CDSCO License for Arterial Catheter

Comprehensive Guide to CDSCO Licensing for Arterial Catheters (Class B Medical Device)

Arterial catheters are vital medical devices designed to facilitate access to specific regions of the coronary and peripheral arterial vasculature, typically used alongside steerable guidewires. Classified under Class B (low-moderate risk) by the CDSCO, these devices require a stringent regulatory process to ensure safety and efficacy before entering the Indian market. With over 25 years of experience and having supported 500+ companies, we offer detailed guidance to help manufacturers and importers navigate the complexities of obtaining CDSCO licenses for arterial catheters.

CDSCO Regulatory Framework for Arterial Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules, 2017, notified via Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Arterial catheters fall under Class B, which demands compliance with specific licensing procedures to assure product quality and patient safety.

The regulatory framework mandates manufacturers to obtain a Manufacturing License (MD5) granted by the State Licensing Authority. Importers must secure an Import License (MD15) from CDSCO’s Central Licensing Authority.

Risk Classification and License Requirements for Arterial Catheters

As a Class B device, arterial catheters are considered low to moderate risk, requiring:

• Manufacturing License (MD5) for domestic production.
• Test License (MD13) initially for product testing.
• Compliance with quality management systems and technical documentation.

This classification ensures a balance between regulatory oversight and timely market access.

Manufacturing License Process (MD5) for Arterial Catheters

The MD5 license process involves several key stages:

1. Test License (MD13) Application: Submit for a test license on Form MD13 through the CDSCO MD Online Portal. This phase takes approximately 1.5 to 2 months.

2. Product Testing: Get the arterial catheter tested at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized facilities.

3. Documentation Preparation: Compile comprehensive technical files, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.

4. Application Submission: File the MD5 license application using Form MD3 on the CDSCO portal.

5. Audit by Notified Body: A notified body conducts a plant and QMS audit. Find accredited bodies on the Notified Bodies List.

6. Queries Resolution: Address any queries raised by the licensing authority or auditors promptly.

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

The entire process spans approximately 3 to 4 months, assuming timely responses.

Manufacturing License Documents Required for Arterial Catheters

Successful MD5 applications must include:

• Company Constitution (MOA/AOA)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualification and experience details
• Fire and Pollution NOCs
• Device Master File detailing design and specifications (Guide here)
• Plant Master File outlining manufacturing facilities (Guide here)
• Essential Principles Checklist
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Arterial Catheters

For importers, the MD15 license is mandatory and involves:

1. Documentation Preparation: Collect all required documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO certificates, CE marking, and technical files.

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

3. Queries Resolution: Promptly address any queries raised by CDSCO.

4. License Grant: Upon clearance, the Import License (Form MD15) is issued.

The import license process typically takes 5 to 6 months.

Import License Documents Required for Arterial Catheters

Key documents include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

For import licenses, expect 5 to 6 months from application submission to license grant.

Government Fees and Costs for Arterial Catheters (Class B)

• MD5 License:

  • Application Fee: INR 5,000
  • Per product fee: INR 500

• Test License (MD13): Usually included within the overall process costs

• Import License (MD15):

  • Site Fee: USD 1,000
  • Per product fee: USD 50

Additional costs include testing fees at government-approved labs and notified body audit charges.

Common Challenges and Practical Solutions

• Delayed Testing Results: Engage with testing labs early and confirm sample requirements to avoid rejections.

• Incomplete Documentation: Utilize a detailed checklist aligned with CDSCO requirements to ensure no missing documents.

• Audit Non-Compliance: Prepare your facility with pre-audit internal checks and ensure QMS conformity.

• Query Delays: Respond promptly and comprehensively to queries to avoid prolonged processing times.

• Understanding Regulatory Changes: Stay updated with CDSCO notifications and amendments related to medical devices.

Expert Consultation and Support

Navigating the CDSCO licensing for arterial catheters requires expertise and attention to detail. We have successfully supported over 500 companies in obtaining their licenses by providing:

• Regulatory strategy and classification assistance
• Document preparation and review
• Liaison with notified bodies and testing labs
• Audit preparedness training
• Post-approval compliance support

Our expert team ensures your application is robust and compliant, minimizing delays and rejections.

Getting Started with Your CDSCO License Application for Arterial Catheters

1. Assess Risk Classification: Confirm your device as Class B using the Medical Device Classification guide.

2. Plan Testing: Contact CDSCO-approved testing laboratories early (Testing Labs List).

3. Prepare Documentation: Develop Device Master File and Plant Master File per guidelines.

4. Submit Test License Application: Apply for MD13 via the CDSCO MD Online Portal.

5. Coordinate Audits: Schedule and prepare for notified body audits using the Notified Bodies List.

6. Engage Expert Support: Consider partnering with experienced regulatory consultants to streamline the process.

By following these steps diligently, manufacturers and importers can efficiently secure CDSCO licenses for arterial catheters, enabling access to the growing Indian healthcare market with confidence and compliance.