CDSCO License for Nasopharyngeal airway

Comprehensive Guide to CDSCO Licensing for Nasopharyngeal Airway (Class B Medical Device)

As specialists with over 25 years of experience in navigating the complex regulatory landscape of medical devices in India, we understand the challenges manufacturers and importers face. The nasopharyngeal airway, classified as a Class B device under the anesthesiology category (Notification 29/Misc/03/2020-DC(177), dated 12.07.2021), requires meticulous compliance with the Central Drugs Standard Control Organization (CDSCO) regulations to ensure market entry.

Understanding the Nasopharyngeal Airway and Its Regulatory Importance

A nasopharyngeal airway is a soft rubber or plastic tube inserted through the nostril into the pharynx to maintain airway patency, especially in anesthetic and emergency settings. Given its critical use in patient safety, the Indian regulatory system classifies this device as Class B, indicating a low to moderate risk level, necessitating a controlled but streamlined licensing process.

CDSCO Regulatory Framework for Nasopharyngeal Airway

The CDSCO governs medical devices under the Medical Devices Rules, 2017. For Class B devices like the nasopharyngeal airway, the relevant manufacturing license is the MD5 license, issued by the State Licensing Authority. The regulatory journey involves initial product testing, documentation, audits by notified bodies, and final approval for manufacturing or import.

Risk Classification and License Requirements for Nasopharyngeal Airway

• Device Class: B (Low to Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3) for local manufacturing
• Import License: MD15 (if importing)

Since the device falls under Class B, manufacturers need to comply with MD5 licensing protocols, ensuring adherence to quality and safety standards as mandated.

Manufacturing License Process (MD5) for Nasopharyngeal Airway

1. Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license to conduct product testing. This takes approximately 1.5 to 2 months.

2. Product Testing: The nasopharyngeal airway must be tested at CDSCO-approved testing laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories for authorized facilities.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. Application Submission: Submit the MD5 application (Form MD3) through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit of manufacturing premises and quality systems is conducted by an authorized notified body. Check the notified bodies list for eligible auditors.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon satisfactory review and audit, the manufacturing license (Form MD5) is issued.

Manufacturing License Documents Required for Nasopharyngeal Airway

• Company Constitution documents (e.g., Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File detailing design, specifications, and manufacturing process (see our Device Master File guide)
• Plant Master File describing manufacturing infrastructure and quality systems (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File evidencing hazard analysis and mitigation strategies (Risk Management resource)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485 certification is advantageous)

Import License Process (MD15) for Nasopharyngeal Airway

If you are importing the nasopharyngeal airway into India, the MD15 license is mandatory. The process includes:

1. Document Compilation: Collect necessary documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale license.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond promptly to any queries raised.

4. License Issuance: The MD15 import license is granted, typically within 5-6 months.

Import License Documents Required

• Valid manufacturing license of the exporting company
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device and Plant Master Files
• Wholesale Drug License in India
• Company incorporation documents

Timeline and Processing Duration

For import licenses (MD15), expect approximately 5-6 months from application to approval.

Government Fees and Costs

• MD5 Manufacturing License:

  • Rs 5,000 per application
  • Rs 500 per product (nasopharyngeal airway counts as one product)

• Test License (MD13): Included in the application process

• Import License (MD15):

  • Rs 1,000 per site (Class B device)
  • Rs 50,000 per product

Budgeting accurately for these fees and ancillary costs such as notified body audits and testing lab charges is critical.

Common Challenges and Practical Solutions

• Delays in Document Preparation: We recommend starting documentation early and using standardized templates for Device and Plant Master Files.

• Non-compliance in Testing: Partner only with CDSCO-approved labs and conduct pre-testing internally to reduce failures.

• Audit Readiness: Engage experienced notified bodies listed on the CDSCO portal and prepare a checklist to ensure full compliance.

• Query Management: Maintain a dedicated regulatory liaison to handle CDSCO queries within 7-10 days.

Expert Consultation and Support

With a track record of assisting over 500 companies, we provide end-to-end support from initial classification and documentation to audit readiness and query resolution. Our expertise can reduce your approval timeline and avoid costly mistakes.

Getting Started with Your CDSCO License Application

1. Classify your device correctly: Confirm your nasopharyngeal airway is Class B under current CDSCO notifications.

2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.

3. Engage a CDSCO-approved testing laboratory: Book your product testing early.

4. Prepare your documentation: Utilize our Device and Plant Master File guides to expedite this process.

5. Schedule your notified body audit: Choose from the official notified bodies.

6. Submit your MD5 license application: Use Form MD3 on the CDSCO portal.

7. Respond promptly to queries: Keep close communication with the licensing authority.

Starting early and partnering with experienced consultants can streamline your market entry and ensure compliance with all regulatory mandates for your nasopharyngeal airway device.

For personalized assistance and a detailed roadmap tailored to your product, contact our regulatory experts today.