CDSCO License for Clinical color change thermometer.
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 clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature.
Introduction to Clinical Color Change Thermometer and Its Regulatory Importance
Clinical color change thermometers are disposable medical devices designed to measure body temperature via oral, rectal, or axillary routes. Widely used in hospitals and clinics, these instruments fall under the General Hospital or Orthopaedic Instruments category. Due to their direct contact with patients and critical diagnostic role, regulatory compliance with CDSCO (Central Drugs Standard Control Organization) in India is mandatory to ensure safety and efficacy.
As a device classified under Risk Class A, the clinical color change thermometer is considered low risk but still requires a valid manufacturing license to enter the Indian market legally. With over 25 years of experience and having supported 500+ companies, we provide comprehensive insights into the CDSCO licensing process tailored specifically for this device.
CDSCO Regulatory Framework for Clinical Color Change Thermometers
The CDSCO regulates medical devices in India under the Medical Device Rules, 2017. The clinical color change thermometer is notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, explicitly categorizing it as a Class A device.
Manufacturers must comply with the Medical Device Rules, which involve obtaining a manufacturing license (MD5) from the State Licensing Authority. The process ensures that the product meets quality, safety, and performance standards before market entry.
Risk Classification and License Requirements for Clinical Color Change Thermometers
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
Class A devices are subject to less stringent regulatory controls compared to higher classes, but manufacturers must still obtain the MD5 license by following the prescribed procedures, including product testing and audit.
Manufacturing License Process (MD5) for Clinical Color Change Thermometers
The MD5 license process for Class A devices like clinical color change thermometers typically spans 3 to 4 months and consists of the following key steps:
- Test License Application (Form MD13): Apply for a test license to manufacture and test products, which takes approximately 1.5 to 2 months.
- Product Testing: Submit samples to CDSCO-approved laboratories for performance and safety testing. Testing duration varies but generally completes within 4 to 6 weeks.
- Document Preparation: Compile all required technical and quality documentation.
- License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.
- Audit: Undergo an audit by a notified body listed on the Notified Bodies List to verify compliance.
- Query Resolution: Address any queries raised by the licensing authority or notified body.
- License Grant: Upon satisfactory compliance, the State Authority grants the MD5 license in Form MD5.
Manufacturing License Documents Required for Clinical Color Change Thermometers
To ensure smooth processing, prepare the following documents meticulously:
- Company Constitution (Memorandum & Articles of Association)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed device specifications, manufacturing processes, and quality controls (Device Master File Guide)
- Plant Master File (PMF): Description of the manufacturing facility and its controls (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety standards
- Risk Management File documenting hazard analyses and mitigations (Risk Management)
- Test Reports from approved laboratories (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485 compliant
Import License Process (MD15) for Clinical Color Change Thermometers
Though primarily focused on manufacturing, importers of clinical color change thermometers require an MD15 import license granted by the Central Licensing Authority. The process takes approximately 5 to 6 months and involves:
- Preparation of comprehensive documents including manufacturing license from the origin country, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
- Application submission through the CDSCO MD Online Portal.
- Resolution of departmental queries.
- License grant on Form MD15.
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| Step | Estimated Timeframe |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 4 to 6 weeks |
| Document Preparation & Submission | Concurrent with testing |
| Audit by Notified Body | 3 to 4 weeks |
| Query Resolution & Final Approval | 3 to 4 weeks |
| Total Duration (MD5 License) | Approximately 3 to 4 months |
Government Fees and Costs
- Application fee: Rs. 5,000 per application
- Product fee: Rs. 500 per product
These fees are payable online through the CDSCO MD Online portal. Additional costs may include fees for testing laboratories and notified body audits.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants face delays due to missing or improperly prepared documents. We recommend using detailed checklists and templates to avoid this.
- Audit Non-Compliance: Failing notified body audits due to inadequate QMS or facility issues is common. Conduct internal pre-audits to identify gaps.
- Testing Delays: Testing laboratories may have backlogs; submitting samples early and choosing the right lab helps reduce wait times.
- Query Management: Timely and comprehensive responses to CDSCO queries prevent prolonged delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time manufacturers. Our expert consultancy, leveraging 25+ years of experience and 500+ successful licenses, offers:
- Personalized gap analysis and document preparation
- Coordination with notified bodies and testing laboratories
- Pre-audit assessments and QMS implementation support
- End-to-end application submission and query handling
Getting Started with Your CDSCO License Application for Clinical Color Change Thermometers
- Assess your device classification and license type: Confirm your device is Class A and requires an MD5 license.
- Prepare your technical and quality documentation: Use our guides on Device Master File and Plant Master File to ensure compliance.
- Apply for the Test License (Form MD13): Submit your application via the CDSCO MD Online Portal.
- Send product samples for testing: Choose from CDSCO-approved Testing Laboratories.
- Coordinate audit scheduling: Engage with a notified body from the official Notified Bodies List.
- Submit your MD5 manufacturing license application (Form MD3): After successful testing and document finalization.
- Stay proactive in query resolution: Promptly respond to any clarifications from CDSCO or notified bodies.
By following these steps and leveraging expert support, manufacturers can efficiently secure their CDSCO MD5 license for clinical color change thermometers and confidently enter the Indian medical device market.
