CDSCO License for Electronically operated Tourniquet Single & Double Cuff Consol

Comprehensive Guide to CDSCO Licensing for Electronically Operated Tourniquet Single & Double Cuff Consol

As a trusted regulatory consulting firm with over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the nuances and critical requirements for obtaining approval for devices like the Electronically Operated Tourniquet Single & Double Cuff Consol. This device, classified as Class B under the General Hospital or Orthopaedic Instruments category, demands careful adherence to regulatory standards to ensure timely market access in India.

Understanding the Device and Regulatory Importance

The Electronically Operated Tourniquet is designed to stop blood flow through arteries by compression, a critical function during surgeries requiring bloodless fields. Given its direct impact on patient safety and clinical outcomes, the Central Drugs Standard Control Organization (CDSCO) mandates a stringent licensing process ensuring compliance with Indian medical device regulations.

CDSCO Regulatory Framework for Electronically Operated Tourniquets

Following the Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, electronically operated tourniquets fall under Class B devices. These are moderate risk devices governed by the Medical Devices Rules, 2017, where the manufacturing license is issued by the State Licensing Authority via the MD5 license route.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• License Type: MD5 License (Form MD3 for application, Form MD5 for grant)
• Regulatory Authority: State Licensing Authority

Class B devices require compliance with quality and safety standards, including audits by notified bodies and product testing at CDSCO-recognized labs.

Manufacturing License Process (MD5 License)

For manufacturers intending to produce Electronically Operated Tourniquet Consols, the MD5 license process involves several clearly defined steps:

1. Apply for Test License (Form MD13): Before the manufacturing license, a test license is necessary, typically taking 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved laboratories to validate safety and efficacy.
3. Document Preparation: Compile technical documentation including Device Master File, Plant Master File, Risk Management Files, and QMS documents.
4. Application Submission: Submit the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body audit is conducted to verify compliance. Refer to the list of notified bodies for suitable auditors.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon successful evaluation, the MD5 license is granted (Form MD5).

Manufacturing License Documents Required

Prepare the following essential documents to streamline your application:

• Company constitution or incorporation certificate
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical personnel
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device description, design, manufacturing process, and performance data (learn more)
• Plant Master File (PMF): Overview of manufacturing facilities and quality systems (guide here)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating risk analysis and mitigation (risk management insights)
• Test reports from CDSCO-recognized labs (testing labs list)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15 License)

If you are an importer seeking to bring the Electronically Operated Tourniquet into India, the MD15 import license under the Central Licensing Authority applies. The process, generally spanning 5 to 6 months, involves:

• Document preparation including manufacturer’s MD5/MD9 license, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device and Plant Master Files
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Query resolution with the authorities
• License grant on Form MD15

Government fees vary based on device class as detailed later.

Import License Documents Required

• Valid manufacturing license (MD5 for Class B) of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE certificate or equivalent quality assurance
• Device Master File and Plant Master File
• Wholesale license of importer
• Company constitution documents

Timeline and Processing Duration

Timely submission of complete documentation and prompt responses to queries can significantly reduce processing delays.

Government Fees and Costs

For the Electronically Operated Tourniquet (Class B):

• MD5 License:
  • Application fee: ₹5,000
  • Per product fee: ₹500
• MD15 Import License:
  • Site fee: $2,000 USD
  • Per product fee: $1,000 USD

Additional costs include notified body audit fees and testing laboratory charges, which vary based on scope and complexity.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation

Solution: Engage early with experienced regulatory consultants to ensure document readiness, including Device Master File and Risk Management documents.

Challenge: Difficulty in identifying an appropriate notified body

Solution: Utilize the official list of notified bodies and select those with relevant expertise in Class B devices.

Challenge: Extended testing timelines

Solution: Plan product testing well in advance with CDSCO-approved laboratories and maintain close communication to avoid bottlenecks.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for devices like electronically operated tourniquets that involve both mechanical and electronic components. Our team offers:

• Customized gap analysis of your current documentation
• End-to-end assistance with test license applications
• Coordination with notified bodies and labs
• Training sessions on regulatory compliance and QMS implementation

Our proven track record with over 500 successful CDSCO license projects ensures your application progresses smoothly.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm the applicable license (MD5 for Class B). You can verify classifications on platforms like Medical Device Classification.
2. Prepare your Device Master File and Plant Master File thoroughly, focusing on device design and manufacturing controls. Our DMF guide is a valuable resource.
3. Apply for your test license (Form MD13) via the CDSCO MD Online Portal.
4. Schedule product testing at a CDSCO-approved laboratory.
5. Compile all required documents, including risk management and essential principles checklist.
6. Submit your manufacturing license application (Form MD3) online and prepare for the notified body audit.
7. Respond promptly to any authority queries to avoid delays.

Embarking on this structured pathway with expert support will position your Electronically Operated Tourniquet for successful licensing and market entry in India. Contact us today to initiate your licensing journey with confidence.