CDSCO License for General-purpose infusion pump, mechanical, reusable

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

Introduction: Understanding Your Device and Regulatory Importance

The general-purpose infusion pump, mechanical and reusable, is a critical medical device widely used in oncology for continuous or intermittent infusion of medications such as antibiotics, chemotherapy agents, or analgesics. This non-electric, spring-powered device enables patient mobility and can support patient-controlled analgesia (PCA), making it indispensable in home care settings.

Given its significant role in therapy and patient safety, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing in India. Navigating the CDSCO licensing process for this Class C device requires detailed understanding of regulatory frameworks, risk classifications, document submissions, and timelines.

With over 25 years of experience assisting 500+ companies, we provide practical, step-by-step guidance to streamline your journey toward obtaining your MD9 manufacturing license.

CDSCO Regulatory Framework for Mechanical Infusion Pumps

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, classifying devices based on risk. Mechanical infusion pumps fall under Class C due to their moderate risk nature, especially considering their use in oncology and home care.

Manufacturers of Class C devices must apply to the Central Licensing Authority for the MD9 license. The regulatory pathway includes obtaining a test license (MD13), product testing by CDSCO-approved labs, documentation, audits, and final license grant.

All applications and communications are processed via the CDSCO MD Online Portal, ensuring transparency and tracking.

Risk Classification and License Requirements for Your Device

Our infusion pump is classified as Class C based on the MDR classification criteria due to:

• Intended use involving drug delivery with potential moderate risk
• Reusable nature demanding rigorous quality and safety controls
• Use in high-risk therapeutic areas like oncology

For Class C devices, the license type required is the MD9 Manufacturing License, applied through Form MD7.

Key Points:

• Application submitted to Central Licensing Authority
• Requires pre-approval testing and compliance audits
• Total process duration: Approximately 4-5 months

For detailed classification insights, visit our guide on Medical Device Classification.

Step-by-Step Manufacturing License Process (MD9 License)

1. Obtain Test License (MD13): Submit Form MD13 to get permission for product testing. This stage takes about 1.5 to 2 months.

2. Product Testing: Conduct testing at CDSCO-approved labs to verify safety and performance. Access the updated Testing Laboratories list.

3. Documentation Preparation: Compile all necessary documents, including Device Master File, Plant Master File, risk management, and quality system documents.

4. Submit MD9 Application (Form MD7): Apply through the CDSCO portal.

5. Audit by CDSCO Inspectors: Following document review, CDSCO conducts on-site audits to verify compliance.

6. Respond to Queries: Address any clarifications or additional information requests promptly.

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

For an in-depth walkthrough, refer to our MD9 License Guide.

Mandatory Documents for MD9 Manufacturing License

To ensure a smooth application process, prepare the following comprehensive documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Personnel (Qualifications and Experience)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) — Including design, specifications, and manufacturing processes. See our Device Master File Guide
• Plant Master File (PMF) — Detailing manufacturing facilities and equipment. Learn more in our Plant Master File Guide
• Essential Principles Compliance Checklist
• Risk Management File — Demonstrating hazard analysis and mitigation aligned with ISO 14971. For best practices, visit Risk Management
• Test Reports from CDSCO-Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents — Typically ISO 13485:2016 certification and internal procedures

Attention to detail in documentation reduces audit queries and expedites approval.

Import License Process (MD15) Overview

For companies importing the mechanical infusion pump into India, the MD15 license is mandatory. However, since your device is Class C and you are focusing on manufacturing, the primary emphasis is on the MD9 license.

That said, importers must provide additional documents such as Free Sale Certificate and CE Certificate along with manufacturing licenses from the country of origin.

For detailed import license guidance, explore our Import License Guide.

Timeline and Processing Duration

Planning ahead and prompt responses to CDSCO queries are crucial to avoid delays.

Government Fees and Associated Costs

For the MD9 license of a Class C device like the infusion pump:

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

Additional costs include:

• Testing laboratory fees (varies by lab and tests required)
• Consultancy fees if opting for external support
• Preparation and certification costs for QMS and technical documentation

Budgeting realistically for these expenses ensures uninterrupted progress.

Common Challenges and Practical Solutions

• Incomplete Documentation: Often leads to repeated queries. Use checklists and expert reviews before submission.

• Prolonged Testing Delays: Book slots early at notified testing labs and confirm test protocols.

• Audit Readiness: Conduct internal mock audits to prepare for CDSCO inspections.

• Regulatory Updates: Stay informed on MDR changes via official notifications to remain compliant.

• Labeling and IFU Compliance: Ensure labels meet CDSCO and Indian language requirements to avoid rejection.

Our team’s experience with over 500 successful license grants equips us to anticipate and resolve these common pain points efficiently.

Expert Consultation and Support

Navigating the CDSCO landscape for Class C infusion pumps can be complex. Leveraging expert consultants accelerates the process:

• Tailored gap analysis of your documentation
• Assistance with test license and product testing coordination
• Preparation for audits and compliance training
• Ongoing regulatory updates and post-license support

Partnering with seasoned consultants reduces errors and maximizes your chances of timely approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status to select MD9 licensing pathway.

2. Initiate Documentation: Start compiling Device Master File, Plant Master File, risk management files, and QMS certifications.

3. Apply for Test License (MD13): Submit early on the CDSCO MD Online Portal.

4. Schedule Product Testing: Contact CDSCO-approved labs promptly via their official listings.

5. Prepare for Audit: Organize your manufacturing site and staff for the upcoming inspection.

6. Submit MD9 Application: Complete Form MD7 with all supporting documents through the online portal.

7. Respond Promptly to Queries: Designate a regulatory point person to handle communications.

By following these actionable steps and leveraging expert guidance, your pathway to obtaining the MD9 manufacturing license for your reusable mechanical infusion pump can be significantly streamlined.

For personalized assistance or to initiate your application process, contact our regulatory experts today and benefit from our proven track record of 500+ successful CDSCO license grants.