opted.
Common Challenges and Solutions
Challenge: Delays in product testing due to sample rejection or incomplete documentation.
- Solution: Pre-validate samples and ensure compliance with test protocols before submission.
Challenge: Audit non-compliance due to inadequate QMS or facility issues.
- Solution: Conduct internal audits and gap assessments prior to notified body visits.
Challenge: Confusion over document requirements leading to application rejection.
- Solution: Use detailed checklists and consult experienced regulatory experts.
Challenge: Long query resolution times.
- Solution: Respond promptly and comprehensively with supporting evidence.
Expert Consultation and Support
Our 25+ years of experience enable us to provide tailored support for hepatic function analysis system manufacturers and importers. From pre-submission audits, document preparation, to regulatory strategy and liaison with CDSCO, our expert team ensures a smooth licensing journey.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status and understand applicable regulations.
- Prepare Your Technical Documentation: Develop or update your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (MD13): Submit initial application for manufacturing test samples through the CDSCO MD Online Portal.
- Arrange Sample Testing: Coordinate with CDSCO-approved labs for timely testing.
- Compile Quality and Compliance Documents: Gather all mandatory documents as outlined.
- Submit MD5 License Application (Form MD3): Apply online and schedule notified body audit.
- Respond to Queries Promptly: Maintain open communication with regulators.
By following these actionable steps, you can efficiently achieve CDSCO licensing for your hepatic function analysis system and access the Indian healthcare market with confidence.
For detailed assistance, refer to our MD5 License Guide and contact our regulatory experts to get started.
