What Is The Medical Device? - ZhongXing

What is the medical device?

Medical devices refer to instruments, equipment, appliances, materials or other articles used on the human body alone or in combination, including required software; Its effects on the body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate in and play a certain auxiliary role; Its use is intended to achieve the following intended purposes:
(1) the prevention, diagnosis, treatment, monitoring and remission of diseases;
(2) diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;
(3) The study, substitution or regulation of anatomical or physiological processes;
(4) Pregnancy control.

Sort
China's current "Regulations on the supervision and Administration of medical devices" stipulates that medical devices implement three types of management.
The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management. Such as: basic surgical instruments (knives, scissors, forceps, etc.), common diagnostic instruments (stethoscope, percussion hammer, reflective equipment, etc.), medical radiation protection supplies and bandages, plaster and so on.

The establishment of the first type of medical device production and management enterprises in the provincial bureau of record, do not need to apply for a license. The production of Class I medical devices should be processed in the local municipal drug regulatory department for production registration certificate.

The second category refers to medical devices whose safety and effectiveness should be controlled. Such as: medical electronic equipment (heart, brain electrical diagnostic instruments, non-invasive monitoring instruments, etc.), B-type ultrasonic diagnostic instruments, clinical testing and analysis of some instruments, as well as thermometers, blood pressure monitors and so on.

It should be noted that the state has included some Class II medical devices into the products that can be operated without a business license. Such as: thermometer, blood pressure monitor, medical absorbent cotton, defatted gauze, health mask, home blood glucose meter, blood glucose test strip, pregnancy diagnostic test strip (early pregnancy test side test paper), condoms, etc.

The establishment of the second type of medical device production and management enterprises shall apply for the production and management enterprise license in the provincial bureau, and the production of the second type of medical devices shall apply for the production registration certificate in the provincial Bureau.
The third category refers to the implantation of the human body;

Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Such as: extracorporeal circulation and blood processing equipment, implant materials and artificial organs, disposable blood transfusion in medical polymer materials and products, infusion sets, disposable syringes in injection puncture instruments, contact lenses and so on.

The establishment of the third type of medical device production and management enterprises shall apply for the production and management enterprise license in the provincial bureau, and the production of the third type of medical device shall apply for the production registration certificate in the National Bureau.

Develop
China's medical device industry as a whole has a gap of more than 10 years with the international advanced level, However, with the development of electronic technology, computer technology and biomaterials science and the rise of biomedical engineering disciplines, China's medical device industry has obtained the theoretical basis and technical source for further development, which has led to the technological progress and innovative development of the entire industry, and embarked on the road of medical device science and technology industry. Since the 1990s, a large number of new medical devices have been successfully developed and formed a certain production capacity, which not only provides favorable supporting conditions and means for clinical medicine, but also produces good economic benefits.


Post time: May-23-2024

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