Law of Medical Devices and Supplies

The SFDA shall be in charge of inspecting establishments and medical devices and supplies to ensure application of the Law, the Regulations, and the technical regulations. Inspection shall be carried out by inspectors who are appointed pursuant to a decision by the chairman of the Board; they shall be deemed preliminary criminal investigation officers with the power to: 1. detect and report medical devices and supplies in violation of this Law; and 2. take the following actions regarding the items in violation of this Law: a) seize said items and related documents, if necessary; b) collect samples for analysis; and c) recommend the destruction of items proven to be fraudulent or harmful. Destruction shall, pursuant to a decision by the SFDA and following standard technical procedures, be carried out by a committee, or more, formed for such purpose pursuant to a decision by the chairman of the Board. The violator shall incur destruction costs.