2016 medical device registration report

Source: CFDA 2017-03-28 In 2016, the State Food and Drug Administration (hereinafter referred to as the food and Drug Administration) implemented the regulations on the supervision and administration of medical devices, continued to further promote the reform of the review and approval system of medical devices in accordance with the opinions of the State Council on the reform of the review and approval system of medical devices (GF [2015] No 44), and further strengthened the registration of medical devices nationwide Work supervision and management, strengthen on-site verification and authenticity spot check, and continuously improve the quality and efficiency of medical device registration review and approval 1、 Registration of medical devices (I) the regulatory system of medical device registration has gradually improved and issued the code for quality management of clinical trials of medical devices (State Food and Drug Administration) Order No 25 of the health and Family Planning Commission of the people's Republic of China, rules for the nomenclature of general names of medical devices (Order No 19 of the State Food and Drug Administration), priority approval procedures for medical devices (Announcement No 168 of the State Food and Drug Administration in 2016), catalog of class II medical devices exempt from clinical trials (the second batch) and exempt from clinical trials Catalog of class III medical devices for clinical trials (the second batch) (Circular of the State Food and drug administration, 2016, No 133) The preparation and revision of the above regulations and normative documents marks the gradual improvement of the regulatory system of medical device registration in China, which provides a system guarantee for the registration and management of medical devices, and also provides a good regulatory basis for the orderly development of the registration and application of medical device enterprises （2） In 2016, the reform of the medical device review and approval system continued to deepen The food and Drug Administration established the medical device review and approval reform office, formulated the 2016 reform task breakdown table, supervised and guided the reform work, and orderly promoted various reform tasks 1 The technical evaluation center of medical devices of the food and drug administration shall establish and improve the evaluation quality management system and system documents, issue and implement the quality management specifications for registration and evaluation of medical devices, expand the scope of project team evaluation, separate queues for application for continued registration, standardize the review requirements for continued registration, improve the communication and exchange system, standardize expert consultation, and improve the evaluation efficiency 2 According to the requirements of review and approval reform, promote the reform of classification management, complete the catalogue of medical device classification (Draft for comments), open for comments, and prepare to establish all professional groups of the technical committee of medical device classification 3 Actively promote the preparation and revision of medical device standards, and determine medical electrical equipment Part 2: special requirements for basic safety and basic performance of light ion beam medical electrical equipment and other 106 medical device industry standard plan projects, reviewed and issued 250 medical device industry standards such as surgical implants and disinfection equipment, including 48 mandatory standards, 202 recommended standards, and issued 1 standard modification sheet 4 The second batch of medical devices exempt from clinical trials was released 267 kinds of second class medical devices and 92 kinds of third class medical devices were exempted from clinical trials, totaling 359 kinds of medical device products, including 15 kinds of in vitro diagnostic reagent products, which was also the first time that in vitro diagnostic reagent products were listed in the exempt from clinical trials 5 The spot check on the authenticity of clinical trials is increasing Organize the supervision and inspection of two batches of clinical trials of medical devices, select 20 registration application items from 20 enterprises, check 40 clinical trial institutions involved, and make the decision of not registering the registration of 8 registration applications with authenticity problems and not accepting them again within one year from the date of not registering A total of 122 enterprises voluntarily withdrew 263 medical device registration applications The Provincial Bureau also took the initiative to carry out the supervision and spot check of the clinical trials of the second type of medical devices Through on-site supervision and inspection, the legal awareness, integrity awareness, responsibility awareness and quality awareness of the applicant and clinical trial institutions were strengthened, the clinical trial process of medical devices was effectively standardized, and fraud was combated, which played a huge deterrent role 6 Each provincial food and drug regulatory department shall continuously strengthen the promotion of provincial review and approval ability and vigorously promote the reform of review and approval system Some provincial bureaus have issued preferential Approval Measures for innovation and other special class II medical devices, optimized and simplified the registration process of class II medical devices, and 14 provinces have implemented registration fee system 7 On December 29, 2016, the decision on adjusting the examination and approval procedures for administrative examination and approval of some medical devices (Draft for public comment) was completed and opinions were publicly solicited （3） In 2016, we strengthened the supervision and management of medical device registration, formulated and revised 52 guiding principles for technical review of medical device registration, including magnetic therapy products, dental implants (Systems), absorbable sutures, etc., 30 of which were formulated and 22 were revised In view of the actual situation of the development of medical devices, the release of "technical guidelines for network security of medical devices" effectively unified the relevant review requirements, and improved the level of product safety and effectiveness review At the same time, 33 preparation projects of guiding principles for technical review of medical device registration were deployed Continue to strengthen the assessment and evaluation of provincial medical device review and approval ability, modify and improve the assessment and evaluation indicators of review and approval ability, and organize on-site assessment and evaluation of 10 provincial bureaus on the basis of provincial self-examination In the on-site assessment and evaluation, files are selected for on-site review, and common problems are analyzed and summarized to effectively promote the improvement of medical device registration management level of provincial food and drug regulatory authorities 2、 Acceptance of medical device registration applications in 2016, the food and Drug Administration accepted a total of 8920 applications for medical device registration, renewal registration and change of licensing matters, a decrease of 5.1% compared with 2015 （1） As a whole, in 2016, we accepted 3007 domestic class III medical device registration applications and 5913 imported medical device registration applications According to the registered varieties, there are 5920 applications for medical devices registration and 3000 applications for in vitro diagnostic reagents registration According to the form of registration, 1612 applications for first registration account for 18% of all applications for registration, 5402 applications for continuing registration account for 61% of all applications for registration, and 1906 applications for change of registration of licensing matters account for 21% of all applications for registration See Figure 1 for the proportion of registration forms Figure 1 Proportion of registration forms (2) sub items 1 Acceptance of domestic class III medical device registration in 2016, a total of 3007 domestic class III medical device registration acceptance, a decrease of 23% compared with 2015 Among them, there are 1899 applications for medical device registration and 1108 applications for in vitro diagnostic reagent registration In terms of registration form, 864 items of first registration accounted for 29% of the total number of applications for registration of class III medical devices in China, 1622 items of continued registration accounted for 54% of the total number of applications for registration, and 521 items of change in licensing accounted for 17% of the total number of applications for registration See Figure 2 for the distribution of registration forms Figure 2 Distribution of registration forms of class III registration applications in China Figure 2 Registration acceptance of imported class II medical devices in 2016, there were 3095 registration acceptance of imported class II medical devices, an increase of 2% compared with 2015 There are 1690 applications for medical device registration and 1405 applications for in vitro diagnostic reagent registration In terms of registration form, 449 items of first registration accounted for 15% of the total number of applications for registration of imported class II medical devices, 2021 items of continued registration accounted for 65% of the total number of applications for registration, and 625 items of change in licensing accounted for 20% of the total number of applications for registration See Figure 3 for the distribution of registration forms Figure 3 Distribution of application forms for registration of imported class II medical devices 3 Acceptance of registration of imported class III medical devices in 2016, there were 2818 items of acceptance of registration of imported class III medical devices, an increase of 15% compared with 2015 There are 2331 applications for medical device registration and 487 applications for in vitro diagnostic reagent registration In terms of registration form, 299 first registrations account for 11% of the total number of applications for registration of imported class III medical devices, 1759 continuing registrations account for 63% of the total number of applications for registration, and 760 changes in licensing matters account for 16% of the total number of applications for registration See Figure 4 for the distribution of registration forms Figure 4 Distribution of registration forms of imported class III registration applications 3 Review and approval of medical device registration in 2016, the food and Drug Administration completed 9336 technical reviews of medical device registration applications, an increase of 0.25% compared with 2015 Among them, 2427 were registered for the first time, 5276 were registered for renewal, and 1633 were changed in licensing matters By the end of 2016, there were 5598 applications in review status, of which 2247 were in the status of sending supplementary material notice to be supplemented In 2016, the State Food and Drug Administration approved 8653 medical device registration, renewal registration and change registration of licensing matters Compared with 2015, the total number of registration approvals increased by 14.9% In 2016, the food and drug administration refused to register 338 medical device registration applications, and the enterprise withdrew 310 of them See Figure 5 for the registration of medical devices approved by the General Administration in recent four years Figure 5 Registration data of 2013-2016 (I) overall situation in 2016, the State Administration approved 2902 domestic class III medical device registrations, an increase of 6% compared with 2015, and 5751 imported medical devices, an increase of 20% compared with 2015 According to the registered varieties, there are 5506 medical devices and 3147 in vitro diagnostic reagents, the ratio of which is about 7:4 According to the registration pattern, the first registration accounted for 23% of the total registration, the renewal registration for 5221 accounts for 60% of the total registration, and the change registration for licensing matters for 1466 accounts for 17% of the total registration See Figure 6 for the proportion of registration forms Figure 6 The proportion of registration forms in 2016 (II) sub item 1 Review and approval of class III medical devices in China 2902 class III medical devices in 2016 Among them, there are 1661 medical devices and 1241 in vitro diagnostic reagents In terms of registration form, 929 items of first registration accounted for 32% of the total number of applications for registration of class III medical devices in China, 1510 items of continued registration accounted for 52% of the total number of applications for registration, and 463 items of license change accounted for 16% of the total number of applications for registration See Figure 7 for the distribution of registration forms Figure 7 Distribution of registration forms of category III medical devices in China 2 Review and approval of imported category II medical devices in 2016, 3083 items of imported category II medical devices were registered Among them, 1535 were registered for medical devices and 1548 for in vitro diagnostic reagents In terms of registration form, 444 items of first registration accounted for 14% of the total number of applications for registration of imported class II medical devices, 2077 items of continued registration accounted for 68% of the total number of applications for registration, and 562 items of change in licensing accounted for 18% of the total number of applications for registration See Figure 8 for the distribution of registration forms Figure 8 Distribution of registration forms of imported class II medical devices Figure 3 Review and approval of imported class III medical devices in 2016, 2668 imported class III medical devices were registered Among them, 2255 were registered for medical devices and 413 for in vitro diagnostic reagents In terms of registration form, 593 items of first registration accounted for 22% of the total number of applications for registration of imported class II medical devices, 1634 items of continued registration accounted for 61% of the total number of applications for registration, and 441 items of change in licensing accounted for 17% of the total number of applications for registration See Figure 9 for the distribution of registration forms Figure 9 Distribution of registration forms of imported class III medical devices (3) monthly approval of the first registered items in 2016, the food and Drug Administration approved a total of 1966 first registered medical devices, and the monthly approval is shown in Figure 10 Figure 10 Data chart of the first registered medical device approved monthly in 2016