What Is the Classification of Infusion Pump Devices?

Infusion pumps are medical devices used to deliver fluids like medications, nutrients, or saline solutions into a patient’s body in controlled amounts. These devices are essential in both hospitals and home care setups. When importing or manufacturing these devices in India, it’s crucial to understand the classification of infusion pump devices under CDSCO guidelines. This classification decides the level of regulation, documentation, and approvals required.

Understanding this classification of infusion pump devices helps ensure safe usage and full compliance with Indian medical device laws.

What Are Infusion Pump Devices and Their Purpose?

Infusion pump devices are machines that deliver precise volumes of liquid into a patient’s bloodstream. They are often used in:

• Hospitals and ICUs
• Chemotherapy treatments
• Insulin delivery for diabetic patients
• Nutritional therapy

These pumps are often used when accurate dosages over a long time are required.

What Is the Classification of Infusion Pump Devices in India?

The classification of infusion pump devices in India is based on their intended use and risk level, as per CDSCO guidelines. Here’s the classification:

S.No.	Device Type	Risk Class	CDSCO Class	Examples
1.	Syringe Pumps	Medium Risk	Class B	Deliver small doses like insulin
2.	Volumetric Infusion Pumps	Medium Risk	Class B	Deliver large fluid volumes
3.	Ambulatory Infusion Pumps	High Risk	Class C	Used by patients at home
4.	PCA Pumps (Patient-Controlled Analgesia)	High Risk	Class C	Pain medication on demand
5.	Implantable Infusion Pumps	Very High Risk	Class D	Implanted inside the body for the long term

Why Is Classification Important Before Importing?

Knowing the classification of infusion pump devices helps in:

• Understanding what documents you need
• Identifying the right CDSCO license (MD-14, MD-15)
• Avoiding compliance delays or rejection
• Reducing regulatory risks

Incorrect classification can result in penalties, delays, or seizure of products.

What Are the Regulatory Requirements Based on Classification?

S.No.	CDSCO Class	License Required	Testing	QMS Standard
1.	Class B	MD-15	Basic performance tests	ISO 13485 certification
2.	Class C	MD-15	Clinical & technical data	ISO 13485 + more records
3.	Class D	MD-15	Strict clinical validation	High QMS + Clinical trials

Documents Needed to Import Infusion Pumps

Here is a general list of documents required depending on the classification:

• Power of Attorney
• ISO 13485 certificate
• Free Sale Certificate from the country of origin
• Device Master File (DMF)
• Plant Master File (PMF)
• Labels and Instructions
• Clinical Evaluation Reports
• Performance Testing (especially for Class C & D)

Do You Need a Test License Before Importing?

Yes, if you want to import the infusion pump for demonstration or testing purposes, apply for a Form MD-16 license under CDSCO.

Are Infusion Pumps Considered Medical Devices in India?

Yes. Under CDSCO rules, infusion pumps are classified as medical devices and must follow the Medical Device Rules, 2017.

How Does CDSCO Decide the Classification?

CDSCO uses parameters like:

• Intended use
• Duration of use (short-term, long-term)
• Degree of invasiveness
• Technology used
• Whether it’s life-supporting or not

These factors determine whether the device is Class B, C, or D.

Challenges in Importing High-Class Infusion Pumps (C/D)

• Requires more clinical data
• Long approval timelines
• QMS audits may be required
• Renewal and post-approval compliance are strict

How ELT Corporate Can Help You with the Classification of Infusion Pump Devices?

If you’re confused about the classification or CDSCO licensing, ELT Corporate is here to help. We are experts in the classification of infusion pump devices and ensure your compliance process is smooth.

Why Choose ELT Corporate India’s Trusted CDSCO Consultancy?

If you’re confused about the classification or CDSCO licensing, ELT Corporate is here to help. We are experts in the classification of infusion pump devices and ensure your compliance process is smooth.

• Experts in CDSCO device classification and import licenses
• Help you file MD-14/15/16 depending on the class
• End-to-end documentation and submission
• Quick turnaround and no delays
• Guidance for clinical data & test reports
• Support in labelling as per Indian rules
• Regular follow-ups with CDSCO officials
• 2500+ licenses completed for global brands