Source: State Drug Administration website

 In recent years, the State Drug Administration to fully implement the Party Central Committee and State Council to deepen the medical device review and approval system reform requirements, and actively promote innovative medical devices, national key research and development programs and major scientific and technological special medical devices on the market, to promote industrial innovation and high-quality development, to better meet the needs of patients' health.

On September 26, 2022, the State Drug Administration approved the application for registration of the innovative product “Proton Therapy System” produced by Shanghai Aipuqiang Particle Equipment Co. This product is a key project supported by the “Digital Diagnostic and Treatment Equipment Special Project” of the Key R&D Program of the Ministry of Science and Technology during the “13th Five-Year Plan” period, and it is also the first domestically-made proton therapy system approved for marketing in China. The approval of this product marks another step in the localization of China's high-end medical equipment, which is of great significance in enhancing China's medical oncology diagnosis and treatment means and level.

 The product consists of two parts: gas pedal system and treatment system. Among them, the gas pedal system includes injector system, low-energy transmission system, main gas pedal system, high-energy beam current transmission system and auxiliary electrical system, and the treatment system includes fixed-beam treatment system, 180°rotating beam treatment system and treatment planning system. The product provides proton beams for radiation therapy, which can reduce the dose to surrounding normal tissues, especially the dose to tissues behind the target area, while achieving high dose to the tumor site. It is suitable for the treatment of systemic solid malignant tumors and certain benign diseases, and the specific indications should be determined by clinicians in accordance with the actual situation.

 Users should use the product in strict accordance with the approved scope of application of the product, and at the same time should strictly comply with the diagnostic and therapeutic norms of the health and wellness department.

 In the process of registration and declaration of the product, the State Drug Administration, in accordance with the principle of “early intervention, specialists, full guidance, scientific approval”, under the premise of not lowering the standards and not reducing the procedures, actively communicate, coordinate with various parties, increase the guidance of product registration and declaration, accelerate the review and approval process, and promote the product to market as soon as possible to meet the needs of patients using high quality products on the basis of ensuring safety and effectiveness. The products will be listed as soon as possible to meet the needs of patients using high-level medical devices.

Innovative Medical Devices Approved by State Drug Administration (SDA)

No.

Product Name

Manufacturer

Registration No.

1

Gene Sequencer

Shenzhen Huayinkang Gene Technology Co.

National Instrument Registration 20143402171

2

Nucleic acid analyzer for microfluidic chip with constant temperature amplification

Boao Bio Group Co.

National Instrumentation Note Approval 20153400580

3

Dual-channel implantable deep brain electrical stimulation pulse generator kit

Suzhou Jingyu Medical Instrument Co.

National Instrumentation Certificate 20153210970

4

Implantable deep brain electrical stimulation electrode lead kit

Suzhou Jingyu Medical Equipment Co.

National Instruments Note 20153210971

5

Implantable deep brain electrical stimulation extension lead kit

Suzhou Jingyu Medical Equipment Co.

National Instrumentation Certificate 20153210972

6

MTHFR C677T Gene Test Kit(PCR-Gold Magnetic Particle Chromatography)

Xi'an Gold Magnetic Nano Biotechnology Co.

National Instrument 20153401148

7

Decellularized corneal stroma

Shenzhen Ainier Cornea Engineering Co.

National Instrument 20153460581

8

Septin9 gene methylation detection kit (PCR fluorescent probe method)

Baoer Cheng (Beijing) Technology Co.

National Instruments Note 20153401481

9

Mammography equipment

Koning (Tianjin) Medical Equipment Co.

National Instruments license 20153302052

10

Motor neuron survival gene 1 (SMN1) exon deletion detection kit (fluorescence quantitative PCR method)

Shanghai Five Color Stone Medical Research Co.

National Instrumentation Note Approval 20153402293

11

Three-dimensional cardiac electrophysiology labeling system

Shanghai Wicresoft Electrophysiology Medical Technology Co.

National Instruments License 20163770387

12

Nucleic Acid Test Kit for Respiratory Pathogenic Bacteria (Constant Temperature Amplification Microarray Method)

Boao Bio Group Co.

National Instrumentation Note 20163400327

13

Decellularized corneal implant

Guangzhou Yudeqing Biotechnology Co.

National Instrument Registration 20163460573

14

Implantable vagus nerve stimulation pulse generator kit

Beijing Pinch Medical Equipment Co.

National Instrumentation Certificate 20163210989

15 Implantable Vagus Nerve Stimulation Electrode Lead Kit

Implantable Vagus Nerve Stimulation Electrode Lead Kit

Beijing Pinch Medical Equipment Co.

China National Instrumentation Certificate 20163210990

16

Drug-eluting peripheral balloon dilatation catheter

Beijing Xianreda Medical Technology Co.

China National Instrument license 20163771020

17

Cold saline infusion radiofrequency ablation catheter

Shanghai Wicresoft Electrophysiology Medical Technology Co.

China National Instrument Injection Quarantine 20163771040

18

Sternum plate

Changzhou Huasen Medical Equipment Co.

National Instrumentation Note 20163461582

19 Positron emission and X-ray computed tomography device

Positron emission and X-ray computed tomography device

Mingfeng Medical Systems Co.

National Instrumentation Note 20163332156

20

Artificial lens

Able Nord (Beijing) Medical Technology Co.

China National Instrument License 20163221747

21

Orthopedic surgery navigation and positioning system

Beijing Tianzhihang Medical Technology Co.

National Instrument Note Approval 20163542280

22

Cryoablation Surgical System

Haijia (Beijing) Medical Equipment Co.

National Instruments

20173583088

23

Disposable sterile cryoablation needle

Haijia (Beijing) Medical Devices Co.

National Instrument Note Approval 20173583089

24

Variable angle dual probe single photon emission computed tomography equipment

Beijing Yongxin Medical Equipment Co.

National Instruments Note 20173330681

25

Fully degradable sinus drug stent system

Puyi (Shanghai) Biotechnology Co.

China National Instrument License 201773460679

26

Percutaneous Intervention Prosthetic Heart Valve System

Hangzhou Qiming Medical Equipment Co.

China National Instrument License 20173460680

27

Interventional Prosthetic Heart Valve

Suzhou Jiecheng Medical Technology Co.

China National Instrument License 20173460698

28

Disposable absorbable nail intradermal anastomosis

Beijing Yihe Hengrui Medical Technology Co.

China National Instrument License 20173650874

29

Left ear occluder system

First Health Technology (Shenzhen) Co.

China National Instrument License 20173770881

30

Branched aortic coated stent and delivery system

Shanghai Wicresoft Medical Devices (Group) Co.

China National Instrument License 20173463241

31 Branched Aortic Overlay Stent and Delivery System

Folding artificial vitreous balloon

Guangzhou Weishi Bo Biotechnology Co.

China National Instruments License 20173223296

32

Abdominal Aortic Coated Stent System

Beijing Huazhantaike Medical Equipment Co.

China National Instrument Registration Certificate 20173461434

33 Implantable Cardiac Pacemaker

Implantable cardiac pacemaker

CCTC (Shenzhen) Co.

China National Instruments License 20173211570

34 Implantable Cardiac Pacemaker

Human EGFR gene mutation detection kit (multiplex fluorescence PCR method)

Xiamen Aide Bio-medical Technology Co.

National Instruments Note Approval 20183400014

35

Absorbable dural sealing medical adhesive  

Shandong Saikesys Pharmaceutical Technology Co.

National Instrument Note 20183650031

36

Vascular reconstruction device

Wicresoft Medical Technology (Shanghai) Co.

China National Instrument License 20183770102

37

miR-92a detection kit (fluorescent RT-PCR method)

Shenzhen Jinbaihui Biological Co.

National Instruments Note 20183400108

38

Hepatitis C Virus Nucleic Acid Assay Kit (PCR-Fluorescent Probe Method)

Beijing Najie Diagnostic Reagent Co.

National Instruments Note Quarantine 20183400157

39

Cerebral thrombus removal device

Jiangsu Nike Medical Equipment Co.

National Instruments Note 20183770186

40

Quantitative blood flow fraction measurement system

BMD Medical Imaging Technology (Shanghai) Co.

National Instruments Note 20183210282

41

Human EGFR/ALK/BRAF/KRAS Gene Mutation Combined Detection Kit (Reversible End Termination Sequencing Method)

Guangzhou Burnstone Medical Laboratory Co.

National Instruments Note Approval 20183400286

42

Automatic chemiluminescence immunoassay analyzer

Beijing Lianzhongtaike Technology Co.

National Instruments

20183220293

43

Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 gene mutation detection kit (semiconductor sequencing method)

Tianjin Novozymes Bioinformatics Co.

National Instrument Note Approval

20183400294

44

Composite hernia repair patch

Shanghai Songli Biotechnology Co.

National Instrument Note Approval 20183130292

45

Positron emission tomography and magnetic resonance imaging system

Shanghai Lianyin Medical Technology Co.

National Instruments

20183060337

46

EGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection Kit (Reversible End Termination Sequencing)

Nanjing Shihe Medical Equipment Co.

National Instruments Note Approval 20183400408

47

Implantable sacral nerve stimulation electrode lead kit

Beijing Pinch Medical Equipment Co.

China National Instrument License 20183120409

48 Implantable Sacral Nerve Stimulator

Implantable sacral nerve stimulator kit

Beijing Pinch Medical Equipment Co.

National Instruments Note 20183120410

49

Human SDC2 gene methylation detection kit (fluorescence PCR method)

Guangzhou Kang Liming Biotechnology Co.

National Instruments Note 20183400506

50

Human 10 gene mutation joint detection kit (reversible end termination sequencing method)

Xiamen Aide Bio-medical Technology Co.

National Instrument License 20183400507

51

Medical electronic linear gas pedal

Guangdong Zhongneng Accelerator Technology Co.

National Instrument Note 20183050520

52

Valvuloplasty ring

Jinshi Biotechnology (Changshu) Co.

National Instruments Note 20183130534

53

Neurosurgery navigation and positioning system

Huake Precision (Beijing) Medical Technology Co.

China National Instrument Registration 20183010598

54

Medical linear gas pedal system

Shanghai Lianyin Medical Technology Co.

National Instruments Note 20183050599

55

Porous tantalum bone filling material

Chongqing Runze Pharmaceutical Co.

National Instruments Note 20193130001

56 Bioabsorbable Coronary Rapamycin Eluting Stent System

Bioabsorbable Coronary Rapamycin Eluting Stent System

Lepu (Beijing) Medical Devices Co.

China National Instruments Registration Certificate 20193130093

57

Patient monitor

Shenzhen Myriad Bio-medical Electronics Co.

National Instruments Note Approval 20193070154

58

Abdominal aortic coated stent and delivery system

Wicresoft Medical Technology (Shanghai) Co.

China National Instruments Registration Certificate 20193130182

59

Left Auricle Closure System

Beijing MediTop Medical Technology Co.

China National Instrument License 20193130278

60

Left Ear Occluder System

Shanghai Pusi Medical Equipment Technology Co.

China National Instruments Note Approval 20193130279

61 Intensity-modulated radiation therapy planning system software

Intensity-modulated radiation therapy planning system software

Zhongke Super Precision (Anhui) Technology Co.

National Instrument Note 20193210281

62 Digital Mammography System

Digital mammography system

Shanghai Lianying Medical Technology Co.

National Instruments Note Approval 20193060280

63 Digital Mammography System

Positron emission and X-ray computed tomography scanning system

Hubei Ruishi Digital Medical Imaging Technology Co.

National Instruments

20193060364

64 Positron Emission and X-ray Computed Tomography Scanning System

Transcatheter implantable leadless pacing systemMicra Transcatheter Leadless Pacemaker system

Medtronic Inc.

Medtronic Inc.

National Instruments 20193120297

65

Transcatheter aortic valve system

Shanghai Wicresoft Medical Technology Co.

China National Instrument Injection 20193130494

66

Disposable intravascular imaging catheter

Nanjing Wolferman Medical Technology Co.

National Instrument Note Approval 20193060601

67

Non-invasive blood glucose meter

Bo Bang Fang Zhou Medical Technology (Beijing) Co.

China National Instruments License 20193070602

68 Implantable Left Ventricular Assist System

Implantable left ventricular assist system

Chongqing Yongrenxin Medical Equipment Co.

China National Instrument Registration Certificate 20193120603

69 Implantable Left Ventricular Assist System

Decellularized corneal implant

Qingdao Zhonghao Biological Engineering Co.

National Instruments Note 20193160679

70

Coronary angiography flow reserve fraction measurement system

Suzhou Runmed Medical Technology Co.

National Instrument Registration Approval 20193070969

71

Disposable invasive pressure transducer

Suzhou Runmed Medical Technology Co.

National Instrumentation Certificate 20193070970

72 Positron Emission and X-ray Computed Tomography Scanning System

Positron emission and X-ray computed tomography scanning system

Shanghai Lianying Medical Technology Co.

National Instrument License 20193060998

73 Nucleic Acid Amplification Analyzer

Nucleic Acid Amplification Analyzer

Hangzhou Yosida Biotechnology Co.

National Instrument Note Approval 20193061026

74

Puncture surgery navigation equipment

Meda Polaris Medical Technology (Suzhou) Co.

National Instrumentation Certificate 20203010034

75

Coronary flow reserve fraction calculation software

Beijing Kunlun Medical Cloud Technology Co.

National Instruments license 20203210035

76 Human EGFR/KRAS/BRAF/HER2

Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Mutation Detection Kit (Semiconductor Sequencing Method)

Xiamen Feishuo Biotechnology Co.

National Instrument License 20203400094

77

Pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing method)

Suzhou Bekang Medical Equipment Co.

National Instrument License 20203400181

78

Bioabsorbable coronary rapamycin eluting stent system

Shandong Hua'an Biotechnology Co.

National Instruments license 20203130197

79 Bioabsorbable Coronary Rapamycin Eluting Stent System

Drug balloon dilatation catheter

Shanghai Wicresoft Medical Technology Co.

National Instrument license 20203130445

80

Cardiovascular optical coherence tomography equipment and accessories