Six kinds of medical or state key supervision

The source of | medical | small member of the author China

Since 2015, the state and the degree of attention to the medical device industry more. Fly check, inspection, rectification has become synonymous with medical circle.

In addition, the food and Drug Administration promulgated the "quality supervision and management measures of the use of medical devices". Established

Medical devices "full control" mode, the whole process of supervision of medical devices manufacture, inspection, classification, clinical evaluation, registration, production, management, use, adverse event monitoring and re evaluation, recall and other links.

Nevertheless, the problems also emerge in an endless stream medical circle. Since then, ring up three medical typhoon named supervision, inspection, rectification of the fly. Involving 6 provinces Shaanxi, Shandong, Hubei, Liaoning, Anhui, Guangzhou etc..

From the results, the most serious problem is the following six categories of medical, future or by the state as a key inspection object.

category

Varieties (class) directory

nothing

bacterium

class

1 disposable sterile syringes (including self destruct, injection of insulin, with high contrast)

2 disposable sterile needles (including dental, injection pen)

3 disposable infusion (including precision, light, pressure infusion of each type)

4 disposable intravenous infusion needle

5 disposable intravenous indwelling needle

6 disposable vacuum blood collection device

7 disposable blood transfusion device

8 disposable plastic blood bag

9 disposable anesthesia puncture bag

10 artificial heart lung auxiliary device (contact line, filter the blood etc.)

Apparatus for 11 blood purification (contact line, filter / blood dialysis / adsorption equipment)

12 oxygenator

13 intravascular catheter

14 balloon catheter

15 central venous catheter

16 peripheral vascular cannula

17 arteriovenous guidewire, sheath

18 endovascular devices (including closure of occluder, thromboembolism, microspheres)

19 medical protective mask, medical protective clothing

plant

income

material

material

and

people

work

organ

organ

class

1 ordinary Department of orthopedics implants (including metal, polymer, inorganic materials such as plate, screw, needle, rod, wire, filling, repair materials etc.)

2 spinal fixation device

3 artificial joint

4 intraocular lens

5 stents (including dynamic support for intracranial veins and other central and peripheral vessels)

6 heart defect repair / plugging device

7 artificial heart valve

8 vascular anastomosis device

9 tissue filling material

10 absorbable suture

11 allograft medical devices

12 animal medical devices

body

other

examine

break

test

agent

class

1 people infected with highly pathogenic microbes (third, four kinds of reagent related hazards)

2 associated with blood, tissue typing reagent

3 other cold chain storage and transportation of third kinds of in vitro diagnostic reagents

angle

film

connect

contact

mirror

class

soft corneal contact lens

set up

equipment

instrument

organ

class

1 artificial heart lung apparatus

With 2 blood purification equipment

3 baby nursery equipment

4 anesthesia machines / anesthesia ventilator

5 life support with a ventilator

6 defibrillator

7 cardiac pacemaker

8 non electric drive type disposable infusion pump

9 electric drive type infusion pump

10 high potential therapeutic equipment

living

educate

class

Condom