Production of medical equipment does not meet the standard how to correctly identified?

1. The perpetrator of the production and sale of substandard medical equipment is the premise of this crime. The so-called non-standard medical equipment, refers to the perpetrator of the production or sale of dedicated to the prevention, diagnosis, treatment of disease, regulation of human physiological function or replacement of human organs, instruments, equipment, devices, appliances and their auxiliary materials, does not comply with the national standards to protect human health standards, industry standards. No national standards, industry standards for medical devices, registered product standards can be regarded as "safeguarding human health industry standards".

2. According to Article 145 of the Criminal Law, this crime was originally a result of the crime, that is, only in the case of serious harm to human health can be constituted. However, the Amendment (IV) to the Criminal Law of the People's Republic of China promulgated on December 28, 2002, has modified this crime into a dangerous crime, i.e., as long as the perpetrator produces or sells substandard medical devices and medical sanitary materials, which are sufficient to seriously endanger human health, this crime can be constituted.

3. Medical institutions or individuals, who know or should know that they are medical devices or medical hygiene materials that do not meet the national or industrial standards for safeguarding human health and purchase or use them, causing serious harm to human health, shall be convicted and punished for the crime of selling substandard medical devices.

4. The production and sale of medical devices that do not meet the standard does not constitute this crime, but if the sales amount reaches more than 50,000 yuan or the value of the goods reaches more than three times the standard amount of the sales amount as mentioned above, the person shall be convicted and punished for the crime of production and sale of shoddy products.