What is a medical device?
The "Regulations on the Supervision and Administration of Medical Devices" promulgated by the State Council on January 4, 2000 has a definition of medical devices, that is, medical devices refer to instruments, equipment, appliances, materials, or other items used on the human body alone or in combination, including the necessary The software; its use on the body surface and in the body is not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; its use is intended to achieve the following expected purposes:
Prevention, diagnosis, treatment, monitoring and alleviation of diseases;
Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;
Research, substitution, and adjustment of anatomical or physiological processes;
Pregnancy control.
How many categories are medical devices divided into? How to differentiate?
Medical devices are divided into three categories:
The first category: medical devices that can ensure their safety and effectiveness through routine management. Such as most of surgical instruments, stethoscopes, medical X-ray films, medical X-ray protective devices, automatic electrophoresis, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, band-aids, surgical gowns, surgical caps, Masks, urine collection bags, etc.
The second category: medical devices whose safety and effectiveness should be controlled. Such as clinical thermometers, sphygmomanometers, electrocardiogram diagnostic equipment, optical endoscopes, comprehensive dental treatment equipment, medical absorbent cotton, etc.
The third category: implanted in the human body; used to support life-sustaining; medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripters, invasive endoscopes, ultrasonic scalpels, laser surgery equipment, blood transfusion sets, disposable infusion sets, disposable sterile syringes, CT equipment, etc.
Data extension
How to distinguish between medicines and medical devices containing pharmaceutical ingredients?
(1) For products where drugs play the main role and medical devices play the role of auxiliary drugs (such as syringes with pre-filled drugs, etc.), they are managed as drugs.
(2) For products whose main role is played by medical devices and supplemented by drugs (such as medicated stents, catheters with antibacterial coatings, medicated condoms, medicated birth control rings, etc.), they shall be managed as medical devices.
(3) Band-aids containing antibacterial and anti-inflammatory drugs are managed according to drugs.
(4) Traditional Chinese medicine topical application products are used as traditional Chinese medicine topical application agents, and are managed according to medicines.
What requirements should medical device advertisements meet?
Medical device advertisements shall be reviewed and approved by the drug regulatory department of the people's government at or above the provincial level; without approval, they shall not be published, broadcast, distributed or posted.
The content of medical device advertisements shall be subject to the instructions for use approved by the drug regulatory authority of the State Council or the drug regulatory authority of the people's government of the province, autonomous region, or municipality directly under the Central Government.
What are the standards for medical device products?
Medical device product standards are divided into national standards, industry standards and registered product standards
What is the meaning of medical device instructions, labels and packaging marks?
The medical device manual refers to the technical document that is produced by the manufacturer and provided to the user with the product, which can cover the basic information of the safety and effectiveness of the product and is used to guide the correct installation, commissioning, operation, use, maintenance, and maintenance.
Medical device labels refer to text descriptions, graphics, and symbols attached to medical devices or packaging to identify product features.
The medical device packaging label refers to the textual description, graphics, and symbols that reflect the main technical characteristics of the medical device marked on the packaging.
What are medical device adverse events?
Medical device adverse events refer to any harmful events that have occurred or may occur that are not related to the expected use effect of the medical device under normal use of a qualified medical device that has been approved for the market.
Which are serious injuries from medical device adverse events?
There are 4 types of medical device adverse events that are serious injuries:
Cause a life-threatening illness or injury;
Permanent damage to body function;
Permanent damage to the body structure;
Drugs or surgical intervention are required to avoid the above-mentioned permanent exercise injuries and permanent damages.
Are all equipment suitable for home use?
The state implements classified management of medical devices:
The first category refers to routine management, that is, devices that do not touch the human body or only touch the skin and mucous membranes, such as sphygmomanometers and clinical thermometers.
The second category refers to medical devices whose safety and effectiveness should be controlled, such as x-ray machines.
The third category refers to medical devices that are implanted in the human body to support and maintain life and are potentially dangerous to the human body. The safety and effectiveness of the medical devices must be strictly controlled, such as various infusion sets, syringes, pacemakers, and ventilators. Wait.
From the above, it can be seen that the second and third categories of medical devices should not be purchased for household use, because after all, such medical devices have greater potential dangers, and the requirements for use are strict and require a high degree of caution. In addition, there are currently some new medical device products that need to be tried, or products in the development stage or medical devices used in laboratories, which will be temporarily allowed to be used in designated hospitals under "unlicensed" status. Obviously, medical equipment is not suitable for general consumers to buy and use blindly.