Medical device regulations refer to normative documents issued by the State Council and China Food and Drug Administration, and are programmatic documents for the management of medical device industry, such as Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Medical Device Registration, Measures for the Supervision and Administration of Medical Device Production, and Measures for the Administration of Medical Device Instructions and Labels. , as well as the registration methods and management methods formulated by provinces and cities according to regional conditions, are in line with the provisions promulgated by the State Administration.
Standards are the requirements of medical device products, including national standards and special standards, and are also divided into mandatory standards and recommended standards.
System refers to the internal quality management system of medical device enterprises. According to the requirements of the Regulations on the Supervision and Administration of Medical Devices, medical device enterprises should establish a quality management system, and the general system standard in China is YY/T0287-2003.
Review or review, review generally refers to the process of sending the submitted technical data to the review center for review during the product registration process.