Priority approval for 3 types of medical devices

Posted on

Priority approval for 3 types of medical devices

According to the "Draft for Comment", CFDA intends to implement priority approval for the registration of three medical devices.

They are:

(1) Medical devices listed in the national science and technology major projects or national key research and development plans.

(2) Medical devices that meet one of the following conditions:

1. Diagnose or treat rare diseases with obvious clinical advantages;

2. Diagnosis or treatment of malignant tumors with obvious clinical advantages;

3. Diagnosis or treatment of endemic and multiple diseases in the elderly, and there is currently no effective diagnosis or treatment;

4. Diagnosis or treatment of children with unique and multiple diseases, and there is currently no effective diagnosis or treatment;

5. Medical devices that are urgently needed in clinical practice and are not approved for registration in China.

(3) Other medical devices that should be approved in priority.

Among them, the medical equipment listed in the national science and technology major special project or the national key research and development plan has priority in priority. The CFDA equipment evaluation center needs to review within 5 working days after receiving the application, and draw up whether to give priority approval. .

As for the (2) clinically needed medical devices and the (3) medical devices, the CFDA Device Evaluation Center will organize an expert demonstration review every month. If the experts agree, it will be drafted for priority approval.

As for innovative medical devices, because the CFDA has been in accordance with the special approval process, the "Draft for Comment" does not include it, and it is still implemented according to the original regulations.

Moreover, according to the "Draft for Comment", compared with the specially approved innovative medical devices, the three priority approved medical devices are expected to complete the entire product registration process in a shorter time.

3 priority approval medical devices VS innovative medical devices

First, the former application process is more simplified

If priority approval is required, the applicant may submit a priority approval application directly to CFDA;

For innovative medical devices, applicants should first submit a special approval application to the provincial food and drug administration. The provincial drug supervision bureau will submit the application to CFDA after completing the preliminary examination within 20 working days.

Second, the CFDA will review the application for the former for a shorter period of time.

If priority approval is required, if it is included in the national science and technology major project or the national key research and development plan, the CFDA review center shall conduct the audit within 5 working days after receiving the application; clinically necessary and other medical devices that should be approved in priority, CFDA per Monthly organization of expert demonstration review, that is, the audit time is within 30 days;

For innovative medical devices, the CFDA Innovative Medical Device Review Office organizes experts for review within a limited period of 40 working days.

Portable Ultrasound Series

SS-8 ARM Laptop Ultrasound B Scanner

Pretty and light

15 inch LCD screen

Full digital imaging technology crystal-clear Image

Broadband multi-frequency probes

2 probe connectors

Silica gel backlight gravure laser keyboard

SS-9 PC based Laptop Ultrasound B Scanner

15 inch LED screen

Pretty thin and light

2 probe connectors

Full digital imaging technology crystal-clear image

3D image function

PC based abundant function


SS-7 Singlechip Laptop Ultrasound Scanner

15 inch LCD screen

Full digital imaging technology crystal-clear Image

Pretty and light

8 segment TGC

Broadband multi-frequency probes

2 probe connectors

SS-6B Laptop All-Digital Ultrasound Diagnostic System

Product advantage >>>>>>
-High-definition, richly functional all-digital laptop ultrasound diagnostic system
-Mainly used in heart, abdomen, urology, obstetrics and gynecology, pediatrics etc
-Powerful image post-processing function. First-class digital imaging technology, clearer image.
Easy to operate, strong endurance
-Intelligent menu, easy and quick man-machine dialogue
Technical specifications>>>>>>
• Using ARM chip architecture, stable, concise and powerful.
• Uses 12 inch and 1024*768 resolution high-definition LED LCD screen.
• With an image post-processing function, and integrates a large amount of clinical experience with different preset adjustment conditions for the parts or organs examined in different departments and has a one-key optimization function.
• With different race formulas.
• Adopts hospital standard report form page settings, which can input hospital, patient, physician, diagnosis results and automatically inspect measurement data and select diagnosis pictures
• Multiple languages: Chinese, English, German, French, Spanish, Portuguese, Russian, Persian, Arabic etc.
• Built-in user manual.
2.3.1 Imaging modes: B, B+B, B+M, M, 4B
Probe array element: automatically identify and use a variety of array element probe(80 elements,96 elements,128 elements) Note: Only the probes produced by our company.
2.3.2 Cine playback:≥500 frame
2.3.3 Image storage: ≥360 images. External USB storage, single image storage time ≤9 seconds (storage speed is related to the USB device used)
2.3.4 Scanning angle adjustment: adjustable
2.3.5 Image magnification: separate swirl depth adjustment (25 levels adjustable);
2.3.6 Puncture: with puncture guide line, angle and position are adjustable
2.3.7 Focus: adjustable focus position, 5 levels of focus position adjustment
2.3.8 Image adjustment: up and down, left and right, brightness, focus position, dynamic range, scanning angle, frame correlation, M speed
2.3.9 Image processing: image smoothing/sharpening, tissue harmonics, gamma correction, false color
2.3.10 Notes and characters: date, clock, name, age, gender, doctor, hospital name, image annotation
2.3.11 Position mark: ≥97 types
2.3.12 Measurement
a) Routine: distance, perimeter, area, volume
b) Heart: 18 measurements including left atrium, right atrium, left ventricle, right ventricle, aorta, descending aorta, and aortic isthmus etc
c) Obstetric: 43 measurements including gestational sac, double parietal diameter, head circumference, abdominal circumference, femur length, fibula length, head buttock diameter, yolk sac, abdomen, large and small brain, last menstruation, amniotic fluid, gestational age, expected date of delivery, fetal weight etc
d) Gynecological: uterine body, cervix, endometrial thickness, ovary, follicle
e) Urology: kidney, adrenal gland, prostate, testicular mass, epididymis etc
f) Pediatric: common hepatic duct, common bile duct, pancreas, spleen, kidney, adrenal gland, etc
g) Small organ: thyroid, seminal vesicle, testis, scrotum, breast mass, skin mass, etc.
2.3.13 Report function: automatically generate reports on abdomen, urology, obstetrics, heart etc. SS-6 is equipped with an ultrasound workstation report page, which can extract and store 1-4 images. Use hospital standard report page settings, you can enter hospital, patient, physician, diagnosis result information etc. Automatically import inspection measurement data, and select diagnosis pictures
2.3.14 External interface: VGA interface, dual USB2.0 interface, RS232 interface
2.3.15 Power saving mode: The panel button light can be turned on and off by one key, and the instrument will automatically turn off the power if it is not used for 6 minutes. Press any key to resume operation


Portable Ultrasound Scanner,Portable Ultrasound Machine,Portable Ultrasound System,Portable Wireless Ultrasound

Guangzhou Sonostar Technologies Co., Limited , https://www.sonoeye.com