What is a class of medical devices

Medical device means an instrument, apparatus, appliance, material or other article, including the required software, used alone or in combination in the human body; whose use on the surface of the human body and in the body is not obtained by pharmacological, immunological or metabolic means, but which may be involved in these means and play a certain supporting role; and whose use is intended to achieve the following intended purposes:

(1) prevention, diagnosis, treatment, monitoring and alleviation of diseases;

(2) diagnosis, treatment, monitoring, alleviation and compensation of injury or disability;

(3) diagnosis, treatment, monitoring, alleviation and compensation of injury or disability (i) the prevention, diagnosis, treatment, guardianship, and mitigation of disease;

(ii) the diagnosis, treatment, guardianship, mitigation, and compensation of injury or disability;

(iii) the study, substitution, and regulation of anatomical or physiological processes;

(iv) the control of pregnancy.

Article V. The State shall implement classification and management of medical devices.

Class I refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.

The production of Class I medical devices, by the municipal people's government of the municipal level drug supervision and management department for examination and approval, and issue a certificate of registration of product production.