CDSCO License for General-purpose infusion pump, mechanical, single-use

Comprehensive Guide to CDSCO Licensing for General-Purpose Mechanical Single-Use Infusion Pumps (Class C)

Entering the Indian medical device market with a general-purpose infusion pump, mechanical, single-use requires navigating the stringent regulatory framework established by the Central Drugs Standard Control Organization (CDSCO). This device, classified as Class C due to its moderate to high risk and critical use in oncology therapies such as chemotherapy and analgesia, demands meticulous compliance to ensure patient safety and regulatory approval.

With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we offer you a detailed, practical roadmap to obtain both manufacturing (MD9) and import (MD15) licenses for this device type.

CDSCO Regulatory Framework for Mechanical Single-Use Infusion Pumps

The CDSCO regulates medical devices under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017. Your device falls under the Class C category, which includes devices with moderate to high risk, typically requiring central licensing authority oversight.

Given the device's critical role in delivering precise fluid doses for oncology patients, regulatory authorities mandate rigorous documentation, testing, and audits prior to market authorization.

For detailed classification information, refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Class C Devices

• Risk Class: C
• Regulatory Authority: Central Licensing Authority (CDSCO Headquarters)
• Required Manufacturing License: MD9 (Application Form MD7)
• Required Import License: MD15 (Application Form MD14)
• Testing: Mandatory testing at CDSCO-approved laboratories
• Audit: Inspection by CDSCO officials

The MD9 manufacturing license process is more detailed than Class A/B devices, involving a test license, product testing, document submission, and a formal audit. The import license process (MD15) requires robust documentation, including proof of manufacturing compliance.

Manufacturing License Process (MD9) for Class C Infusion Pumps

1. Test License Application (Form MD13): Initiate with a test license application to legally produce the device for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: Obtain device testing from government-approved labs. Testing includes biocompatibility, mechanical performance, and safety parameters.

3. Documentation Preparation: Compile comprehensive documents such as Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) evidence.

4. MD9 License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors conduct a thorough audit of your manufacturing site and documentation.

6. Query Resolution: Address any observations or queries raised during inspection promptly to avoid delays.

7. License Grant: Upon satisfactory compliance, the MD9 license is granted.

For a deeper dive into the MD9 license process, consult our MD9 License Guide.

Manufacturing License Documents Required for MD9

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Personnel
• Fire NOC and Pollution Control Board NOC
• Device Master File (detailed design and manufacturing process) — see our Device Master File guide
• Plant Master File — refer to our Plant Master File Guide
• Essential Principles Compliance Checklist
• Risk Management File compliant with ISO 14971 — learn more about Risk Management
• Test Reports from CDSCO-Approved Testing Laboratories (refer to Testing Laboratories List)
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (preferably ISO 13485:2016)

Import License Process (MD15) for Class C Infusion Pumps

The import license process is managed centrally by CDSCO and typically spans 5 to 6 months. Unlike the manufacturing license, no test license is required for imports, but documentation must be exhaustive.

Steps include:

1. Document Preparation: Assemble relevant certifications such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE marking, Device Master File, and Plant Master File.

2. License Application (Form MD14): Submit the MD15 application on the CDSCO MD Online Portal.

3. Query Resolution: Promptly respond to any queries raised during the evaluation.

4. License Issuance: Upon approval, the MD15 import license is granted.

Our detailed Import License Guide provides step-by-step assistance.

Import License Documents Required

• Valid Manufacturing License from Origin Country
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents
• Detailed Product Information and Labels

Timeline and Processing Duration

Planning for contingencies such as audit observations or additional information requests is essential to prevent unexpected delays.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License:

  • For Class C devices: ₹3,000 per site
  • Per Product Fee: ₹1,500

Additional costs include testing fees at approved labs, audit fees (if any), and consultancy or document preparation expenses.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved laboratories early and schedule testing slots in advance. Maintain clear communication to avoid backlog.

Challenge 2: Incomplete Documentation

Solution: Use checklists based on CDSCO guidelines and consult templates for DMF and PMF to ensure completeness.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal mock audits and train staff on CDSCO audit expectations. Address any gaps before official inspections.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to handle CDSCO communications promptly and thoroughly.

Expert Consultation and Support

Navigating the CDSCO licensing maze can be complex, especially for Class C devices like mechanical infusion pumps with critical oncology applications. Our seasoned regulatory consultants deliver:

• Tailored document preparation
• Liaison with notified bodies and testing labs
• Audit readiness training
• Query handling and follow-up

Our track record includes successful MD9 and MD15 licenses for over 500 medical device companies, ensuring smooth market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class C using the Medical Device Classification guide.

2. Compile Preliminary Documents: Gather company incorporation, premises proof, and technical personnel details.

3. Initiate Test License (MD13): Apply for the test license via the CDSCO MD Online Portal.

4. Coordinate Product Testing: Schedule testing at government-approved labs listed on the CDSCO portal.

5. Prepare Device and Plant Master Files: Develop comprehensive DMF and PMF aligned with CDSCO standards.

6. Submit Manufacturing License Application (MD7): Once testing and documentation are complete, apply for the MD9 license.

7. Plan for Audit: Prepare your facility and QMS for the CDSCO inspection.

8. For Import: Parallelly, prepare import documentation and apply for MD15 license as needed.

Embarking with a clear, stepwise approach backed by expert guidance ensures timely approval and successful market entry for your general-purpose mechanical infusion pump.

For personalized assistance or queries, connect with us to leverage our 25+ years of CDSCO regulatory expertise.