CDSCO License for Oropharyngeal airway

Introduction to Oropharyngeal Airway and Its Regulatory Importance

The Oropharyngeal Airway is a vital anesthesiology device designed as a curved metal or plastic tube. Its primary function is to maintain airway patency by preventing the tongue from obstructing airflow, thereby facilitating effective gas exchange or suctioning. Given its critical role in airway management during anesthesia and emergency care, regulatory compliance is paramount to ensure safety and efficacy.

In India, the regulation of this device falls under the purview of the Central Drugs Standard Control Organization (CDSCO). As a Class A medical device, the Oropharyngeal Airway requires a manufacturing license under the MD5 scheme. Understanding the regulatory framework, timelines, documentation, and costs involved is essential for manufacturers and importers aiming to enter the Indian market.

CDSCO Regulatory Framework for Oropharyngeal Airway (Class A Device)

The CDSCO categorizes medical devices based on risk, with Class A representing low-risk devices like the Oropharyngeal Airway. The regulatory framework ensures that such devices meet stringent safety, quality, and performance standards before market introduction.

The specific notification governing this device is 29/Misc/03/2020-DC(177), dated 12.07.2021, which classifies the Oropharyngeal Airway under anesthesiology and mandates compliance with the MD5 licensing process.

Risk Classification and License Requirements for Oropharyngeal Airway

As a Class A device, the Oropharyngeal Airway is subject to the following:

• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Relevant Application Form: MD3 for manufacturing license, MD13 for Test License
• Process Duration: Approximately 3-4 months for the entire licensing process
• Fees: Rs. 5,000 per application plus Rs. 500 per product

This classification implies a relatively straightforward licensing route compared to higher-risk devices, but compliance with documentation, testing, and audits remains rigorous.

Manufacturing License Process for Oropharyngeal Airway (MD5)

Our extensive experience with over 500 companies indicates that the MD5 licensing process for Class A devices involves the following sequential steps:

1. Apply for Test License on Form MD13: This preliminary license allows product testing and usually takes about 1.5-2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with essential principles and safety standards. A list of Testing Laboratories is available on the CDSCO portal.
3. Documentation Preparation: Prepare comprehensive technical files, including Device Master File and Plant Master File.
4. Submit Manufacturing License Application on Form MD3: This is done through the CDSCO MD Online Portal.
5. Audit by Notified Body: The State Licensing Authority mandates an audit by a notified body. Refer to the current Notified Bodies List for approved auditors.
6. Query Resolution: Address any observations from the audit or CDSCO queries promptly.
7. Grant of MD5 License: Upon satisfactory review, the license is granted on Form MD5.

Manufacturing License Documents Required for Oropharyngeal Airway

Preparing a robust documentation package is critical. For the Oropharyngeal Airway MD5 license, the following are mandatory:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association.
• Proof of Ownership or Lease of Premises: Valid documents showcasing legal possession.
• Technical Staff Details: Qualification and experience of personnel involved in manufacturing.
• Fire NOC and Pollution Control NOC: From relevant local authorities.
• Device Master File (DMF): Detailed product specifications, design, manufacturing process, and quality controls. Our Device Master File Guide can assist in preparation.
• Plant Master File (PMF): Details of manufacturing facilities, equipment, and quality management system. See our Plant Master File Guide for best practices.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules.
• Risk Management File: Hazard analysis and mitigation strategies specific to the Oropharyngeal Airway. Refer to our Risk Management guide for practical insights.
• Test Reports: From government-approved labs validating safety and performance.
• Product Labels and Instructions for Use (IFU): As per CDSCO guidelines.
• Quality Management System Documents: Evidence of ISO 13485 certification or equivalent.

Import License Process for Oropharyngeal Airway (MD15)

While the primary focus here is manufacturing, importers of the Oropharyngeal Airway must obtain an MD15 import license from the Central Licensing Authority. The process includes:

• Application on Form MD14 via the CDSCO MD Online Portal.
• Submission of required documentation (manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, company constitution).
• Resolution of queries raised by CDSCO.
• Grant of license on Form MD15.

The import license process typically takes 5-6 months, with government fees depending on the risk class (Class A incurs $1000 per site and$50 per product).

Import License Documents Required for Oropharyngeal Airway

Key documents include:

• Valid Manufacturing License from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Marking Certificate.
• Device Master File and Plant Master File.
• Wholesale license for distribution.
• Company constitution and address proof.

For detailed guidance, explore our Import License Guide.

Timeline and Processing Duration for MD5 License

For Oropharyngeal Airway devices, the entire MD5 licensing process generally spans 3 to 4 months:

• Test License (Form MD13): 1.5 to 2 months.
• Product Testing: 2 to 4 weeks depending on lab availability.
• Document Preparation: Overlaps with testing; 2 to 3 weeks.
• Application Submission and Audit: 3 to 4 weeks.
• Query Resolution: 2 to 3 weeks.

Manufacturers should anticipate administrative delays and prepare for proactive follow-ups to meet timelines.

Government Fees and Costs Involved

The fee structure for MD5 license for Oropharyngeal Airway includes:

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

Additional costs include:

• Testing laboratory charges (varies by lab and number of tests).
• Fees for notified body audits.
• Costs for document preparation, including consulting fees if outsourced.

Budgeting accurately for these elements minimizes surprises during the licensing process.

Common Challenges and Solutions in MD5 Licensing

Challenge: Delays in product testing due to lab backlogs.

Solution: Schedule testing early; consult the CDSCO Testing Laboratories list to select less busy labs.

Challenge: Incomplete or inconsistent documentation.

Solution: Utilize expert checklists and guides such as our Device Master File Guide and Plant Master File Guide to ensure completeness.

Challenge: Non-compliance findings during notified body audits.

Solution: Conduct internal pre-audit assessments to identify gaps before official audits.

Challenge: Lack of clarity on risk management documentation.

Solution: Implement structured risk management protocols as detailed in our Risk Management guide.

Expert Consultation and Support for Oropharyngeal Airway Licensing

With over 25 years of regulatory consulting experience and 500+ clients successfully licensed, we provide tailored support through every step:

• Pre-assessment of device classification and applicable regulations.
• Assistance in compiling and reviewing technical files.
• Coordination with testing laboratories and notified bodies.
• Liaison with CDSCO authorities for smooth query resolution.
• Training on quality management and compliance best practices.

Our in-depth knowledge of CDSCO processes ensures efficient licensing and market entry.

Getting Started with Your CDSCO License Application for Oropharyngeal Airway

To begin your journey toward obtaining an MD5 manufacturing license for the Oropharyngeal Airway, follow these actionable steps:

1. Classify Your Device: Confirm Class A status using the Medical Device Classification resource.
2. Prepare Technical Documentation: Start with creating or updating your Device Master File and Plant Master File.
3. Apply for the Test License (Form MD13): Submit your application through the CDSCO MD Online Portal.
4. Plan Product Testing: Engage a CDSCO-approved testing laboratory early.
5. Compile Quality Management System Documents: Ensure ISO 13485 certification is in place.
6. Schedule Notified Body Audit: Select an approved notified body from the Notified Bodies List and prepare for audit.
7. Submit Manufacturing License Application (Form MD3): After successful testing and documentation, apply via the CDSCO portal.

We recommend partnering with experienced regulatory consultants to navigate these steps efficiently and avoid common pitfalls. Reach out to us for personalized guidance and to leverage our proven expertise in CDSCO licensing for anesthesiology devices like the Oropharyngeal Airway.