CDSCO License for Artificial airway stylet

Comprehensive Guide to CDSCO Licensing for Artificial Airway Stylet (Class A Medical Device)

Artificial airway stylets, classified as Class A medical devices under India's CDSCO regulations, play a crucial role in anesthesiology by stiffening or maintaining the shape of artificial airway tubes to facilitate intubation. Given its critical application, regulatory compliance is essential for manufacturers and importers to enter the Indian market legally and effectively. With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide a detailed roadmap tailored specifically for the artificial airway stylet.

CDSCO Regulatory Framework for Artificial Airway Stylet

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. The artificial airway stylet falls under the anesthesiology category and is notified under reference 29/Misc/03/2020-DC(177) dated 12.07.2021. As a Class A device, it is subject to the least stringent regulatory controls but still requires a manufacturing license (MD5) from the State Licensing Authority before commercial distribution.

Risk Classification and License Requirements

Class A devices are considered low-risk and are regulated under the MD5 license scheme. This involves:

Obtaining a Test License (Form MD13) initially
Product testing at CDSCO-approved laboratories
Submission of the MD5 license application (Form MD3)
Audit by a notified body

For your artificial airway stylet, this process ensures compliance with safety and performance standards without unnecessary delays.

Manufacturing License Process (MD5) for Artificial Airway Stylet

The MD5 license process for your device includes the following critical steps:

Apply for Test License (Form MD13): This preliminary license allows you to manufacture devices for testing purposes. Processing time is approximately 1.5 to 2 months.
Product Testing: Get your artificial airway stylet tested at a government-approved lab. Refer to the list of testing laboratories to select an authorized facility.
Documentation Preparation: Compile detailed technical and quality documentation.
Submit MD5 Application (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An inspection is conducted by an accredited entity. You can check the list of notified bodies authorized for MD5 audits.
Query Resolution: Address any queries from the department or notified body promptly.
Grant of MD5 License: Upon satisfactory compliance, the license is granted on Form MD5.

Manufacturing License Documents Required for Artificial Airway Stylet

To ensure a smooth approval process, prepare the following key documents:

Company Constitution Documents: Certificate of incorporation, partnership deed, or equivalent
Proof of Premises Ownership or Lease Agreement: Valid address proof of manufacturing site
Technical Staff Qualification and Experience Certificates: Details of production and quality control personnel
Fire NOC and Pollution Control NOC: Compliance certificates from local authorities
Device Master File (DMF): Detailed device specifications, design, and manufacturing processes (see our comprehensive Device Master File guide)
Plant Master File (PMF): Description of manufacturing facilities and quality management systems (refer to our Plant Master File guide)
Essential Principles Checklist: Demonstrating conformity with CDSCO requirements
Risk Management File: Documentation of risk analysis and mitigation strategies (learn more about risk management)
Test Reports: From CDSCO-approved labs confirming device safety and efficacy
Labels and Instructions for Use (IFU): Sample labels and user manuals compliant with CDSCO guidelines
Quality Management System (QMS) Documents: ISO 13485 certification and internal audit reports

Ensuring these documents are thorough and accurate can significantly reduce processing delays.

Import License Process (MD15) for Artificial Airway Stylet

While your device is Class A and primarily requires an MD5 manufacturing license for domestic production, importers must secure an MD15 import license. The process includes:

Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if available, and relevant master files
Application Submission: File Form MD14 via the CDSCO MD Online Portal
Query Resolution and License Grant: The process typically takes 5-6 months

For detailed guidance, consult our Import License Guide.

Import License Documents Required

Key documents include:

Valid manufacturing license from the originating country
Free Sale Certificate
ISO 13485:2016 certificate
CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale license
Company Constitution documents

Timeline and Processing Duration

The entire MD5 licensing process for your artificial airway stylet generally spans 3 to 4 months, broken down as follows:

Test license application and approval: 1.5 to 2 months
Product testing: 3 to 4 weeks (dependent on lab backlog)
Preparation and submission of MD5 application: 2 to 3 weeks
Notified body audit and query resolution: 3 to 4 weeks

Being proactive in document preparation and addressing queries promptly can help avoid unnecessary delays.

Government Fees and Costs

For Class A devices like the artificial airway stylet, the fee structure is:

Application fee: Rs 5,000 per application
Product fee: Rs 500 per product

These fees are payable through the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

Challenge 1: Delayed product testing due to lab backlogs

Solution: Schedule testing well in advance and select labs with shorter waiting times from the CDSCO-approved testing labs list.

Challenge 2: Incomplete or inconsistent documentation

Solution: Use standardized templates for Device Master Files and Plant Master Files. Leverage our expert guides to ensure completeness.

Challenge 3: Audit non-compliance

Solution: Conduct internal audits and gap analyses before notified body inspections. Prepare your QMS and technical staff accordingly.

Challenge 4: Slow query response times

Solution: Assign a dedicated regulatory liaison to monitor and respond to CDSCO communications promptly.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex, especially for first-time applicants. Our team, having facilitated over 500 successful licenses, offers end-to-end support:

Pre-application gap analysis
Document preparation and review
Coordination with notified bodies and testing labs
Audit readiness training
Post-license compliance consulting

Engage with experienced consultants to streamline your regulatory pathway and minimize risks.

Getting Started with Your CDSCO License Application for Artificial Airway Stylet

To initiate your MD5 license application:

Register your company and manufacturing site details on the CDSCO MD Online Portal.
Prepare and submit the Test License application (Form MD13) along with essential documents.
Plan and book testing slots with approved laboratories.
Simultaneously, begin compiling your Device Master File and Plant Master File using our detailed guides.
Once test reports are received, submit the MD5 application (Form MD3).
Prepare for the notified body audit by reviewing your QMS and technical documentation.
Maintain clear communication with CDSCO during the query resolution phase.

Starting early and following this structured approach will help bring your artificial airway stylet to the Indian market efficiently and compliantly.

For personalized assistance, feel free to contact our regulatory experts who specialize in anesthesiology devices and CDSCO licensing procedures.

CDSCO License for Artificial airway stylet

Medical Device Information

Important Notice for Class A Devices

Intended Use