As SFDA intensifies its control over medical devices, SFDA is revamping its clinical study criteria to products that pose high risks to patients, especially when the products and the manufacturers are new in the Chinese markets. Products that are required to conduct clinical studies are:
• In-Vitro Diagnostic (IVD) Reagent Products
• Class III implantable products
Whitney Consulting will plan, manage and complete clinical study required for product registration with SFDA. Whitney Consulting follows strict ethical standards in managing each element of the study to ensure that the study is done professionally, accurately and most efficiently. |
