71 kinds Yixie 2016 or national Strict

For medical devices ring for 2015 is to monitor the bumper. In this year, large and small monitoring swept across Yixie circle. Large country, small cities and counties. But Yixie lawlessness still abound. Now 2016 is approaching, we are in the lap Yixie will face what?
Production, operation or part of the 2016 monitoring of key
Production processes is one of the most important medical devices ring part disposable infusion appliance, disposable catheters use of non-standard raw materials and did not seek sterilization, condoms without filing unauthorized commissioned production, hemodialysis concentrates not according to the standard factory inspection, etc., will be the focus of monitoring.

Another key monitoring is to be part of the business. Business links are the most difficult aspects of regulation is the most problematic part. Currently, the state’s emphasis on higher than expected Yixie ring 2016 the government will keep an eye on illegal operations and improper operation and so on.

Seven categories, 71 kinds Yixie or become a focus of the 2016 national surveillance
China Medical Devices that: in 2016 this country or for the following 71 categories Yixie be strictly control. The following is a specific list, the list is based on the problem more provinces according to the previous inspection, but each of the provinces and the national list of key regulatory focus on the list of regulatory overlap Yixie.

Variety category (class) directory
one

no

bacteria

class

1. one-time use of sterile syringes (including self-destructive, insulin injections, contrast with the high-pressure)

2. The one-time use of sterile needles (including dental injection pen)

3. disposable infusion (including precision, light, pressure infusion and other types)

4. time use of intravenous infusion needle

5. disposable intravenous catheter

6. A disposable vacuum blood collection

7. disposable blood transfusion

8. The single-use plastic bags

9. time use of narcotic puncture package

10. The disposable anesthesia needle

11. The one-time use of epidural anesthesia catheter

12. The medical suture needle (thread)

13. The disposable pressure transducer

14. The disposable insulin infusion pump device

15. The disposable pump dispenser

16. The disposable extension tube

17. The one-time use of intravenous nutrition infusion bag

18. Disposable dialysis type artificial kidney blood circuit

19. The one-time use of vacuum-assisted wound care material

two

plant

Enter

material

material

and

people

work

Device

official

class

1. Ordinary orthopedic implants (metal-containing, inorganic, polymeric materials such as plates, nails, pins, rods, wire, filling, repair materials, etc.)

2. Spine equipment

3. artificial joints

4. IOL

5. The stent (including intracranial arteriovenous and tubes and other central and peripheral stents)

6. heart defect repair / blocking device

7. Artificial heart valves

8. vascular anastomosis devices (including vascular stapler, aneurysm clips)

9. tissue filler material (including breast, plastic surgery and ophthalmology filling, etc.)

10. The medical absorbable suture

11. allogeneic Medical Devices

12. The animal source of medical equipment

13. A dental implant

14. The capsule endoscope system

15. The contact lens care solution

16. The contact lens rewetting drops

17. A surgical implant joint prostheses

three

body

outer

Consultation

Break

test

Preparation

class

1. people infected with highly pathogenic pathogenic microorganisms (third, four types of hazards) related to the detection reagent

2. associated with blood, tissue typing reagents

3. Other required cold chain storage and transportation of the third category in vitro diagnostic reagents

4. “National Key Regulated Medical Devices directory” other than the second, three in vitro diagnostic reagents medical devices

four

angle

membrane

Meet

touch

mirror

class

1. soft contact lens

2. plain color decorative contact lenses

3. orthokeratology

Fives

Assume

Equipment

instrument

Device

class

1. artificial heart device

2. The blood purification equipment

3. The infant care apparatus (including all types of incubator, rescue units)

4. Anesthesia Machine / Anesthesia Ventilator

5. life support ventilator

6. defibrillator

7. pacemaker

8. The disposable non-electrically driven infusion pump

9. The electrically driven infusion pump

10. The high potential therapeutic equipment

11. The high-frequency jet ventilator

12. Household in low frequency treatment device

13. A high potential therapeutic apparatus

14. The solid-state laser surgical equipment

15. The gas laser surgery equipment

16. A semiconductor laser treatment

17. .X-ray computed tomography apparatus

18. X-ray computed tomography apparatus

19. A magnetic resonance imaging system

20. Diagnostic Ultrasound System

21. X-ray diagnostic equipment

22. The digital medical X-ray imaging system

six

meter

Draw

Raw

Educate

class

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

2. IUD;

3. Infant Incubator

Seven

other

1. Surgical anti-adhesion of medical devices

2. Orthokeratology

3. Medical protective masks, medical protective clothing