CDSCO License for Anaesthesia instrument table
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
It is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures.
Comprehensive Guide to CDSCO Licensing for Anaesthesia Instrument Tables (Class A Medical Device)
As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided 500+ manufacturers and importers through the complex CDSCO licensing process in India. This detailed guide focuses on the Anaesthesia Instrument Table—a Class A medical device intended to support anesthesia instruments during general anesthesia surgical procedures under the anesthesiology category (Notification 29/Misc/03/2020-DC(177), dated 12.07.2021).
Understanding the Regulatory Importance of Anaesthesia Instrument Tables
Anaesthesia Instrument Tables play a critical role in surgical environments by securely supporting anesthesia devices. Despite being a Class A device with the lowest risk classification, adherence to India's stringent regulatory requirements is mandatory to ensure patient safety and market access. Proper licensing from CDSCO (Central Drugs Standard Control Organization) is essential before manufacturing or importing these tables in India.
CDSCO Regulatory Framework for Anaesthesia Instrument Tables
Under the Medical Device Rules 2017, the Indian regulatory framework classifies medical devices into four risk classes—A, B, C, and D. Anaesthesia Instrument Tables fall under Class A due to their intended use and risk profile. Regulatory oversight for Class A devices is managed by the State Licensing Authority (SLA) through the issuance of an MD5 manufacturing license.
Risk Classification and License Requirements
- Device: Anaesthesia Instrument Table
- Risk Class: A (Low risk)
- Regulatory Authority: State Licensing Authority
- License Type: MD5 Manufacturing License (Form MD3)
Class A devices require less stringent controls compared to higher-risk classes but still demand comprehensive documentation, testing, and compliance with essential principles to ensure safety and efficacy.
Manufacturing License Process (MD5) for Anaesthesia Instrument Tables
The MD5 license process involves multiple critical steps:
Test License Acquisition (Form MD13): Before manufacturing, obtain a test license, which typically takes 1.5 to 2 months. This allows limited production for testing purposes.
Product Testing: Submit samples to CDSCO-approved government laboratories for mandatory testing. Refer to the Testing Laboratories list for approved facilities.
Documentation Preparation: Compile the required documents, including Device Master File and Plant Master File.
Application Submission: Apply for the MD5 license using Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: Engage a notified body for an on-site audit. Check the Notified Bodies list for authorized auditors.
Query Resolution: Respond promptly to any queries raised by CDSCO or the notified body.
License Grant: Upon successful completion, the MD5 license (Form MD5) is issued by the State Licensing Authority.
Manufacturing License Documents Required
For Anaesthesia Instrument Tables, the following documents must be meticulously prepared:
- Company Constitution (e.g., Memorandum of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Comprehensive documentation covering design, specifications, and manufacturing processes. Our detailed Device Master File guide can help streamline preparation.
- Plant Master File (PMF): Information on manufacturing facilities and quality control systems. Refer to our Plant Master File guide for best practices.
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File demonstrating hazard analysis and mitigation strategies
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents (ISO 13485 certification is highly recommended)
Import License Process (MD15) for Anaesthesia Instrument Tables
Although this guide primarily focuses on manufacturing, importers must apply for the MD15 import license (Form MD14) via the CDSCO MD Online Portal. This process generally takes 5-6 months and requires:
- Valid Manufacturing License (MD5/MD9) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Government fees vary by device class; Class A devices incur lower fees compared to higher-risk categories. Learn more from our Import License guide.
Timeline and Processing Duration
| License Type | Timeline | Key Activities |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Limited manufacturing authorization for testing |
| Product Testing | 1 – 1.5 months | Government lab testing of samples |
| MD5 License (MD3) | 1.5 – 2 months | Document submission, audit by notified body, query resolution, license issuance |
Total estimated duration: 3 to 4 months from start to finish.
Government Fees and Costs
- Test License (MD13): Nominal fee as prescribed by the authority
- MD5 License Application: Rs. 5,000 per application plus Rs. 500 per product
- Testing Fees: Varies depending on the government laboratory and number of tests
- Audit Fees: Payable to the notified body conducting the audit
Budgeting for these costs upfront ensures smooth application processing.
Common Challenges and Practical Solutions
Challenge 1: Incomplete Documentation
- Solution: Use standardized templates for DMF and PMF. Our guides can help ensure completeness.
Challenge 2: Delayed Testing Results
- Solution: Schedule sample submissions early and follow up with testing labs proactively.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal pre-audit checks and ensure staff training on regulatory compliance.
Challenge 4: Query Resolution Delays
- Solution: Respond promptly and provide clear, evidence-backed replies to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape can be daunting, especially for first-time manufacturers or importers. With our extensive experience, we offer tailored consulting services—from documentation support to audit readiness and application submission—ensuring your Anaesthesia Instrument Table gains timely approval.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm the classification as Class A using resources like our Medical Device Classification guide.
Prepare Documentation: Begin compiling your Device Master File and Plant Master File with expert assistance.
Obtain Test License: Apply for the MD13 test license via the CDSCO MD Online Portal.
Coordinate Product Testing: Arrange sample testing at approved laboratories early in the process.
Plan for Audit: Select a notified body for the mandatory audit and schedule it timely.
Submit MD5 License Application: Once testing and audit are complete, apply for the MD5 license online.
Starting early and maintaining clear communication with regulatory authorities can significantly reduce approval timelines.
For personalized assistance and to ensure your Anaesthesia Instrument Table complies seamlessly with CDSCO regulations, contact our expert team today and leverage our proven track record in medical device licensing across India.
