CDSCO License for Gastric tonometry catheter

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

As regulatory consultants with over 25 years of experience and having assisted more than 500 companies, we understand the complexities manufacturers and importers face when navigating the CDSCO licensing requirements for medical devices like the Gastric Tonometry Catheter. This device, classified as Class B under CDSCO regulations, plays a critical role in gastroenterology diagnostics by measuring partial pressure of CO2 (pCO2) in the stomach or sigmoid colon. Ensuring compliance with CDSCO mandates is crucial for successful market entry and patient safety.

CDSCO Regulatory Framework for Gastric Tonometry Catheters

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. Gastric Tonometry Catheters fall under the gastroenterology category and are governed by notification number 29/Misc./03/2020-DC (182), dated 27.09.2021. Being a Class B device, these catheters require a manufacturing license from the State Licensing Authority, commonly referred to as the MD5 license.

Risk Classification and License Requirements for Gastric Tonometry Catheters

Class B devices are considered low to moderate risk. According to CDSCO, manufacturers of Class B devices must obtain the MD5 manufacturing license (application form MD3) from the respective State Authority. The process includes obtaining a Test License (Form MD13), conducting product testing in government-approved labs, followed by an audit conducted by a notified body.

For a detailed understanding of medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Gastric Tonometry Catheters

1. Test License Application (Form MD13): The initial step is to apply for the Test License, which allows the device to be tested in CDSCO-approved laboratories. This process typically takes 1.5 to 2 months.

2. Product Testing: The gastric tonometry catheter must undergo rigorous testing to verify safety and efficacy. Utilize the list of Testing Laboratories approved by CDSCO.

3. Documentation Preparation: Compile all necessary documentation, including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) records, and risk management files.

4. Application Submission (Form MD3): Once testing and documentation are ready, submit the MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body listed here to verify compliance with manufacturing standards.

6. Resolution of Queries: Address any queries raised by the CDSCO or notified body promptly to avoid delays.

7. Grant of License (Form MD5): Upon successful audit and documentation approval, the MD5 license is granted.

For a stepwise walkthrough, explore our MD5 License Guide.

Manufacturing License Documents Required for Gastric Tonometry Catheters

• Company Constitution Documents: Certificate of incorporation, partnership deed, or trust deed.
• Proof of Ownership or Tenancy of Manufacturing Premises: Rent agreement or ownership documents.
• Technical Staff Qualifications and Experience: CVs and certificates of qualified personnel.
• Fire NOC and Pollution Control Board NOC: Valid clearances from relevant authorities.
• Device Master File (DMF): Detailed device description, design, and performance data. Our Device Master File guide provides comprehensive details.
• Plant Master File (PMF): Details of manufacturing premises and quality control measures. Refer to our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist as per Medical Device Rules.
• Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about implementation in our Risk Management resource.
• Test Reports: Results from government-approved testing laboratories.
• Labels and Instructions for Use (IFU): Device labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs.

Import License Process (MD15) for Gastric Tonometry Catheters

If you are an importer rather than a manufacturer, CDSCO requires an MD15 import license, granted by the Central Licensing Authority. The process spans approximately 5-6 months and involves:

• Preparing extensive documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, and device-specific files.
• Submitting the application on the CDSCO MD Online Portal.
• Responding to departmental queries.
• Receiving the import license (Form MD15).

For detailed insights, visit our Import License Guide.

Import License Documents Required

• Valid manufacturing license from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 Certification.
• CE Certificate or equivalent.
• Device Master File.
• Plant Master File.
• Wholesale Drug License.
• Company constitution documents.

Timeline and Processing Duration

These timelines are based on our experience assisting over 500 companies and assume diligent preparation and timely responses.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application.
• Product Fee: ₹500 per product.
• Testing and Audit Costs: Variable depending on notified body and testing lab; typically ranges from ₹50,000 to ₹100,000.

Budgeting for these costs upfront can prevent unexpected delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure every required document, such as the Device Master File and Plant Master File, is complete and accurate to avoid back-and-forth with CDSCO.
• Delayed Testing: Coordinate early with CDSCO-approved labs and schedule tests promptly.
• Audit Non-Compliance: Prepare thoroughly for notified body audits by maintaining stringent QMS and ensuring staff readiness.
• Query Resolution Delays: Assign dedicated personnel to handle CDSCO queries swiftly.

Our hands-on support can help mitigate these challenges effectively.

Expert Consultation and Support

With our 25+ years of regulatory expertise, we offer tailored consultancy services including:

• Gap analysis for documentation.
• Coordination with notified bodies and testing labs.
• Support during audits and inspections.
• Compliance training for your team.

Our proven track record guarantees a smoother licensing journey.

Getting Started with Your CDSCO License Application for Gastric Tonometry Catheters

1. Assess Your Device Classification: Confirm your device is Class B using CDSCO guidelines.

2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.

3. Engage with Approved Testing Laboratories: Schedule testing as soon as possible.

4. Prepare Comprehensive Documentation: Compile your Device Master File, Plant Master File, Risk Management, and QMS documents.

5. Plan for Audit: Identify and coordinate with a notified body from the official list.

6. Submit MD5 License Application: Apply on the CDSCO portal once test reports and documentation are ready.

7. Respond Promptly to Queries: Maintain communication with CDSCO and auditor teams for quick resolution.

By following these steps and leveraging expert guidance, manufacturers of Gastric Tonometry Catheters can confidently navigate the CDSCO licensing process and establish a strong foothold in the Indian healthcare market.

For personalized assistance or to kickstart your license application, contact our regulatory experts today.