CDSCO License for Liquid crystal forehead temperature strip
Medical Device Information
Intended Use
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes.
Comprehensive Guide to CDSCO Licensing for Liquid Crystal Forehead Temperature Strips (Class B)
As specialists with over 25 years of experience and having assisted 500+ manufacturers and importers in obtaining CDSCO licenses, we understand the complexities involved in navigating India's regulatory landscape. This guide focuses on the Liquid Crystal Forehead Temperature Strip, a Class B medical device used to monitor body temperature changes and fever detection, categorized under General Hospital or Orthopaedic Instruments (Notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022).
Understanding the CDSCO Regulatory Framework for Liquid Crystal Forehead Temperature Strips
In India, medical devices fall under the regulatory jurisdiction of the Central Drugs Standard Control Organization (CDSCO). For your device, classified as Class B, the regulatory framework mandates obtaining an MD5 Manufacturing License from the State Licensing Authority. This ensures your device complies with the Essential Principles of Safety and Performance before entering the Indian market.
Risk Classification and License Requirements
The liquid crystal forehead temperature strip is a Class B device according to the CDSCO’s risk classification, which groups devices based on potential risks to the patient and user. Class B devices require a Manufacturing License (Form MD3) under the MD5 category for local production. If you plan to import, an MD15 Import License from the Central Licensing Authority is required.
For detailed classification insights, refer to our Medical Device Classification guide.
Manufacturing License Process for MD5 (Form MD3)
The MD5 license process typically spans 3 to 4 months and involves several critical steps:
Test License (Form MD13): Initially, you must apply for a test license, which takes approximately 1.5 to 2 months. This allows you to legally test your device in CDSCO-approved laboratories.
Product Testing: Your liquid crystal forehead temperature strip must be tested at one of the government-approved labs to validate safety and performance. You can find a list of these Testing Laboratories here.
Document Preparation: Compile comprehensive documentation including your Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission: Submit your MD5 application (Form MD3) through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body listed here to verify manufacturing facility compliance.
Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
License Grant: Upon successful audit and document review, the MD5 license is granted.
For a detailed walkthrough, our MD5 License Guide offers valuable insights.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following key documents:
- Company Constitution and Incorporation Certificate: Proof of your business entity.
- Proof of Ownership or Lease of Manufacturing Premises: Valid documents supporting your manufacturing location.
- Technical Staff Qualification and Experience Certificates: Essential for compliance with regulatory norms.
- Fire NOC and Pollution Control NOC: Local authority clearances.
- Device Master File (DMF): Detailed product specifications, design, and manufacturing processes. Learn how to create a robust DMF in our Device Master File guide.
- Plant Master File (PMF): Details about your manufacturing facility and quality systems. Our Plant Master File guide can assist you.
- Essential Principles Checklist: Demonstrates compliance with Indian Medical Device Rules.
- Risk Management File: Documentation of risk assessment and mitigation strategies.
- Test Reports: From CDSCO-approved labs validating device performance.
- Labels and Instructions for Use (IFU): Clear, compliant user guidance.
- Quality Management System Documents: Typically ISO 13485:2016 certification.
Import License Process (MD15) for Liquid Crystal Forehead Temperature Strips
If you are an importer, the MD15 license is issued by the Central Licensing Authority and typically takes 5 to 6 months. Unlike manufacturing, a test license is not required. The process involves:
- Preparing comprehensive documentation (including Manufacturing License of the exporter, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Wholesale License).
- Submitting application on Form MD14 via the CDSCO MD Online Portal.
- Query resolution with CDSCO.
- Issuance of Import License (Form MD15).
For more details, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale drug license of the importer
- Company Constitution and identity proofs
Timeline and Processing Duration
| License Type | Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application, Lab Testing, Approval |
| MD5 Manufacturing | 3 - 4 months | Document prep, Audit, Query resolution |
| MD15 Import License | 5 - 6 months | Document prep, Application, Query resolution |
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- MD15 Import License: For Class B devices, Rs. 2,000 per site + Rs. 1,000 per product
Be mindful of additional costs such as testing fees, audit charges by notified bodies, and consultancy fees if you engage experts.
Common Challenges and Solutions
- Delayed Test Reports: Mitigate by choosing labs with shorter turnaround times listed on the CDSCO portal.
- Incomplete Documentation: Use detailed checklists and expert review to avoid rejections.
- Audit Non-Compliance: Conduct pre-audit internal assessments and train your team thoroughly.
- Query Resolution Delays: Respond promptly with comprehensive evidence and clarifications.
Expert Consultation and Support
Navigating CDSCO licensing can be daunting without specialized knowledge. Engaging experts with hands-on experience in device registration accelerates approvals and ensures compliance. We offer tailored support, from document preparation to audit readiness, ensuring your liquid crystal forehead temperature strips reach the Indian market swiftly.
Getting Started with Your CDSCO License Application
- Assess your device classification and confirm regulatory requirements.
- Prepare your Device Master File and Plant Master File based on our guides.
- Apply for the Test License (Form MD13) via the CDSCO MD Online Portal.
- Schedule product testing at a CDSCO-approved lab.
- Compile all required documents meticulously.
- Submit your MD5 license application (Form MD3) through the portal.
- Prepare for the notified body audit by reviewing compliance criteria.
- Respond promptly to queries to avoid processing delays.
By following this structured approach and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for liquid crystal forehead temperature strips and ensure a smooth market entry.
For further assistance or to initiate your application, contact our regulatory experts today.
