CDSCO License for Cardiopulmonary resuscitation board.
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
Intended to be placed under a patient to act as a support during cardiopulmonary resuscitation.
Comprehensive Guide to CDSCO Licensing for Cardiopulmonary Resuscitation Board (Class A Medical Device)
Manufacturers and importers aiming to market the Cardiopulmonary Resuscitation (CPR) Board in India need to comply with the Central Drugs Standard Control Organization (CDSCO) regulatory framework. As a critical support device used during resuscitation, this Class A medical device is categorized under General Hospital or Orthopaedic Instruments, notified under Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
With over 25 years of regulatory consulting experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide you with detailed, actionable insights to streamline your licensing journey.
CDSCO Regulatory Framework for Cardiopulmonary Resuscitation Board
Under Indian regulations, the CPR Board is classified as a Class A medical device, which indicates a low-risk profile. The regulatory framework mandates obtaining a manufacturing license from the State Licensing Authority via Form MD3, leading to the issuance of an MD5 license. This process encompasses product testing, documentation, audits by notified bodies, and strict adherence to quality and safety standards.
For manufacturers, compliance with the Medical Device Rules, 2017, along with adherence to the Essential Principles of Safety and Performance, is compulsory.
Risk Classification and License Requirements
- Risk Class: A (Low Risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Authority: State Licensing Authority
Class A devices like the CPR Board require a relatively streamlined license process, including a mandatory test license (Form MD13) for product testing before the final manufacturing license grant.
Manufacturing License Process (MD5) for CPR Board
- Apply for Test License (Form MD13): This initial step allows you to legally manufacture the device for testing purposes.
- Product Testing: Conducted at government-approved laboratories to verify compliance with applicable standards.
- Document Compilation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management Files, and more.
- Submit Manufacturing License Application (Form MD3): Apply through the CDSCO MD Online Portal.
- Audit by Notified Body: A notified body from the list of notified bodies will audit your manufacturing premises and quality management system.
- Query Resolution: Address any observations or queries raised by the department or notified body.
- License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is issued.
Manufacturing License Documents Required
For your CPR Board, the following documents are essential:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Details of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) outlining device specifications, design, and manufacturing process. Our detailed Device Master File guide can help you prepare this.
- Plant Master File (PMF) detailing the manufacturing facilities and quality systems. Learn how to create an effective PMF here.
- Essential Principles Checklist confirming adherence to safety and performance requirements
- Risk Management File demonstrating risk identification and mitigation steps; see our risk management guide for best practices
- Test Reports from government-approved laboratories (Testing Laboratories list)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, typically ISO 13485:2016 certified
Import License Process (MD15) for CPR Board
If you are importing the CPR Board, an MD15 import license from the Central Licensing Authority is required.
- Application Form: MD14
- Documents:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
The import license process typically takes 5-6 months and involves document scrutiny and query resolution. Apply through the CDSCO MD Online Portal.
Timeline and Processing Duration
| Process Stage | Timeline |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3-4 weeks |
| Document Preparation | 3-4 weeks |
| Manufacturing License Application (MD5) | 1 week (submission) |
| Notified Body Audit | 3-4 weeks |
| Query Resolution & License Grant | 2-3 weeks |
Total Estimated Time: Approximately 3-4 months from test license application to final MD5 license grant.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Per Product Fee: ₹500 per product
Additional costs may include:
- Testing fees at government-approved labs (varies by lab and test complexity)
- Notified body audit charges
- Consultancy fees if engaging expert support
Common Challenges and Solutions
- Delay in Product Testing: Coordinate early with notified government testing labs and submit complete samples to avoid delays.
- Incomplete Documentation: Use comprehensive checklists and templates to ensure all files such as DMF, PMF, and Risk Management Files are complete and compliant.
- Notified Body Audit Non-compliance: Conduct internal pre-audits and corrective action measures before the notified body visit.
- Query Resolution Delays: Respond promptly and provide clear, evidence-backed clarifications.
Our experience shows that manufacturers who proactively prepare and understand CDSCO expectations can significantly reduce approval time.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our seasoned consultants have helped over 500 companies obtain MD5 licenses smoothly. We offer:
- Customized document preparation support
- Pre-audit readiness assessments
- Regulatory strategy planning
- Liaison with CDSCO officials and notified bodies
Feel free to reach out for tailored assistance to expedite your CPR Board’s market entry.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your CPR Board as Class A from the Medical Device Classification database.
- Prepare Test Samples: Coordinate with approved testing laboratories early.
- Compile Required Documents: Leverage our Device Master File and Plant Master File guides for accuracy.
- Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal to initiate the process.
- Plan for Notified Body Audit: Select an appropriate notified body from the official list of notified bodies.
- Maintain Quality Management Systems: Ensure your QMS is ISO 13485:2016 compliant.
Taking these concrete steps will position your company for a successful CDSCO MD5 license grant, enabling you to manufacture and market the CPR Board in India with full regulatory compliance.
For detailed, device-specific support, contact us to tap into our 25+ years of expertise in Indian medical device regulations.
