2015 Annual Medical Device Registration Work Report of the General Administration

Source: CFDA 2016-4-5 in 2015, the State Food and Drug Administration (hereinafter referred to as the food and Drug Administration) took the maintenance and promotion of public health as its own responsibility, and thoroughly implemented the regulations on the supervision and administration of medical devices (Order No 650 of the State Council) and the opinions of the State Council on the reform of the review and approval system of medical devices (Guo Fa [) 2015] No 44), promote the reform of medical device review and approval system, standardize and guide the national medical device registration, and improve the quality and efficiency of medical device registration and review I The registration of medical devices shall be in accordance with the regulations on the supervision and administration of medical devices The food and drug administration shall be responsible for the acceptance, technical evaluation and administrative examination and approval of the registration of class III and imported class II and class III medical devices The provincial food and drug administration shall be responsible for the registration acceptance, technical review and administrative examination and approval of class II medical devices in China (1) to improve the registration management system of medical devices, 16 rules and normative documents have been formulated and issued, including the classification rules of medical devices, the naming rules of general names of medical devices, the technical guidelines for clinical evaluation of medical devices, and the verification procedures for the registration quality management system of class III medical devices in China It further improved the medical device registration management system, standardized the technical review, registration verification and other related work of medical devices, and provided a good legal basis for the registration management of food and drug regulatory authorities at all levels and the orderly implementation of registration and application of administrative counterparts (II) promote the reform of medical device review and approval system in 2015, the medical device technical review center of the food and Drug Administration studied and formulated the implementation plan for the reform of the review mechanism, further strengthened the pre post training and continuing education training of reviewers, and improved the comprehensive quality of reviewers The food and Drug Administration reviewed and issued 28 national standards such as "active implantable medical devices" and 90 industry standards such as "hemodialysis and related treatment water" The work plan for the reform of medical device classification management was formulated, the Technical Committee for medical device classification was established, and the revision of medical device classification catalog was started Continue to review innovative medical devices in accordance with the special approval procedure for innovative medical devices (Trial), and promote the innovation and development of the medical device industry (III) carry out assessment and evaluation of provincial medical device review and approval ability The State Food and Drug Administration issued the guiding opinions on strengthening the construction of technical evaluation capacity of provincial medical devices, organized the formulation of the work plan for the evaluation and evaluation of the evaluation and approval capacity of provincial medical devices, organized the pilot evaluation of the evaluation and approval capacity of provincial medical devices, and promoted the registration management level and quality of provincial food and drug administration The promotion of (IV) strengthen the basic work of registration, the food and Drug Administration continued to promote the preparation and revision of the guiding principles for the technical review of medical device registration, and issued 12 guiding principles for product registration such as "hepatitis B virus genotyping test reagent" and 2 guiding principles for the preparation of instructions such as "soft hydrophilic contact lens" By the end of 2015, 125 guiding principles for technical review of medical device registration had been issued Through the release of the guiding principles, we further unified the national scale of the registration of specific medical devices, and also provided effective guidance for the management of the registration of the counterpart On September 10, 2015, the State Food and Drug Administration launched the first type of medical device registration management filing subsystem on line, standardizing and guiding the first type of medical device filing work in various regions On December 20, 2015, the new medical device registration management system of the food and drug administration was launched online to standardize the requirements of registration electronic declaration and improve the informatization level and work efficiency of the review work II Acceptance of medical device registration applications in 2015, the food and Drug Administration accepted 9396 registration applications for medical devices (in vitro diagnostic reagents), including 2402 applications for first registration, 5105 applications for continuation of registration, 1889 applications for change of licensing matters, a decrease of 6.7% over 2014 (I) overall situation in 2015, 3921 applications for registration of class III medical devices (in vitro diagnostic reagents) and 5475 applications for registration of imported medical devices (in vitro diagnostic reagents) were accepted According to the registered varieties, there are 5509 applications for medical devices registration and 3887 applications for in vitro diagnostic reagents registration According to the registration form, there are 2402 applications for first registration, 5105 applications for continued registration and 1889 applications for change of licensing matters Figure 1 Proportion of registration form (2) sub item 1 Acceptance of class III medical device registration in China in 2015, 3921 items of class III medical device registration acceptance in China Among them, 2219 applications for registration of medical devices and 1702 applications for registration of in vitro diagnostic reagents In terms of registration form, 1562 applications for first registration, accounting for 40%; 1635 applications for continued registration, accounting for 42%; 724 applications for change of registration of licensing matters, accounting for 18% 2 Registration and acceptance of imported class II medical devices in 2015, there were 3024 registration and acceptance of imported class II medical devices There are 1339 applications for medical device registration and 1685 applications for in vitro diagnostic reagent registration In terms of registration form, 499 applications for first registration, accounting for 17%; 1895 applications for continuing registration, accounting for 63%; and 20% applications for changing registration of licensing matters 3 Registration and acceptance of imported class III medical devices in 2015, there were 2451 registration and acceptance of imported class III medical devices There are 1951 applications for medical device registration and 500 applications for in vitro diagnostic reagent registration In terms of registration form, there are 341 applications for first registration, accounting for 14%; 1575 applications for continuing registration, accounting for 64%; 535 applications for changing registration of licensing matters, accounting for 22% Figure 2 Distribution of registration forms of category III, imported category II and category III in China To sum up, the number of applications for the first registration of category III IVD reagents in China is more than that for the continued registration, while the number of applications for the continued registration of category III medical devices, imported medical devices and IVD reagents in China is more than that for the first registration However, whether it is the third category of domestic or imported medical devices, the application for change of registration of licensing matters is roughly the same, all of which are about 20% III review and approval of medical device registration (I) overall situation in 2015, the food and Drug Administration approved a total of 7530 medical device registrations Among them, 2707 were registered for the first time, 4072 were registered for renewal, and 751 were registered for change of licensing matters Compared with 2013 and 2014, the total number of registration approvals decreased slightly In 2015, food and drug administration refused to register 1297 medical device registration applications Figure 3 2013-2015 annual registration data chart includes 2730 domestic class III medical devices (including in vitro diagnostic reagents) and 4800 imported class II and class III medical devices (including in vitro diagnostic reagents) Figure 4 The registration data of domestic and imported medical devices in 2015 are divided according to the registered varieties, including 4823 medical devices and 2707 in vitro diagnostic reagents, with a ratio of about 6:4 According to the registration form, the specific proportion distribution is shown in the figure below Figure 5 Proportion chart of registration form (2) itemized statistics 1 334 items were registered for the first time, 1074 items were registered continuously, and 86 items were registered for change of licensing items 514 items were registered for the first time, 479 items were renewed and 243 items were changed Figure 6 The proportion of the registration forms of the third class medical devices and in vitro diagnostic reagents in China Figure 2 1533 items of the first registration of imported medical devices (in vitro diagnostic reagents), 1640 items of continued registration, 156 items of change registration of licensing 326 items of imported in vitro diagnostic reagents were registered for the first time, 879 items were registered continuously, and 266 items were registered for change of licensing items Figure 7 Proportion chart of registration forms of imported medical devices and in vitro diagnostic reagents in summary, from the overall situation of the approved products, the number of continuous registration approval is more than the number of first registration approval, and for the third type of in vitro diagnostic reagents in China, the number of first registration is more than the number of continuous registration 3 In terms of the first and continued registration data, the in vitro diagnostic reagents have a significant advantage in the corresponding registration Among them, in the third category of medical devices in China, the number of in vitro diagnostic reagents accounted for 45% of the total registration rate, while in the imported medical devices, in vitro diagnostic reagents accounted for 31% In 2015, in addition to in vitro diagnostic reagents, the class III medical devices registered in China involved products in 26 subdirectories of the medical device classification catalog The top five domestic class III medical devices registered are: medical polymer materials and products, implant materials and artificial organs, injection and puncture devices, medical optical devices, instruments and endoscope equipment, and intervention devices Figure 8 Ranking chart of the third type of medical devices registered in China in 2015, in addition to in vitro diagnostic reagents, the registered imported medical devices were involved in 41 subdirectories of the medical device classification catalog The top five registered imported medical devices are mainly medical optical devices, instruments and endoscope equipment, implant materials and artificial organs, dental materials, medical electronic instruments and equipment, medical polymer materials and products Figure 9 Ranking of registered varieties of imported medical devices Figure 4 Country analysis of imported medical devices in 2015, the United States, Germany, Japan, the United Kingdom and South Korea ranked the top five in the number of registered medical devices in China, accounting for about 67% of the total number of first and continued registration of imported products in 2015 Figure 10 National registration ranking of imported medical devices Figure 5 Analysis of the third category medical device provinces in China from the registration of the third category medical device in 2015, the relevant registered product manufacturers are mainly concentrated in the provinces with more developed coastal economy Figure 11 Province registration distribution of the third type of medical devices in China Among them, Beijing, Jiangsu, Guangdong, Shanghai and Shandong are the provinces with the largest number of the third type of medical devices in China, accounting for 67% of the first and continued registration of the third type of medical devices in 2015 Figure 12 Ranking of the third type of medical device registration provinces in China Figure 4 Review and approval of innovative medical devices and other products in 2015, the food and Drug Administration continued to do a good job in the review of innovative medical devices in accordance with the special approval procedure for innovative medical devices (Trial), and approved the listing of some innovative medical devices In 2015, the State Food and drug administration received 157 special approval applications for innovative medical devices