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CDSCO License for Medical gas pipeline system pressure monitor

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).

Device Class
Class A

Intended Use

A component of a medical gas pipeline system designed to continuously monitor and detect changes in the pressure values of the medical gases in the supply  pipeline.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Medical gas pipeline system pressure monitor

Introduction to Medical Gas Pipeline System Pressure Monitor and Regulatory Importance

Medical gas pipeline system pressure monitors are critical components in anesthesiology, designed to continuously monitor and detect changes in the pressure values of medical gases within the supply pipeline. Accurate pressure monitoring ensures patient safety by preventing gas supply failures or pressure anomalies during critical procedures.

Given their vital role, these devices fall under Class A (low risk) as per CDSCO classification, requiring strict adherence to regulatory standards to ensure quality and safety. Navigating the CDSCO licensing process is essential for manufacturers aiming to market this device in India.

CDSCO Regulatory Framework for Medical Gas Pipeline System Pressure Monitor

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The medical gas pipeline system pressure monitor is notified under the category of Anesthesiology devices, specifically classified as Class A according to Notification 29/Misc/03/2020-DC(177) dated 12.07.2021.

As a Class A device, the regulatory oversight is managed primarily at the state level through the issuance of an MD5 manufacturing license. This ensures compliance with essential principles of safety, efficacy, and quality.

Risk Classification and License Requirements

Under the CDSCO classification system, medical gas pipeline system pressure monitors fall under Class A (low risk). The risk classification impacts the licensing authority, documentation, and audit process:

  • Class A Devices: MD5 License (Application Form MD3), issued by State Licensing Authority.
  • Test License: Required on Form MD13 before the MD5 application.
  • Audit: Conducted by notified bodies approved by CDSCO.

Understanding this classification is crucial for correct application submission and adherence to timelines.

Manufacturing License Process (MD5 License) for Medical Gas Pipeline System Pressure Monitor

The MD5 manufacturing license process for Class A devices includes the following sequential steps:

  1. Apply for Test License (Form MD13): This initial step permits product testing in government-approved laboratories.
  2. Product Testing: Samples are tested to verify compliance with Indian standards.
  3. Document Preparation: Compile required technical and quality documents.
  4. Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
  5. Notified Body Audit: An audit of manufacturing premises and QMS is conducted by a notified body from the CDSCO Notified Bodies List.
  6. Resolution of Queries: Address any deficiencies or queries raised by the licensing authority or notified body.
  7. Grant of License (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

Manufacturing License Documents Required for MD5

Accurate and comprehensive documentation expedites approval. The following are mandatory:

  • Company Constitution: Certificate of incorporation or partnership deed.
  • Proof of Premises Ownership/Lease: Valid property documents.
  • Technical Staff Credentials: Qualification certificates and experience proof.
  • Fire NOC: Fire safety clearance from local authorities.
  • Pollution Control Board NOC: Environmental clearance.
  • Device Master File (DMF): Detailed design and manufacturing processes. Our Device Master File guide offers in-depth insights.
  • Plant Master File (PMF): Manufacturing environment and facilities documentation. Refer to our Plant Master File guide for best practices.
  • Essential Principles Checklist: Compliance with safety and performance standards.
  • Risk Management File: Documented risk analysis and mitigation strategies as per risk management guidelines.
  • Test Reports: From CDSCO-approved testing laboratories such as those listed here.
  • Labels and Instructions for Use (IFU): Accurate and compliant labeling.
  • Quality Management System (QMS) Documents: ISO 13485 certification and related processes.

Import License Process (MD15) for Medical Gas Pipeline System Pressure Monitor

While the focus here is on manufacturing, importers must obtain the MD15 import license from the Central Licensing Authority. This process is more extensive, typically taking 5-6 months, and requires documents such as manufacturing license, free sale certificate, ISO and CE certifications, and other technical files.

For detailed guidance, refer to our Import License guide.

Import License Documents Required

  • Valid Manufacturing License (MD5/MD9) from the country of origin.
  • Free Sale Certificate: Issued by the competent authority.
  • ISO 13485:2016 Certification.
  • CE Certificate: If applicable.
  • Device Master File and Plant Master File.
  • Wholesale License: From the importer in India.
  • Company Constitution Documents.

Timeline and Processing Duration for MD5 License

From our extensive experience managing over 500 CDSCO license applications, here is a realistic timeline for the MD5 license:

  • Test License (MD13) Application and Grant: Approximately 1.5 to 2 months.
  • Product Testing in Government-Approved Lab: 3 to 4 weeks.
  • Document Compilation and Preparation: 2 to 3 weeks.
  • MD5 Application Submission and Notified Body Audit: 1 to 1.5 months.
  • Query Resolution and Final Approval: 2 to 4 weeks.

Total estimated duration: 3 to 4 months.

Planning accordingly and maintaining proactive communication with the licensing authority can prevent delays.

Government Fees and Costs

Fees for MD5 licenses are structured as follows:

  • Application Fee: Rs. 5,000 per application.
  • Product Fee: Rs. 500 per product.

In addition to government fees, manufacturers should budget for:

  • Testing laboratory charges.
  • Notified body audit fees.
  • Document preparation and consultancy support, if required.

Compared to Class C/D licenses, MD5 is cost-effective but demands meticulous compliance.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Early sample submission to CDSCO-approved labs and monitoring progress regularly can mitigate this.

Challenge 2: Incomplete Documentation

Solution: Utilize comprehensive checklists and expert consultation to ensure all documents align with regulatory expectations.

Challenge 3: Audit Non-Conformities

Solution: Conduct pre-audit internal reviews and train staff on compliance requirements to minimize findings.

Challenge 4: Query Resolution Delays

Solution: Prepare detailed and prompt responses to queries, supported by evidence and documentation.

Expert Consultation and Support

With over 25 years of experience assisting more than 500 companies, we specialize in streamlining CDSCO licensing for medical gas pipeline system pressure monitors and similar Class A devices. Our services include:

  • Gap analysis and document preparation.
  • Coordination with testing labs and notified bodies.
  • Application filing and tracking via the CDSCO MD Online Portal.
  • Query response management and audit support.

Our proven approach minimizes approval time and maximizes compliance confidence.

Getting Started with Your CDSCO License Application

  1. Assess Device Classification: Confirm your device is Class A under CDSCO rules, which applies to medical gas pipeline system pressure monitors.
  2. Initiate Test License Application: Submit Form MD13 through the CDSCO MD Online Portal to begin product testing.
  3. Engage with Testing Laboratories: Choose from government-approved labs for product evaluation.
  4. Prepare Comprehensive Documentation: Refer to our Device Master File and Plant Master File guides to compile robust dossiers.
  5. Plan for Notified Body Audit: Select an appropriate notified body from the official list early to schedule audits timely.
  6. Submit MD5 Application: Once testing and documentation are complete, apply using Form MD3 online.
  7. Prepare for Audit and Queries: Anticipate and promptly address any observations.

By following these practical steps and leveraging expert support, manufacturers can confidently navigate the CDSCO licensing process and bring medical gas pipeline system pressure monitors to the Indian market efficiently.

For personalized consultation and end-to-end regulatory support, contact us to leverage our decades of expertise in medical device licensing.

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About the Author

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Tails Azimuth
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