CDSCO License for Laryngeal airway introducer
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
A device intended to aid insertion of a laryngeal airway into the pharyngeal cavity of a patient while reducing or eliminating the need for finger manipulation within the mouth. It is typically in the form of a metal blade with a handle and may be mounted onto the laryngeal airway during insertion. This is a reusable device intended to be sterilized prior to use.
Introduction to Laryngeal Airway Introducer and Its Regulatory Importance
The laryngeal airway introducer is a critical device in anesthesiology, designed to facilitate the insertion of a laryngeal airway into the pharyngeal cavity while minimizing finger manipulation inside the patient mouth. Typically constructed as a metal blade with a handle, this reusable device must be sterilized before each use to ensure patient safety. Given its direct interaction with the airway and reusable nature, regulatory compliance is paramount to ensure quality, safety, and efficacy.
Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to market the laryngeal airway introducer in India. With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide you with an expert roadmap tailored specifically for this Class A medical device.
CDSCO Regulatory Framework for Laryngeal Airway Introducer
The CDSCO governs the import, manufacturing, and sale of medical devices in India under the Medical Device Rules, 2017. The laryngeal airway introducer falls under the anesthesiology category and is classified as a Class A device, based on the Notification 29/Misc/03/2020-DC(177) dated 12.07.2021.
As a Class A device, it is subject to the least regulatory burden but still requires a manufacturing license (MD5) issued by the State Licensing Authority. The rules emphasize robust quality management systems, product testing, and compliance with essential principles to ensure patient safety.
Risk Classification and License Requirements for Class A Devices
Class A devices are considered low risk. For the laryngeal airway introducer, this classification means:
- License type: MD5 Manufacturing License (Application Form MD3)
- Licensing authority: State Licensing Authority
- Process duration: Approximately 3 to 4 months
- Fees: Rs 5,000 per application + Rs 500 per product
The MD5 license ensures that the manufacturing facility complies with Good Manufacturing Practices (GMP) and that the product meets the necessary quality standards.
Manufacturing License Process for Laryngeal Airway Introducer (MD5 License)
The manufacturing license process for Class A devices involves multiple sequential steps:
Test License (Form MD13): Before applying for the manufacturing license, the manufacturer must obtain a test license, which takes about 1.5 to 2 months. This license allows for sample production and testing.
Product Testing: The device must be tested at CDSCO-approved laboratories to verify compliance with relevant standards. Refer to the list of testing laboratories for accredited facilities.
Documentation Preparation: Prepare essential documents such as Device Master File (DMF), Plant Master File (PMF), risk management file, and quality management system (QMS) documentation.
Application Submission: Submit the MD5 application (Form MD3) through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a CDSCO-notified body is conducted to inspect the manufacturing site and verify compliance. You can check the list of notified bodies authorized for audits.
Resolution of Queries: Address any queries or observations raised during the audit or by CDSCO officials promptly.
Grant of License: Upon satisfactory completion, the license is granted on Form MD5.
Manufacturing License Documents Required for Laryngeal Airway Introducer
The documentation requirements are comprehensive and critical for a smooth licensing process:
- Company Constitution: Incorporation certificate, partnership deed, or other relevant legal documents.
- Proof of Ownership or Lease of Manufacturing Premises: Documents establishing legal possession of the manufacturing site.
- Technical Staff Credentials: Details and qualifications of technical personnel involved in manufacturing.
- Fire NOC and Pollution Control NOC: Certificates from appropriate authorities ensuring safety compliance.
- Device Master File (DMF): Detailed description of the device design, manufacturing process, and validation. Our Device Master File guide elaborates these requirements.
- Plant Master File (PMF): Information about the manufacturing facility, quality control procedures, and equipment. Visit our Plant Master File guide for detailed insights.
- Essential Principles Checklist: A declaration confirming compliance with essential principles of safety and performance.
- Risk Management File: Documentation of risk analysis and mitigation strategies relevant to the device. Our Risk Management resource can assist you.
- Test Reports: Laboratory testing results confirming product safety and performance.
- Labels and Instructions for Use (IFU): Samples reflecting regulatory compliance.
- Quality Management System (QMS) Documents: ISO 13485 certification and quality manuals.
Import License Process for Laryngeal Airway Introducer (MD15 License)
If you are an importer rather than a manufacturer, the applicable license is the MD15 license, granted by the Central Licensing Authority. The process is as follows:
- Application: Submit Form MD14 via the CDSCO MD Online Portal.
- Documentation: Prepare and upload necessary documents (detailed in the next section).
- Queries Resolution: Respond promptly to any departmental queries.
- License Grant: Typically granted within 5 to 6 months.
Notably, importers do not require a test license but must ensure compliance with all import regulations and quality standards.
Import License Documents Required
The import license application demands the following documents:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale license
- Company Constitution
Fees vary based on risk classification; for Class A devices, the fee is approximately 50 per product.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| Application Processing | 1 to 2 weeks |
| Audit by Notified Body | 1 to 1.5 months |
| Query Resolution | 2 to 4 weeks |
| Total for MD5 License | 3 to 4 months |
For import licenses (MD15), the process takes approximately 5 to 6 months.
Government Fees and Costs
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Typically included in the application fees but may have nominal charges
Additional costs include product testing fees at government-approved labs, audit fees charged by notified bodies, and internal costs related to document preparation and quality system implementation.
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or inconsistent documents are the primary cause of delays. We recommend conducting a thorough internal audit using our checklists before submission.
Delayed Product Testing: Schedule testing early with CDSCO-approved labs to avoid bottlenecks.
Audit Non-Compliance: Engage experienced consultants to pre-assess your facility against notified body requirements.
Query Management: Maintain a dedicated team for prompt and precise responses to CDSCO queries.
Understanding Classification: Misclassification can lead to inappropriate licensing applications. Use reliable resources like the Medical Device Classification guide to confirm.
Expert Consultation and Support
With our extensive experience assisting over 500 companies in CDSCO licensing, we offer tailored consulting services including:
- Gap analysis for documentation and QMS
- Coordination with notified bodies and testing labs
- Complete application preparation and submission
- Post-licensing support and compliance monitoring
Our expertise ensures streamlined licensing with minimal rejections or delays.
Getting Started with Your CDSCO License Application
Evaluate Your Classification: Confirm that the laryngeal airway introducer is indeed Class A per the latest CDSCO notifications.
Prepare Your Documents: Begin assembling your Device Master File, Plant Master File, risk management file, and other critical documents.
Apply for Test License: Submit Form MD13 to initiate the testing phase via the CDSCO MD Online Portal.
Engage Testing Laboratory: Coordinate with a CDSCO-approved lab early to schedule testing and avoid delays.
Plan for Audit: Identify and connect with a notified body from the official list to schedule your manufacturing site audit.
Submit Manufacturing License Application: Once tests and documentation are ready, submit Form MD3 on the MD Online portal.
Prepare for Follow-up: Establish a team to handle queries and audit observations efficiently.
Embarking on the CDSCO licensing journey for your laryngeal airway introducer can be complex, but with the right guidance and preparation, you can achieve compliance and market access swiftly. Contact us today to leverage our proven expertise and ensure your manufacturing or import operations meet all regulatory expectations.
For more detailed insights, explore our MD5 License Guide and comprehensive support services tailored to Class A medical devices.
