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.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.
Extended data:
First, commonly used medical devices
1, home health care equipment:
Pain massage equipment, home health self-inspection equipment, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene products, home first aid products, etc.
2, family health massage products:
Electric massage chair/bed, massage stick, massage hammer, massage pillow, massage cushion, massage belt, qi and blood circulation machine, foot bath device and foot massager; Hand-held massager, jacuzzi, fat-throwing belt, therapeutic instrument, plantar physiotherapy instrument, slimming belt, car cushion, kneading pad, massage chair, breast augmentation device, beauty massager, etc.
3, family medical rehabilitation equipment:
Household cervical vertebra and lumbar vertebra tractor, traction chair, physiotherapy instrument, sleeping instrument, massager, functional chair, functional bed, bracket and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.
4, home care equipment:
Family rehabilitation nursing AIDS, female pregnant and baby care products, household gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed, etc.
5, the hospital commonly used medical devices:
Trauma treatment vehicle, operating table, operating lamp, monitor, anesthesia machine, ventilator, blood cell analyzer, differentiation analyzer, enzyme-labeled instrument, washing machine, urine analyzer, ultrasonic instrument (color ultrasound, B ultrasound, etc. ), X-ray machine, nuclear magnetic resonance, etc.
Second, special rectification
On March 201April 17, China Food and Drug Administration held a press conference. From now on, the State Food and Drug Administration of the United States will focus on the five-month "five rectification" of medical devices nationwide.
Focus on rectifying five acts of false registration and declaration of medical devices, illegal production, illegal operation, expanding publicity and using unlicensed products.
The special action takes key products, key enterprises and key case clues as the breakthrough point, and severely cracks down on illegal activities through the combination of unannounced visits, centralized investigations and surprise inspections to further standardize the market order.
The State Food and Drug Administration of the United States requires that all violations of laws and regulations found in special operations be dealt with quickly, strictly and severely, and punished according to the upper limit stipulated by laws and regulations; If the circumstances are serious, the licenses of producers, operators and products shall be revoked.
Suspected of a crime, transferred to public security organs for criminal responsibility according to law; All products with potential safety hazards shall be stopped from being sold and used, and enterprises shall be ordered to recall and supervise the destruction.
References:
Baidu encyclopedia-medical equipment