Drugdu.com expert's response:

Active medical devices refer to any medical devices that rely on electrical energy or other forms of energy (such as chemical energy, mechanical energy, etc.) to function, rather than energy directly generated by the human body or gravity. These devices typically require an external power source or built-in energy supply to fulfill their intended purposes and are widely used in various medical fields, including diagnosis, treatment, monitoring, and rehabilitation.

I. Core Characteristics

Energy Dependency: They must rely on external or internal energy sources (such as batteries, power adapters, chemical cells, etc.) to operate normally.

Functional Complexity: They usually incorporate electronic, mechanical, or software components, enabling them to perform precise operations or data processing.

Risk Level: According to the "Classification Rules for Medical Devices," active medical devices are classified as having a higher risk level. They may involve direct electrical stimulation, energy release, or complex control mechanisms that affect patients or users, necessitating stringent regulation.

II. Common Types

Diagnostic Devices

Medical Imaging Equipment: Such as X-ray machines, CT scanners, MRI (Magnetic Resonance Imaging) units, and ultrasound diagnostic instruments.

Vital Sign Monitors: Electrocardiographs (ECG), electroencephalographs (EEG), blood pressure monitors, and pulse oximeters.

Endoscopic Systems: Electronic endoscopes (such as gastroscopes and colonoscopes) and their associated equipment.

Therapeutic Devices

Energy-Based Therapy Equipment: Laser therapy devices, radiofrequency ablation devices, high-frequency electrosurgical units, and extracorporeal shock wave lithotripters.

Respiratory Support Devices: Ventilators, oxygen concentrators, and anesthesia machines.

Rehabilitation Equipment: Electric wheelchairs, rehabilitation training robots, and neuromuscular electrical stimulators.

Auxiliary Devices

Infusion/Syringe Pumps: Precisely control the delivery rate of drugs or fluids.

Extracorporeal Circulation Devices: Such as artificial heart-lung machines and hemodialysis machines.

Surgical Navigation Systems: Combine imaging technology to assist doctors in performing precise surgeries.

Differences from Passive Medical Devices

Passive Medical Devices: Do not rely on external energy sources and function solely through physical means (such as mechanical structures or material properties), such as surgical scalpels, syringes, bandages, and artificial joints.

Active Medical Devices: Require energy to operate, are more functionally complex, and may involve electronic control, energy conversion, or data processing.

III. Regulatory and Safety Requirements

Due to their direct impact on patient safety, active medical devices are subject to extremely strict regulation worldwide. For example:

China: They must undergo registration or filing with the National Medical Products Administration (NMPA) and comply with the "Regulations on the Supervision and Administration of Medical Devices" and mandatory standards (such as the GB 9706 series).

European Union: They must obtain CE certification and comply with the requirements of the Medical Device Regulation (MDR).

United States: They must undergo the 510(k) or Pre-Market Approval (PMA) process with the Food and Drug Administration (FDA).

Development Trends

With technological advancements, active medical devices are evolving towards intelligence, portability, and remote operation, such as:

Wearable Devices: Such as smart bracelets and portable electrocardiographs, enabling real-time health monitoring.

Telemedicine: Utilizing 5G/Internet of Things (IoT) technology to facilitate remote diagnosis and treatment.

Artificial Intelligence Integration: AI-assisted diagnostic systems and intelligent surgical robots, enhancing medical precision.

VI. Summary

Active medical devices are a core component of modern healthcare systems. Their high reliance on energy and complex technology provides efficient and precise tools for disease diagnosis, treatment, and rehabilitation. However, their high-risk nature also demands stringent regulatory and safety standards to ensure the safety of patients and users.'