CDSCO License for Pneumatic Tourniquet & its attachment
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
The tourniquet used for stopping flow of blood through artery by compression. The attachment includes Consol unit & cuffs.
Comprehensive Guide to CDSCO Licensing for Pneumatic Tourniquet & Its Attachments (Class A Medical Device)
As seasoned medical device regulatory consultants with over 25 years of experience and having supported more than 500 companies in India, we understand the critical importance of a smooth CDSCO licensing process. The Pneumatic Tourniquet and its attachments, including console units and cuffs, are classified as Class A medical devices under the category of General Hospital or Orthopaedic Instruments. Given their intended use—to stop blood flow through arteries by compression—these devices are vital in surgical procedures and require strict regulatory compliance.
This guide provides an expert, step-by-step overview tailored specifically for manufacturers and importers seeking to obtain a CDSCO license for Pneumatic Tourniquets in India.
CDSCO Regulatory Framework for Pneumatic Tourniquet & Attachments
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Devices Rules 2017. Pneumatic Tourniquets fall under Class A (low risk) devices as per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
The regulatory framework mandates manufacturers of Class A devices to obtain a manufacturing license (MD5) from the State Licensing Authority. Importers must obtain an import license (MD15) from the Central Licensing Authority.
Risk Classification and License Requirements
- Device: Pneumatic Tourniquet & attachments (console unit and cuffs)
- Risk Class: A (Low risk)
- Intended Use: To compress arteries and stop blood flow during surgeries
- Category: General Hospital or Orthopaedic Instruments
- License Type: MD5 Manufacturing License (Form MD3)
Class A devices require a manufacturing license issued by the State Authority. The process involves obtaining a Test License (MD13), product testing, audit by a notified body, and final license issuance.
Manufacturing License Process (MD5)
The MD5 licensing process consists of several stages:
Apply for Test License (Form MD13): This initial license permits manufacturing for testing. It typically takes 1.5 to 2 months to obtain.
Product Testing: The Pneumatic Tourniquet and attachments must be tested in government-approved laboratories. Testing covers safety, performance, and compliance with Indian standards. Refer to the list of testing laboratories.
Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Apply for Manufacturing License (Form MD3): Submit the application on the CDSCO MD Online Portal along with required documents.
Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing facility. Check the list of notified bodies approved for MD5 audits.
Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
License Grant (Form MD5): Upon satisfactory completion, the State Authority grants the manufacturing license.
Manufacturing License Documents Required
For Pneumatic Tourniquet Class A devices, you need to prepare and submit the following:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification Documents
- Fire NOC and Pollution Control Certificate
- Device Master File (Detailed design, specs, and manufacturing processes) — see our Device Master File guide
- Plant Master File (Facility layout, equipment, quality controls) — detailed in our Plant Master File guide
- Essential Principles Checklist confirming compliance with Indian standards
- Risk Management File demonstrating risk analysis and mitigation
- Product Test Reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485:2016 recommended)
Import License Process (MD15) for Pneumatic Tourniquet
If you are an importer of Pneumatic Tourniquets, the MD15 license is mandatory. This license is granted by the Central Licensing Authority and takes approximately 5-6 months.
Key steps:
Prepare all required documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, Device and Plant Master Files, Wholesale License, and Company Constitution.
Submit the application on the CDSCO MD Online Portal using Form MD14.
Resolve any queries raised by CDSCO promptly.
Receive the import license (Form MD15).
Import License Documents Required
- Valid Manufacturing License of the device from the country of origin
- Free Sale Certificate issued by the regulatory authority of the exporting country
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Manufacturing License (MD5) | 1.5 – 2 months |
| Total Time for MD5 License | Approx. 3 – 4 months |
| Import License (MD15) | 5 – 6 months |
Government Fees and Costs
For Pneumatic Tourniquet (Class A) manufacturing license (MD5):
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
For import license (MD15), fees vary by class; for Class A devices, approximately USD 1,000 per site and USD 50 per product.
Common Challenges and Solutions
Delays in Test License Issuance: Ensure all documents are meticulously prepared before submission. Incomplete forms lead to back-and-forth delays.
Product Testing Failures: Select accredited testing laboratories experienced with orthopedic instruments to prevent repeated tests.
Audit Non-compliance: Conduct internal audits and mock inspections prior to notified body visits to identify gaps.
Documentation Gaps: Use comprehensive templates for Device and Plant Master Files; our guides can help streamline this process.
Query Resolution Lag: Designate a dedicated regulatory liaison to respond swiftly and clearly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing for Pneumatic Tourniquets requires precision and experience. Our consultancy has successfully guided over 500 manufacturers and importers through test licenses, audits, and final approvals.
We offer:
- End-to-end application preparation and submission
- Tailored audit readiness programs
- Device Master File and Plant Master File documentation support
- Regulatory updates and compliance monitoring
Getting Started with Your CDSCO License Application
Evaluate your device classification: Confirm your Pneumatic Tourniquet falls under Class A as per the latest CDSCO notifications.
Prepare for Test License Application (MD13): Gather all required documents and submit your application via the CDSCO MD Online Portal.
Plan product testing: Engage with government-approved labs early to schedule tests.
Compile comprehensive documentation: Utilize our Device Master File and Plant Master File guides.
Select a notified body for audit: Review the list of notified bodies and initiate audit planning.
Submit MD5 license application: Complete and upload Form MD3 on the CDSCO portal.
Maintain proactive communication: Respond quickly to CDSCO and notified body queries to avoid delays.
Embarking on this regulatory journey with expert guidance maximizes your chances of timely approval and market entry. Reach out to us to leverage our deep expertise and ensure your Pneumatic Tourniquet and its attachments are fully compliant with Indian regulatory standards.
