The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
Nanostructures/classification* ; Equipment and Supplies/classification*

OBJECTIVES: Effects of nanoparticles including zinc oxide nanoparticles, titanium oxide nanoparticles, and their mixtures on skin corrosion and irritation were investigated by using in vitro 3D human skin models (KeraSkin(TM)) and the results were compared to those of an in vivo animal test. METHODS: Skin models were incubated with nanoparticles for a definite time period and cell viability was measured by the 3-(4, 5-dimethylthiazol-2-yl)-2.5-diphenyltetrazolium bromide method. Skin corrosion and irritation were identified by the decreased viability based on the pre-determined threshold. RESULTS: Cell viability after exposure to nanomaterial was not decreased to the pre-determined threshold level, which was 15% after 60 minutes exposure in corrosion test and 50% after 45 minutes exposure in the irritation test. IL-1alpha release and histopathological findings support the results of cell viability test. In vivo test using rabbits also showed non-corrosive and non-irritant results. CONCLUSIONS: The findings provide the evidence that zinc oxide nanoparticles, titanium oxide nanoparticles and their mixture are 'non corrosive' and 'non-irritant' to the human skin by a globally harmonized classification system. In vivo test using animals can be replaced by an alternative in vitro test.
Animals ; Cell Survival ; Classification ; Corrosion* ; Humans ; Nanoparticles* ; Nanostructures ; Rabbits ; Skin* ; Titanium ; Zinc Oxide

OBJECTIVETo evaluate the biocompatibility of nano-silver base inorganic antibacterial agents and compare the cytotoxicity in vitro among six types of nano-silver base inorganic antibacterial agents.

METHODSFUMAT T200-4, HN300, Novaron, Kangwang, MOD and SR1000 were diluted to different concentrations, such as 100 g/L, 50 g/L, 25 g/L and 12.5 g/L. The cytotoxicity in vitro of these agents on rat's fibroblast was assayed with MTT method. And the grades of cytotoxicity were compared.

RESULTSHigh concentrations of nano-silver base inorganic antibacterial agents had cytotoxic effects on rat's fibroblasts L-929. As the concentration decreased, the cytotoxicity decreased. No cytotoxic effects were observed at or below the concentration of 25 g/L. FUMAT T200-4, Kongwang and SR1000, with the carrier of phosphate zirconium, had less cytotoxity than the others.

CONCLUSIONSNano-Silver base inorganic antibacterial agents, such as FUMAT T200-4, Kangwang, SR1000, have good biocompatibility. And they have the possibility of clinical application. The safe concentration of these agents is at or below 25 g/L.

Animals ; Anti-Bacterial Agents ; administration & dosage ; toxicity ; Cell Line ; Dose-Response Relationship, Drug ; Drug Evaluation, Preclinical ; Fibroblasts ; drug effects ; Nanostructures ; administration & dosage ; toxicity ; Rats ; Silver Compounds ; administration & dosage ; classification ; toxicity