I. Definition
A “medical device” refers to any instrument, device, apparatus, in vitro diagnostic reagent or calibrator, material or any other similar or related article used directly or indirectly for human body, including any required computer software; it achieves its intended action by physical means, not by pharmacological, immunological or metabolic means, which may only assist in its function.
2017 Regulations on Supervision and Administration of Medical Devices (State Council Decree No. 680)
II. Classification
In the supervision and administration of medical devices, in vitro diagnostic reagents are taken out for separate supervision and administration because of their different product requirements.
(I) Medical Devices (Non in vitro diagnostic reagents, mainly including passive and active medical devices)
According to Article 4 of the Regulations on Supervision and Administration of Medical Devices (State Council Decree No. 680), the medical devices are subject to classified management according to their risk level in China. The medical devices ("MD") are divided into three categories according to their risk level:
Category I: Low-risk MDs, which only require regular management to ensure their safety and effectiveness.
Category II: Moderate-risk MDs, which require strict control and management to ensure their safety and effectiveness.
Category III: High-risk MDs, which require strict control and management and special measures to ensure their safety and effectiveness.
(II). In Vitro Diagnostic Reagents
According to the Measures for the Administration of Registration of In-Vitro Diagnostic Reagents, the in vitro diagnostic reagents are classified into three categories according to their risk level.
1. Category I
1) Microbial culture medium (not for microbial identification and drug susceptibility testing);
2) Products for sample treatment, such as hemolytic agents, diluent, stain solution, etc.
2. Category II
Except for those clearly classified as Category I and III, the remaining products are Class II, including:
1) Reagents for protein assay;
2) Reagents for glucose assay;
3) Reagents for hormone assay;
4) Reagents for enzyme assay;
5) Reagents for lipid assay;
6) Reagents for vitamin assay;
7) Reagents for inorganic ion testing;
8) Reagents for drug and drug metabolite testing;
9) Reagents for autoantibody testing;
10) Reagents for microbial identification or drug susceptibility testing;
11) Reagents for testing indexes of other physiological, biochemical or immunologic functions.
3. Category III
1) Reagents related to testing of pathogenic pathogen antigen, antibody and nucleic acids;
2) Reagents related to blood grouping and tissue matching;
3) Reagents related to human genetic testing;
4) Reagents related to genetic diseases;
5) Reagents related to testing of narcotic, psychotropic and medicinal toxic drugs;
6) Reagents related to testing of therapeutic drug targets;
7) Reagents related to tumor marker testing; and
8) Reagents related to allergic reaction (allergen).
