How to classify medical devices?

Medical devices are divided into three categories:

The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.

Magnetic vibration equipment belongs to the third kind of medical instruments.

The second category of medical devices is:

X-ray filming machine, B-ultrasound, microscope, biochemical instrument, etc.

The third category of medical devices is:

Implantable pacemaker, extracorporeal shock wave lithotriptor, patient invasive monitoring system, intraocular lens, invasive endoscope, ultrasonic scalpel, color ultrasonic imaging equipment, laser surgery equipment, high-frequency electrotome, microwave therapeutic instrument, medical magnetic resonance imaging equipment, etc.

Extended data

Requirements for Class II medical devices:

(a) the person in charge of the enterprise should have a technical secondary school degree or above or a junior title.

(two) the person in charge of the quality inspection institution shall have a college degree or above or an intermediate title or above.

(three) the engineering and technical personnel with junior titles or above in the enterprise shall account for the corresponding proportion of the total number of employees.

(four) enterprises should have the corresponding product quality inspection ability.

(five) there should be a place and environment for production and storage that match the products and scale of production.

(6) Having corresponding production equipment.

(seven) the enterprise shall collect and keep the laws, regulations, rules and related technical standards related to the production and operation of the enterprise.

(eight) the production of sterile medical devices should have a production site that meets the requirements.

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