CDSCO License for Airway tube forceps

Comprehensive Guide to CDSCO Licensing for Airway Tube Forceps (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in navigating the Indian medical device regulatory landscape, we understand the critical importance of obtaining the correct CDSCO license for your medical device. In this guide, we focus on the Airway Tube Forceps, a Class A anesthesiology device, detailing the regulatory framework, licensing process, timelines, costs, and practical advice to help manufacturers and importers successfully enter the Indian market.

Understanding the Airway Tube Forceps and Its Regulatory Importance

The Airway Tube Forceps is a hand-held instrument designed to grasp tubes for insertion or extraction into/from the airways or to remove obstructive objects. Categorized under anesthesiology devices, it is classified as a low-risk (Class A) medical device under the CDSCO framework, per Notification 29/Misc/03/2020-DC(177) dated 12.07.2021.

Despite its low-risk classification, compliance with CDSCO regulations is mandatory for manufacturing or importing this device into India. Proper licensing ensures patient safety, regulatory adherence, and seamless market access.

CDSCO Regulatory Framework for Class A Medical Devices like Airway Tube Forceps

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Devices are classified into Classes A, B, C, and D based on risk. Class A devices, including Airway Tube Forceps, require a manufacturing license (MD5) issued by the State Licensing Authority.

The regulatory process involves initial test licensing, product testing in government-approved labs, documentation, audit by notified bodies, and final license issuance.

Risk Classification and License Requirements for Airway Tube Forceps

• Risk Class: A (Low Risk)
• License Type: MD5 (Manufacturing License for Class A & B devices)
• Application Form: MD3
• Authority: State Licensing Authority
• Process Duration: Approx. 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

For detailed understanding of medical device classification, manufacturers can refer to the Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Airway Tube Forceps

1. Apply for Test License (Form MD13): Before the manufacturing license, you must obtain a test license valid for 1 year, allowing you to manufacture the device for testing purposes. This step typically takes 1.5-2 months.

2. Product Testing: Get your Airway Tube Forceps tested at CDSCO-approved government laboratories. The list of such Testing Laboratories is available online. Testing ensures conformity to essential principles.

3. Prepare Documentation: Compile all necessary documents including Device Master File, Plant Master File, risk management, labels, Instructions for Use (IFU), and Quality Management System (QMS) documents.

4. Application Submission: Submit your MD5 application on the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: A notified body conducts an audit of your manufacturing premises and QMS. You can check the list of notified bodies authorized for MD5 audits.

6. Queries and Clarifications: Respond promptly to any queries raised by the licensing authority or notified body.

7. License Grant: Upon successful audit and query resolution, the State Licensing Authority issues the MD5 license (Form MD5).

For an in-depth look at the MD5 license process, our MD5 License Guide provides extensive insights.

Essential Documents Required for MD5 License Application

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing information. Our Device Master File guide can help you prepare this document.
• Plant Master File (PMF): Details about your manufacturing facility. See our Plant Master File guide for preparation tips.
• Essential Principles Checklist
• Risk Management File
• Product Test Reports from Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 recommended)

Import License Process (MD15) for Airway Tube Forceps

If you plan to import Airway Tube Forceps into India, you must obtain an Import License (MD15) from the Central Licensing Authority.

• Application Form: MD14
• Authority: CDSCO Central Licensing Authority
• Processing Time: Approximately 5-6 months
• Fees: Rs 1000 per site + Rs 50 per product for Class A

Unlike manufacturing, no test license is required. Documentation includes your manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.

Apply through the same CDSCO MD Online Portal and be prepared for thorough scrutiny.

For a detailed walkthrough of the import license process, refer to our Import License Guide.

Timeline and Processing Duration

Manufacturers should plan accordingly, considering potential delays during audit scheduling or query responses.

Government Fees and Costs

• MD5 License Application: Rs 5,000 (one-time per application)
• Product Fee: Rs 500 per product
• Test License (MD13): Usually included in application fees but confirm during submission
• Audit Fees: Paid directly to Notified Body as per their schedule

For import licenses (MD15), fees differ and are higher, reflecting central authority processing.

Common Challenges and Practical Solutions

• Delay in Test Lab Reports: Government labs can have backlogs. We recommend initiating testing early and considering private labs accredited by CDSCO.

• Incomplete Documentation: Ensure all files, especially DMF and PMF, are complete and compliant. Use our guides to avoid common pitfalls.

• Audit Scheduling Conflicts: Book your audit slots well in advance and maintain open communication with the notified body.

• Query Mismanagement: Respond promptly and comprehensively to avoid license delays.

• Technical Staff Qualification Gaps: Hire or train qualified personnel ahead of application.

Expert Consultation and Support

With over 25 years in medical device regulatory consulting and having helped over 500 companies, we provide tailored support for every step—from documentation preparation, audit readiness, to query resolution.

Our expertise simplifies the complexities of CDSCO licensing, mitigates risks of rejection, and accelerates your time to market.

Getting Started with Your CDSCO License Application for Airway Tube Forceps

1. Evaluate your manufacturing premises and technical staff qualifications.
2. Prepare your Device Master File and Plant Master File using our comprehensive guides.
3. Apply for the Test License (Form MD13) on the CDSCO MD Online Portal.
4. Schedule product testing at approved laboratories early.
5. Compile all required documents meticulously before submitting your MD5 application (Form MD3).
6. Engage with a notified body for the mandatory audit and prepare your team accordingly.
7. Maintain proactive communication for query resolution.

By following these actionable steps and leveraging our seasoned guidance, manufacturers and importers can confidently navigate the CDSCO licensing process for Airway Tube Forceps, ensuring compliance and a successful launch in the Indian market.

For personalized support or clarification, feel free to reach out to our regulatory consulting team to streamline your licensing journey.