CDSCO License for Catheter-balloon inflator, reprocessed

Comprehensive Guide to CDSCO Licensing for Catheter-Balloon Inflator, Reprocessed (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the Catheter-balloon inflator, reprocessed. As a sterile device intended to manually inflate and regulate balloon catheters during critical procedures such as angiography, angioplasty, and gastrointestinal interventions, it falls under the Gastroenterology category and is classified as a Class B medical device under the CDSCO framework. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you with a detailed, step-by-step guide to successfully register and manufacture this device in India.

CDSCO Regulatory Framework for Catheter-Balloon Inflator, Reprocessed

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. The Catheter-balloon inflator, reprocessed is notified under the CDSCO gazette notification number 29/Misc./03/2020-DC (182) dated 27.09.2021. This notification ensures that reprocessed devices meet stringent safety and efficacy standards, critical for patient safety.

Manufacturers of this Class B device must obtain a manufacturing license under the MD5 license category, issued by the State Licensing Authority. This regulatory pathway includes adherence to Good Manufacturing Practices (GMP), device testing, quality management systems, and compliance with essential principles.

Risk Classification and License Requirements for Class B Devices

According to CDSCO's classification system, Class B devices are considered low to moderate risk. The Catheter-balloon inflator, reprocessed falls under this category due to its invasive nature but limited duration of use.

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Application Form: MD3
• Issuing Authority: State Licensing Authority
• Total Processing Time: Approximately 3 to 4 months (including test license and audit)
• Government Fees: Rs. 5,000 per application + Rs. 500 per product

For detailed classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Catheter-Balloon Inflator

The MD5 license process is meticulous and requires several stages:

1. Test License Application (Form MD13): Before the manufacturing license, you must obtain a test license, which allows you to manufacture the device for testing purposes. This takes around 1.5 to 2 months.

2. Product Testing: The device must be tested at CDSCO-approved government laboratories for compliance with safety and performance standards. You can find a list of these Testing Laboratories here.

3. Documentation Preparation: Compile all required documents, including Device Master File, Plant Master File, Risk Management File, and others detailed below.

4. License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A mandatory audit of your manufacturing facility and quality systems is conducted by a notified body. Refer to the list of notified bodies authorized for MD5 audits.

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

7. License Grant: Upon satisfactory evaluation, the MD5 license is granted, allowing you to manufacture and sell the device in India.

Manufacturing License Documents Required

For the Catheter-balloon inflator, the following documents must be prepared meticulously:

• Company Constitution (Incorporation certificate, partnership deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details (Qualifications and experience of responsible persons)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Comprehensive documentation on device design, specifications, and manufacturing process. Our Device Master File guide provides practical tips.
• Plant Master File (PMF): Details of the manufacturing facility, equipment, and quality systems. See our Plant Master File guide for insights.
• Essential Principles Checklist: Compliance with Indian and international medical device standards.
• Risk Management File: Demonstrates implementation of risk assessment and mitigation measures. Learn more about Medical Device Risk Management.
• Test Reports: From CDSCO-approved labs confirming device safety.
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
• Quality Management System (QMS) Documents: Including SOPs, CAPA, internal audit reports, etc.

Import License Process (MD15) for Catheter-Balloon Inflator

If you are an importer of the Catheter-balloon inflator, an MD15 import license issued by the Central Licensing Authority is mandatory. The process is as follows:

• Prepare and submit application on Form MD14 via the CDSCO MD Online Portal.
• Include mandatory documents such as valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• The process typically takes 5 to 6 months.
• Government fees vary by device class; for Class B devices, expect approximately $2,000 per site and$1,000 per product.

For a detailed overview, refer to our Import License guide.

Import License Documents Required

Essential documents for MD15 include:

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

Timeline and Processing Duration

Total Time: Approximately 3 to 4 months for MD5 license.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Usually included in the overall process
• Audit Fees: Paid to notified body as per their schedule

Budgeting for these fees upfront and engaging experienced consultants can help avoid costly delays.

Common Challenges and Practical Solutions

• Challenge: Delays in test license approval

  • Solution: Submit a complete and error-free MD13 application; follow up regularly on the portal.

• Challenge: Lack of clarity on documentation standards

  • Solution: Use expert-prepared templates and guidelines for Device and Plant Master Files.

• Challenge: Audit non-compliance

  • Solution: Conduct pre-audit internal assessments and train staff thoroughly.

• Challenge: Query resolution delays

  • Solution: Prepare comprehensive responses promptly and maintain clear communication with CDSCO.

Expert Consultation and Support

With 25+ years of experience and over 500 successful CDSCO license approvals under our belt, we offer:

• End-to-end regulatory consultancy
• Documentation drafting and review
• Mock audits and gap analysis
• Liaison with CDSCO and notified bodies
• Training on compliance and QMS implementation

Our expertise ensures your Catheter-balloon inflator manufacturing or import license is granted smoothly and efficiently.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device class as B using the official CDSCO guidelines.

2. Create an Account and Register on the CDSCO MD Online Portal: This is mandatory for all submissions.

3. Prepare Your Test License Application (Form MD13): Gather required documents and submit early to avoid bottlenecks.

4. Identify a CDSCO-Approved Testing Lab: Schedule necessary product testing.

5. Compile Comprehensive Documentation: Use our Device Master File guide and Plant Master File guide for reference.

6. Engage a Notified Body for Pre-audit Assessment: Early engagement helps identify gaps.

7. Submit Manufacturing License Application (Form MD3) and Track Progress: Utilize the online portal for transparency.

8. Respond to Queries Promptly: Maintain open communication with CDSCO officials.

By taking these actionable steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for the Catheter-balloon inflator, reprocessed. Contact us today to initiate your application or to receive personalized assistance tailored to your unique business needs.