71 kinds of medical equipment 2016 or strictly controlled by the state


Release time:

2018-08-08

71 kinds of medical equipment 2016 or strictly controlled by the state

 
For the medical device circle, 2015 is the year of supervision. In this year, large and small monitoring swept the entire medical circle. Large to the whole country, small to the city and county. However, the phenomenon of illegal medical equipment is still endless. Now that 2016 is approaching, what will we face in the medical equipment circle?

 

 

 

Production and operationLinkor becomeMonitoring Highlights in 2016

 

The production link is one of the most important links in the medical device circle. Disposable infusion devices, disposable catheters use raw materials that do not meet the standards for production and are not sterilized as required. Condoms are commissioned for production without filing. Concentrates for hemodialysis are not inspected according to the standard factory, which will become the focus of monitoring.

 

Another key point to be monitored is the operation link. The business link is the most difficult to supervise the link is also the most prone to problems. At present, the state attaches more importance to the medical equipment circle than expected. In 2016, the government will focus on illegal operations and improper operations.

 

 

 

Seven categories and 71 kinds of medical equipment may become the focus of national monitoring in 2016.

 

China Medical Devices believes that in 2016, the state will strictly control the following 71 types of medical devices. The following is a specific list. The list is based on medical equipment that has many problems according to previous inspections in various provinces, and is the overlap between the provincial key supervision list and the national key supervision list.

 

Category

List of varieties (classes)

 

 

1

 

None

bacteria

Class

 

1.Sterile syringe for single use (including self-destruction type, insulin injection and high pressure imaging)

2.Sterile needle for single use (including dental and injection pen)

3.Disposable infusion set (including precision, dark, pressure infusion and other types)

4.Disposable intravenous infusion needle

5.Disposable intravenous indwelling needle

6.Single-use vacuum blood collector

7.Single use blood transfusion device

8.Disposable plastic blood bag

9.Disposable anesthesia puncture kit

10.single-use anesthesia needle

11.Single-use epidural anesthesia catheter

12.Medical suture needle (thread)

13.Single-use pressure sensor

14.Disposable insulin pump infusion set

15.Disposable use aspirator

16.One-time use extension tube

17.Disposable intravenous nutrition infusion bag

18.Blood circuit for disposable dialysis type artificial kidney

19.Disposable negative pressure drainage and wound protection materials

 

 

2

 

Plant

In

Material

Material

and

People

Work

device

Officer

Class

 

1.Ordinary orthopedic implants (plates, nails, needles, rods, wires, filling and repair materials containing metal, inorganic, polymer and other materials)

2.Spinal internal fixation equipment

3.artificial joint

4.artificial crystal

5.Vascular stent (including arteriovenous and intracranial central and peripheral vascular stent)

6.heart defect repair/Occlusion device

7.artificial heart valve

8.Vascular anastomosis devices (including vascular stapler, aneurysm clip)

9.Tissue filling materials (including breast, plastic and ophthalmic filling, etc.)

10.medical absorbable suture

11.allogeneic medical devices

12.Medical Devices of Animal Origin

13.Dental Implant

14.capsule endoscope system

15.Contact Lens Care Solution

16.Contact Lens Moisturizing Solution

17.Surgical implants Joint prostheses

 

 

3

 

body

Outside

Diagnosis

Broken

Try

Agent

Class

 

1.Reagents related to the detection of human infectious highly pathogenic microorganisms (Class III and IV hazards)

2.Reagents related to blood type and tissue matching

3.Other in vitro diagnostic reagents requiring cold chain storage and transportation

4.The second and third categories of in vitro diagnostic reagent medical device products other than the National Key Regulatory Medical Device Catalogue

 

 

Four

 

Angle

Membrane

connected

Touch

Mirror

Class

 

1.soft corneal contact lens

2.Decorative Colored Plain Contact Lenses

3.orthokeratology lens

 

 

5

 

Set

Preparation

Instrument

device

Class

 

1.artificial heart-lung equipment

2.Equipment for blood purification

3.Baby care equipment (including various incubators and rescue tables)

4.anesthesia machine/anesthesia ventilator

5.Ventilator for life support

6.Defibrillator

7.cardiac pacemaker

8.Disposable non-electrically driven infusion pump

9.electrically driven infusion pump

10.high potential therapy equipment

11.high frequency jet ventilator

12.Household medium and low frequency therapeutic apparatus

13.High potential therapeutic apparatus

14.Solid-state laser surgical equipment

15.Gas laser surgical equipment

16.Semiconductor laser therapeutic apparatus

17. .XX-ray computed tomography apparatus

18. XX-ray computed tomography equipment

19.magnetic resonance imaging system

20.ultrasonic diagnostic system

21. Xray diagnostic equipment

22.Digital MedicalXradiography system

 

 

Six

 

meter

Row

Born

Education

Class

 

1.Condoms (with natural latex rubber and synthetic materials)

2.IUD;

3.Infant incubator

Seven

 

Other

 

1. Surgical anti-adhesion medical devices

2. orthokeratology lens

3. Medical protective masks, medical protective clothing