1. Look at the identification on the product nameplate?
2. "Medical Device Product Registration Management Measures" have provisions
The following products are included in Class III:?
1. All products implanted in the human body (regardless of the use of biological materials);? 2. Radiotherapy equipment;? 3. Respiratory anesthesia equipment;? 4. Extracorporeal circulation equipment;? 5. X-ray CT, MRI, ultrasound CT, positron CT, single photon CT;? 6. Contact with in vivo blood or return to the body of blood polymer materials, medical supplies, ultrasound imaging equipment with interventional devices with implanted products;? 7. Oxygen therapy chambers, infant incubators are regarded as life support products;? 8 cardiac and vascular endoscopes, radioactive sources of radiation diagnostic equipment as potentially hazardous products;? 9. Simulation-type sex aids as potentially dangerous special cases.
Class II:
Article 5
This "catalog" will be divided into two parts of medical devices, namely, apparatus and instruments, equipment and materials. Wherein the apparatus class? This Catalog only lists the first category of apparatus and the third category of apparatus, the second category of apparatus is not listed. Belonging to the 6801-6819 categories of products, except for implantation for human use, disposable polymer products, new varieties, energy products, are naturally categorized into the second category. 6846 - Functional aids - Hearing aids belong to the second category.
(It is similar to the electrocardiogram and so on)
Class I:
Inside the catalog
(Note: Due to the uncertainty of the components inside the various surgical kits, the catalog does not contain this class of products. Where surgical kits contain Class III medical devices, they are managed as Class III products; where they contain only Class II and Class I medical devices, they are managed as Class II products; and where they contain only Class I medical devices, they are managed as Class I products.)