MEDICAL DEVICES INDUSTRY ASSESSMENT I. （医疗器械行业评价我。）.pdfVIP

MEDICAL DEVICES INDUSTRY ASSESSMENT I. Background of Industry A. Industry Definition : The United States (U.S.) medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patients in healthcare systems worldwide. Medical devices differ from drugs in that they do not achieve their intended use through chemical reaction and are not metabolized in the body. Medical devices range in nature and complexity from simple tongue depressors and bandages to complex programmable pacemakers and sophisticated imaging systems. B. Key Products : The key products that comprise the medical devices industry, include, surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, in-vitro diagnostic substances, irradiation apparatus, dental and ophthalmic goods. C. NAICS Codes : The following North American Industry Classification System (NAICS) codes comprise the medical devices industry that is covered by the Office of Health and Consumer Goods (OHCG): 325413 In-Vitro Diagnostic Substances Manufacturing 334510 Electro-medical and Electrotherapeutic Apparatus Manufacturing 334517 Irradiation Apparatus Manufacturing 339112 Surgical and Medical Instrument Manufacturing 339113 Surgical Appliances and Supplies Manufacturing 339114 Dental Equipment and Supplies Manufacturing 339115 Ophthalmic Goods Manufacturing • In-vitro diagnostic substances (IVDs) (NAIC 325413); about 10 percent of the total measured by value of shipment (VOS) for medical devices include chemical, biological or radioactive substances used for diagnostic tests performed in test tubes, Petri dishes, machines, and other diagnostic test-type devices. • Electro-medical