Focusing on non-standard automation equipment for medical devices
The difference between medical devices and medical equipment
2025-01-03
The difference between medical devices and medical equipment mainly lies in their definition, classification, purpose, and regulatory requirements.
Definition
Medical devices refer to disposable or reusable instruments, materials, or other products used for medical activities such as diagnosis, treatment, prevention, and monitoring. Medical equipment usually refers to larger, more complex, and expensive medical supplies with automated operation capabilities, used to perform specific medical testing, diagnosis, or treatment procedures.
Classification
Medical devices can be classified into Class I (low risk), Class II (medium risk), and Class III (high risk) based on their risk levels, each with different regulatory requirements involving approval processes, pre-market testing, production standards, and post market monitoring. Medical equipment can be divided into imaging equipment, diagnostic equipment, therapeutic equipment, monitoring equipment, surgical equipment, etc. based on their functions.
Purpose:
The range of medical devices is very wide, including simple surgical knives, blood pressure monitors, complex X-ray machines, MRI scanners, etc. Medical equipment is more focused on larger, more complex, and more expensive medical technology products, such as CT scanners, ultrasound imaging systems, etc.
Regulatory requirements
The regulatory requirements for medical devices and medical equipment also vary. Medical devices need to comply with strict regulations and standards to ensure safety and effectiveness, while medical devices typically require specialized operators and regular calibration and maintenance to ensure the accuracy of measurement results.
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