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
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.
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
|
Related News