China’s State Food and Drug Administration (SFDA) has recently issued various laws to regulate more stringently quality control in the medical market. The US Department of Health and Human Services (HHS) is also helping China improve its medical market. The HHS and China are currently in negotiation to establish memoranda of agreements on food, drugs, and medical devices.
The SFDA has already issued registration procedures for imported medical devices, to clarify the product registration process and establish evaluation of the application at each stage. From application acceptance to final approval, technical details, safety and efficacy will be checked and reviewed. The application and technical evaluation will be verified to ensure that everything has been administered properly. The SFDA has also established time limits for each stage of the product registration and approval process.
To address issues of corruption, the SFDA has also issued prohibitive rules for personnel involved in food and drug supervision. These rules prohibit such activities as direct or indirect ownership of stocks of medical-related companies, collecting any fees for lectures, and receiving gift vouchers or expensive gifts. Depending on the misdemeanor, violators may be internally reprimanded, face disciplinary action, or be turned over to the judicial authorities.
In addition to new regulations, the SFDA has also proposed systems for supervising and revising medical device industrial standards and requirements on recalls. Manufacturers failing to recall defective or unsafe medical devices will be subject to fines and possible production license seizure. Manufacturers may also face criminal charges if unrecalled products result in serious adverse events.