In 2017, the General Administration of Food and Drugs conscientiously implemented the “Regulations on the Supervision and Administration of Medical Devices” in accordance with the “Opinions of the State Council on Reforming the Appraisal, Evaluation and Approval System for Pharmaceutical Drug Devices” (Guofa [2015] No. 44), General Office of the Central Government General Office of the State Council The “Opinions on Deepening the Review, Approval, and System Reform to Encourage the Innovation of Drugs and Medical Devices” (Zhaozi [2017] No. 42) continued to deepen the reform of the review, approval and approval system for medical devices, and further strengthened the supervision and management of medical device registration across the country. Registered on-site inspections and clinical trial supervision and spot checks to continuously improve the quality and efficiency of medical device registration audits.
I. Medical Device Registration
(I) The gradual improvement of the regulatory system for medical device registration management
Continue to improve medical device registration management Regulation System, cooperated with the completion of the “Regulations on the Supervision and Management of Medical Devices” and issued the “Measures for the Administration of Medical Device Standards” (national food drug Supervision and Management Bureau Order No. 33), Amendment to the Administrative Measures for the Registration of In-vitro Diagnostic Reagents (Order No. 30 of the State Food and Drug Administration), medical instruments Decision on Examination and Approval Procedures for Administrative Examination and Approval (Decree No. 32 of the State Food and Drug Administration), Regulations on the Conditions and Filing of Medical Device Clinical Trial Institutions (announcement of the National Health and Family Planning Commission of the State Food and Drug Administration, 2017 No. 145), The Third Batch of Medical Device Catalogues Exempted from Clinical Trials (No. 130 of the National Food and Drug Administration Circular No. 2017). This symbolizes the gradual improvement of the regulatory system for medical device registration in China and provides for the registration of medical devices. Systematic guarantees also provide a good regulatory basis for orderly development of medical device companies.
(B) Continued in-depth reform of the examination, approval and approval system for medical devices
Actively implement measures for reviewing, reviewing and approving medical devices, improving the review, review and approval system, supervising and guiding reforms, and carrying out various reform tasks in an orderly manner.
1. Continue to do a good job in encouraging reforms related to medical device innovation, implementing the "Opinions on Reforming the Evaluation System for the Approval of Drugs and Medical Device Innovations", and organizing the National Conference on Review, Approval and Approval of Medical Device Reform to communicate the spirit of reform and interpretation. Reform policies and arrangements for key tasks. Announcement of the "Shanghai Food and Drug Administration's Announcement on Launching Pilot Programs for Medical Device Registrants System" to promote pilot programs for medical device registrants in Shanghai to ensure the effective implementation of the "Opinions" requirements. .
2. The “Measures for Communication and Communication of Medical Device Evaluation and Communication (Trial)” and “Announcement on the Release of the Administrative Measures for the Expert Consultation Committee of Medical Device Evaluation” were issued, and the review of medical devices continued to be standardized, the communication system was perfected, and the expert consultation was standardized. Continuously improve review of quality management system and system documents, continue to promote project team review system, standardize review requirements for continued registration, and improve review efficiency.
3. Promulgated the "Decision on Adjusting the Examination and Approval Procedures for the Administrative Examination and Approval of Certain Medical Devices", the examination and approval of the clinical trials for the third type of high-risk medical devices, and the approval for the continued registration approval and licensing changes for the third type of medical devices and imported medical devices in China. The examination and examination center will further simplify administration and decentralization, reduce the approval process, optimize the approval process, and increase the efficiency of examination and approval.
4. Established the Medical Device Classification Technical Committee and established a classification technology professional group. Released the new Catalogue of Medical Devices, conducted comprehensive training, strengthened policy interpretation, fully publicized and implemented the new Catalogue of Medical Devices, and made preparations for directory implementation.
5. Amendments to the “Management Criteria for the Revision of Medical Device Standards” to refine the procedures for the revision and implementation of medical device standards. Organized and carried out 86 revisions of the medical device industry standards, and reviewed and issued the “Requirements for the Use of Medical Device Quality Management Systems for Regulations”. And other 98 medical device industry standards.
6. The “Third Batch of Medical Device Catalogue Exempted from Clinical Trials” was published. Clinical trials for 153 kinds of second type medical devices, 11 types of third type medical devices, and 164 kinds of medical device products were exempted, including 116 in vitro diagnostic tests. The reagent products further expand the range of medical device catalogs that are free from clinical trials and reduce the burden on management counterparts. At the same time, they are required to publish the Basic Requirements for Exemption from Clinical Evaluation Data for Clinical Trials of In Vitro Diagnostic Reagents to guide applicants to carry out in vitro diagnostic reagents clinically. Evaluate related work.
7. Completion of allergens, flow cytometry, immunohistochemical and in situ hybridization in vitro diagnostic reagents product property and class adjustment, reasonably reduce the relevant product categories, meet the needs of clinical use.
8. The intensity of clinical test supervision and inspection has been continuously increased. Organized 2 batches of medical device clinical trial supervision and inspection, 19 registered application items of 19 companies were selected, and 38 clinical trial institutions involved were examined. There were 3 problems of authenticity. The application for registration was made without registration. The processing decision was not accepted again within one year from the date of non-registration. A total of 169 enterprises took the initiative to withdraw 261 applications for registration of medical devices. The provincial bureau launched a second type of medical device products. Clinical trial supervision and inspection.
Through on-site supervision and inspection, the legal awareness, sense of responsibility, and quality awareness of medical device registration applicants and clinical trial institutions have been strengthened, and the clinical trial process of medical devices has been strongly regulated to combat falsification and fraud. This has played a great deterrent effect.
(III) Strengthening supervision and management of medical device registration
1. Promulgated the "Notice on Doing a Good Job on Medical Device Testing" to ensure a stable and orderly registration. The "Announcement on the Use of Chinese in the Names of Registered Applicants and Recorders of Imported Medical Devices" was issued to regulate related work requirements.
2. The guidelines for the technical review of 80 medical device registrations, including the cochlear implant system, medical magnetic resonance imaging system, and hip prosthesis system, were issued, of which 52 were formulated and 28 were revised. The current development of medical devices was released. Technical guidelines for the technical review of medical device network security registration "Guiding Principles for Technical Review of Mobile Medical Device Registration" and "Guidelines for the Division of Medical Device Registration Units" effectively harmonize relevant review requirements and further standardize and guide the healthy development of relevant industries.
Second, medical device registration application acceptance
In 2017, the General Food and Drug Administration accepted registration of medical devices in accordance with its responsibilities. There were 6,834 applications for continuation of registration and licensing changes. Compared with 2016, the number of registered applications decreased by 23.4%.
(a) Overall situation
Accepted 2,457 applications for registration of Class III medical devices in the country, and 4,377 applications for registration of imported medical devices.
According to registered species, there were 4,748 applications for registration of medical devices and 2086 applications for in vitro diagnostic reagents.
According to the registration form, 1429 applications were registered for the first time, accounting for 20.9% of all medical device registration applications; 3306 applications for continued registrations, accounting for 48.4% of all applications for medical device registrations; 2,099 applications for change of licensing items were registered, accounting for all medical device registrations. 30.7% of the applications. The proportion of registration forms is shown in Figure 1.
Figure 1. Scale of registration form
(ii) Cases
1. Registration and Acceptance of Class III Medical Device in China
A total of 2,457 medical device registrations for the third category in China were accepted, a decrease of 18.3% compared with 2016. Among them, there were 1612 applications for medical device registration and 845 applications for in vitro diagnostic reagents.
From the registration form, the first registration of 796 items accounted for 32.4% of the total number of applications for registration of Class III medical devices in China; 1151 continuation of registrations, accounting for 46.8% of the total number of registration applications for Class III medical devices in China; 510 changes in licensing matters , accounting for 20.8% of the total number of registration applications for Class III medical devices in China. The distribution of registration forms is shown in Figure 2.
Figure 2. Distribution of Registration Forms for the Third Type of Registration in China
2. Registration of the second type of imported medical devices accepted
The number of imported medical device registrations of the second category was 2,057, which was 33.5% less than that of 2016. Among them, 1,283 applications for registration of medical devices and 774 applications for in vitro diagnostic reagents were registered.
From the registration form, 331 were registered for the first time, accounting for 16.1% of the total number of applications for the registration of all types of imported medical devices; 985 consecutive registrations, accounting for 47.9% of the total number of applications for the registration of all types of imported medical devices; 671 items of licensing changes , accounting for 36.0% of the total number of applications for registration of all imported Type II medical devices. The distribution of registration forms is shown in Figure 3.
Figure 3. Distribution of registration forms for the second type of registration application for import
3. Registration of third-class imported medical devices
There were a total of 2,320 registrations for imported category III medical devices, a decrease of 17.7% compared to 2016. Among them, 1,853 applications for medical device registration and 467 applications for in vitro diagnostic reagents were registered.
From the registration form, 302 were registered for the first time, accounting for 13.0% of the total number of applications for registration of all types of imported medical devices; 1170 consecutive registrations, accounting for 50.4% of the total number of applications for registration of all types of imported medical devices; 848 items of licensing changes , accounting for 36.6% of the total number of applications for registration of the third type of imported medical devices. The distribution of registration forms is shown in Figure 4.
Figure 4. Distribution of Registration Forms for the Third Type of Registration for Import
Third, review and approval of medical device registration review
In 2017, the Food and Drug Administration conducted a total of 8,579 technical reviews of medical device registration applications, a decrease of 8.1% compared to 2016. Of these, 1507 were registered for the first time, 5,218 were continued to be registered, and 1,854 license items were changed.
In 2017, the General Food and Drug Administration approved the registration of medical devices, and continued registration and licensing changes were registered for 8923. Compared with 2016, the total number of registration approvals increased by 3.1%.
In 2017, the General Food and Drug Administration had not registered 223 medical device registration applications, and the company withdrew 331 items on its own initiative.
The approval of the registration of medical devices by the General Administration of Administration in the last five years is shown in Figure 5.
Figure 5. Registered data for 2013-2017
(a) Overall situation
In 2017, the General Directorate approved 3,300 registrations of Class III medical devices in China, an increase of 13.7% compared with 2016, and 5,623 imported medical devices, a decrease of 2.3% compared with 2016.
According to the classification of registered products, there were 5475 medical devices, accounting for 61.4% of the total number of registered medical devices; 3178 in vitro diagnostic reagents, accounting for 35.6% of the total number of medical devices registered.
In accordance with the registration form, 1379 were registered for the first time, accounting for 15.5% of the total number of registered medical devices; 5614 consecutive registrations, accounting for 62.9% of the total number of registered medical devices; and 1,630 registrations for licensing changes, accounting for the total number of medical devices registered 21.6%. The proportion of registered forms is shown in Figure 6.
Figure 6. Proportional chart of registration form in 2017
(ii) Cases
1. Domestic review and approval of Class III medical devices
There are 3,300 registrations for the third type of medical devices in the country. Among them, there are 1910 medical devices and 1,390 in vitro diagnostic reagents.
In terms of registration forms, 813 registrations were conducted for the first time, accounting for 24.6% of the total number of registered medical devices in the country's third category, 1941 consecutive registrations, accounting for 58.8% of the total number of registered medical devices in the country's category III; 546 changes in licensing items, accounting for The total number of registrations for Class III medical devices in China is 16.5%. The distribution of registration forms is shown in Figure 7.
Figure 7. Distribution of registration forms for the third category of medical devices in China
2. Approval of the second type of imported medical device review and approval
2. The registration of the second type of imported medical devices was 2823. Among them, 1593 were registered for medical devices and 1230 were registered for in vitro diagnostic reagents.
In terms of registration forms, 375 registrations were conducted for the first time, accounting for 13.3% of the total number of imported medical devices of the second type; 1,769 registrations continued, accounting for 62.6% of the total number of registered medical devices of the second type of imports; 679 items of licenses were changed, accounting for All imports of 24.1% of the registered number of Type II medical devices. The distribution of registered forms is shown in Figure 8.
Figure 8. Distribution of Registration Forms for Imported Type II Medical Devices
3. Imports of Class III medical device review assessment
There are 2800 medical devices registered for category III. Among them, 2242 medical device registrations and 558 in vitro diagnostic reagents.
From the registration form, 191 were registered for the first time, accounting for 6.8% of the total number of imported medical devices of the third category; 1,904 consecutive registrations, accounting for 68.0% of the total number of imported medical devices of the third category; 705 changes in licensing matters, accounting for All imported 25.2% of the registered number of Type III medical devices. The distribution of registered forms is shown in Figure 9.
Figure 9. Distribution of registration forms for imported third-class medical devices
(III) Monthly approval status of the first registered project
In 2017, the Food and Drug Administration approved a total of 1,379 initial registrations for the first time for registered medical devices. Monthly approvals are shown in Figure 10.
Figure 10. Monthly registration of 2017 for first registration of medical device data
(IV) Analysis of specific approved varieties
In 2017, registered third domestic medical devices, in addition to in vitro diagnostic reagents, were involved in 25 sub-categories in the Catalogue of Medical Devices.
The top five registered third-tier medical devices are: medical high-molecular materials and products, implant materials and artificial organs, injection and puncture devices, medical optical instruments, instruments and endoscopic equipment, operating room, emergency room, medical treatment Room equipment and appliances.
Compared with 2016, medical polymer materials and products increased by 56.5%, jumping from the second place to the first place, while implant materials and artificial organs products dropped by 10.5% to the second place, medical optical instruments, instruments and The number of endoscopic equipment and injection and puncture equipment products was basically the same as in 2016. Although the operating room, emergency room, and examination room equipment and apparatus products increased by 24.3%, it still ranked fifth.
Figure 11. Bitmap of Registered Varieties of Registered Medical Devices in China
In 2017, registered imported medical devices, in addition to in vitro diagnostic reagents, involved 40 sub-categories of products in the Catalogue of Medical Devices.
The top five imported medical devices registered are: implanted materials and artificial organs, medical optical instruments, instruments and endoscopic equipment, dental materials, medical polymer materials and products, medical electronics equipment.
Compared with 2016, implanted materials and artificial organ products still ranked first, but they decreased by 5.1% year-on-year. Medical polymer materials and products and medical electronic equipment all decreased, while stomatologic material products increased. Larger, replacing the operating room, emergency room, clinic equipment and appliances into the top five.
Figure 12. Bitmap of imported medical device registrations
(V) Country status of imported medical devices
In 2017, the United States, Germany, Japan, the United Kingdom and South Korea registered the top five medical device registrations in China. The number of registered products accounted for approximately 73.9% of the total number of imported products in 2017, which was basically the same as in 2016.
Figure 13. Country registration chart for imported medical devices
(VI) Analysis of the province's third type of medical device provinces
From the perspective of the registration of the third domestic medical device in 2017, the production of related registered products enterprise Mainly concentrated in the coastal economy more developed provinces.
Among them, Beijing, Jiangsu, Guangdong, Shanghai, and Zhejiang are the top five provinces in terms of the number of registrations for the third type of medical devices in China, accounting for 66.7% of the total number of registrations of the third type of medical devices in China in 2017.
Figure 14. Ranking of registered provinces in the third category of medical devices in China
IV. Review, Evaluation and Approval of Products for Innovative Medical Devices
In 2017, the General Administration of Food and Drug Supervision continued to do a good job in inspecting innovative medical devices according to the “Innovative Medical Device Special Approval Procedure (Trial)” and approved the listing of some innovative medical device products.
In 2017, the General Food and Drug Administration received a total of 273 applications for special approvals for innovative medical devices, completed 323 reviews (including 2016 application items), and determined that 63 products entered the special approval channel for innovative medical devices. Approval for registration of branch-type aortic stents 12 innovative products such as membrane stents and delivery systems were launched. Among them, there were 4 active medical devices and 8 passive medical devices. The total number was increased by 2 compared to 2016.
The core technologies of these innovative products have been patented by our country's patent administrative department. The product's main working principle/mechanism of action is domestically initiated and has significant clinical application value.
(1) Branch-type aortic stent graft and delivery system (CTM 20153763241, Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd.) This product consists of a pre-installed covered stent and a delivery system. It is suitable for the treatment of thoracic diseases. The proximal end of the arterial dissection is in patients with a distance between 15mm distal to the left common carotid artery and 20mm distal to the left subclavian artery (LSA) or dissection to the left subclavian artery. The technique of this product belongs to the domestic initiative, as the first approval. The branched branched aortic stents provided for the clinical treatment of patients with thoracic aortic dissection provide a new treatment.
(b) Foldable artificial vitreous balloon (CTM 20153223296, Guangzhou TV Bo Biotechnology Co., Ltd.) This product consists of a balloon, drainage tube and diverter valve, made of medical silicone rubber, suitable for severe retina Disengagement, patients who cannot be treated with existing vitreous substitutes. This product is an innovative product independently developed in China and is an international initiative. This product can be filled in the eyes for a long time, and it solves the problem that vitreous body substitutes cannot remain in the eyes for a long time. Do not press the retina for a long time or need repetitive surgery. Avoid eyeball removal and implantation of the prosthesis.
(3) Percutaneous interventional prosthetic heart valve system (CTMC 20173460680, Hangzhou Qiming Medical Devices Co., Ltd.) This product is composed of aortic valve and delivery system. It is suitable for assessment by the heart team combined with scoring system and considers it to have symptoms. , Calcified, Severe aortic stenosis, and is not suitable for patients undergoing routine surgical replacement of the valve. This product is the first self-expanding percutaneous interventional prosthetic heart valve in China and is not suitable for patients undergoing routine surgical replacement of the valve. Brought significant clinical benefits.
(D) One-time absorbable nail intradermal stapler (CTM 20153650874, Beijing Shenghe Hengrui Medical Technology Co., Ltd.) This product is composed of absorbable staples and anastomosis, in which absorbable staples are made of L -Injection of lactide and glycolide copolymer into the skin, suitable for intra-abdominal suture of abdomen surgery. The technology of this product is the first in China. Its clinical application can achieve closure speed without changing the stitching methods commonly used by doctors. Promotes, facilitates drainage of exudates, and eliminates the need to remove staples, providing a new solution for postoperative surgical closure.
(5) Intervention of artificial biological heart valves (CTM 20153460698, Suzhou Jiecheng Medical Technology Co., Ltd.) This product consists of a self-expanding invasive valve, an apical interventional device, and a valve-loading device. It is applicable to the heart team-integrated scoring system. Patients with autologous aortic valve disease who are deemed unsuitable for surgery, including patients with aortic stenosis, and patients with aortic insufficiency. The product automatically positions the implant site without the need for rapid pacing of the heart. Treatment of patients with aortic insufficiency. This product will bring significant clinical benefit to patients with aortic stenosis and aortic valve insufficiency.
(VI) Left atrial appendage occluder system (CTM 20153770881, Xianjian Technology (Shenzhen) Co., Ltd.) This product is composed of a left atrial appendage occluder and a conveyer. The left atrial appendage occluder consists of a sealing plate. This product is mainly used in patients with non-valvular atrial fibrillation who have a high risk of stroke and long-term oral anticoagulant contraindication or anticoagulant therapy, can avoid or reduce the loss of left atrial appendage thrombus. Stroke risk. This product is the first domestically approved left atrial appendage closure product to be approved for listing, offering patients more options.
(vii) Abdominal aorta covered stent system (CTM 20153761434, Beijing Huamai Tyco Medical Devices Co., Ltd.) This product consists of a pre-installed covered stent and delivery system for subrenal abdominal aortic aneurysm and Intraluminal treatment of main iliac artery aneurysms. This product was the first domestically approved abdominal aortic stent graft system with barbed bare stent designed to increase the patient's clinical options, effectively reducing clinical treatment costs and reducing Patient's burden.
(8) Fully degradable sinus drug stent system (CTM 20153460679, Puyi (Shanghai) Biotechnology Co., Ltd.) This product consists of self-expanding fully degradable woven sinus stent, drug coating, delivery system and auxiliary tools. Suitable for patients with chronic sinusitis who have undergone functional endoscopic sinus surgery (FESS) to prevent FESS postoperative adhesions, maintain nasal patency and reduce inflammation. This product is the first approved biodegradable sinus drug stent product in the country. Helps to reduce the recurrence rate of FESS in patients with chronic sinusitis and improve the quality of life of patients.
(9) Variable-angle dual-probe single-photon emission computed tomography equipment (China National Chemical Industry Corporation, Beijing Yongxin Medical Equipment Co., Ltd.). This product consists of host computer, inspection bed, power distribution cabinet, collimator truck, acquisition and processing. Workstation, collection and control workstation composition. For nuclear medicine diagnosis of nervous system, cardiovascular, tumor. This product is the first domestic variable angle, full digital dual probe clinical universal SPECT, through the installation of multi-pinhole collimation The device enables fast, efficient and accurate image acquisition of small organs such as the heart and thyroid without the need for probe rotation.
(10) Cryogenic cryosurgery system (CMOC 20173583088, Haijieya (Beijing) Medical Devices Co., Ltd.), disposable sterile cryoablation needles (CTMC 20173583089, Haijieya (Beijing) Medical Devices Limited Company). The two products are used together to form a system. The system is mainly composed of cryoablation needles, transmission lines, cryogenic containers, high-temperature vessels, fluid electrical control systems, computer control systems, and data acquisition systems. Solid tumor cryotherapy outside the tumor cavity. The system uses a combination of ultra-low temperature freezing and high-intensity rewarming treatment mode, to achieve a breakthrough in liquid nitrogen cryogenic probe refinement technology, through the ultra-low temperature ice hockey wound surrounding the tumor, to avoid The hidden dangers of tumor cells being carried out by the ablation needle to normal tissues reduce the chance of bleeding.
(11) Implantable cardiac pacemaker (CTM 20153211570, Xianjian Technology (Shenzhen) Co., Ltd.) This product consists of an implantable pulse generator and its accessory torque wrench. It is suitable for the treatment of chronic heart rhythm. Abnormal.
The Food and Drug Administration has also approved some medical device product registrations with promising clinical applications in 2017. For example:
(1) Drug-eluting balloon catheter (CTM 20153771535, Liaoning Shengyi Biotechnology Co., Ltd.). This product is an Rx balloon dilatation catheter. The balloon surface is coated with a drug coating, suitable for primary coronary Stenosis dilation of arterial bifurcation lesions. This product is the first internationally approved drug eluting balloon catheter for coronary bifurcation lesions, providing a new treatment strategy for clinically urgent treatment of bifurcation lesions.
(B) Gene sequencing instrument (CTM 20153401605, Wuhan Huada Zhizao Technology Co., Ltd.) This product uses a combined probe-anchored polymerase sequencing technology and is used clinically for DNA derived from human samples (DNA Sequencing is performed to detect gene sequences that may cause changes in disease or disease susceptibility. The instrument is clinically limited to use with in-vitro diagnostic reagents and software approved by the State Food and Drug Administration, not for use in human genomes. Sequencing or de novo sequencing.
(3) Urine free sulfhydryl detection kit (biochemical method) (CTM 20153403176, Wuxi City Sunray Biological Products Co., Ltd.). This product is used for in vitro qualitative determination of free sulfhydryl content in urine of women aged 30 years and over. It is suitable for the auxiliary diagnosis of cervical CIN (cervical epithelial cell atypical hyperplasia). The determination of CIN grade and the definite diagnosis of tumors must rely on histological determination. This product test cannot be used as an early diagnosis or diagnosis basis for any malignant tumor. 3. Cancer screening in the general population cannot replace cervical cytology, colposcopy, and histopathology.
V. Other registration management
(I) Registration of Type II Medical Devices in China
In 2017, provincial food and drug regulatory authorities approved a total of 18,582 domestic medical device registrations of the second category, an increase of 19.5% compared to 2016. Among them, 6605 were registered for the first time, 7436 were registered consecutively, and 4,541 were registered for licensing changes.
The second category of medical device registration in the territory is shown in Figure 15.
Figure 15. Proportion of registered forms of the second type of medical devices in China
In terms of registration, Jiangsu, Guangdong, Zhejiang, Beijing, Henan, Shandong, and Shanghai have registered more domestic second-type medical devices. The specific data for registration of second-type medical devices are shown in the following table and in Figure 16.
area
Second Class Medical Device Registration in China
First registration
Continuing registration
Changes to licensing
total
Beijing
482
707
630
1819
Tianjin
158
170
185
513
Hebei
283
93
94
470
Mountain West
45
78
15
138
Inner Mongolia
17
12
1
30
Liaoning
84
153
58
295
Ji Lin
191
170
39
400
Heilongjiang
39
55
18
112
Shanghai
211
586
92
889
Jiang Su
1301
1270
675
3246
Zhejiang Jiang
619
700
636
1955
Security
59
139
157
355
Fu Jian
52
182
61
295
Jiang Xi
87
195
28
310
Mountain East
636
361
203
1200
South
365
757
222
1344
Lake North
102
201
141
444
Lake South
245
117
119
481
Guangdong
1146
919
719
2784
Guangxi
112
114
38
264
Hainan
3
7
1
11
Heavy celebration
104
109
48
261
Four Rivers
82
200
323
605
Guizhou
48
15
4
67
Cloud South
24
24
6
54
Western Tibet
3
0
0
3
Shaanxi West
65
66
11
142
Gan Su
20
17
16
53
Qing Hai
5
0
0
5
Ningxia
1
3
1
5
New Xinjiang
16
16
0
32
Total
6605
7436
4541
18582
Figure 16. Registration data for the second category of medical devices in each province
(II) Record of Type 1 Medical Devices
In 2017, the Food and Drug Administration conducted a total of 2,315 filings of imported Class I medical devices in accordance with their responsibilities, which was a decrease of 7.8% compared to 2016. The city-level food and drug regulatory authorities across the country handled the first type of domestic medical care in accordance with their responsibilities. The number of instruments filed was 13,203, an increase of 15.2% compared to 2016.
(III) Changes in registered items
In 2017, the General Food and Drug Administration handled a total of 5,181 changes in the registration of imports of Category II, Category III and Category III medical devices in accordance with their responsibilities. Compared with 2016, it decreased by 26.8%.
Among them, there were 2,100 changes in the registration of Category III medical devices within the territory, and Category II of imports, and 3,081 items for the registration of Category III medical devices.
The provincial food and drug regulatory authorities handled a total of 6,326 changes in the second category of medical device registration in China, which was 13.6% lower than in 2016.
Note: The statistics for this report are from January 1, 2017 to December 31, 2017.
