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?
\nProduction, operation or part of the 2016 monitoring of key
\nProduction 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.<\/p>\n
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.<\/p>\n
Seven categories, 71 kinds Yixie or become a focus of the 2016 national surveillance
\nChina 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.<\/p>\n
Variety category (class) directory
\none<\/p>\n
no<\/p>\n
bacteria<\/p>\n
class<\/p>\n
1. one-time use of sterile syringes (including self-destructive, insulin injections, contrast with the high-pressure)<\/p>\n
2. The one-time use of sterile needles (including dental injection pen)<\/p>\n
3. disposable infusion (including precision, light, pressure infusion and other types)<\/p>\n
4. time use of intravenous infusion needle<\/p>\n
5. disposable intravenous catheter<\/p>\n
6. A disposable vacuum blood collection<\/p>\n
7. disposable blood transfusion<\/p>\n
8. The single-use plastic bags<\/p>\n
9. time use of narcotic puncture package<\/p>\n
10. The disposable anesthesia needle<\/p>\n
11. The one-time use of epidural anesthesia catheter<\/p>\n
12. The medical suture needle (thread)<\/p>\n
13. The disposable pressure transducer<\/p>\n
14. The disposable insulin infusion pump device<\/p>\n
15. The disposable pump dispenser<\/p>\n
16. The disposable extension tube<\/p>\n
17. The one-time use of intravenous nutrition infusion bag<\/p>\n
18. Disposable dialysis type artificial kidney blood circuit<\/p>\n
19. The one-time use of vacuum-assisted wound care material<\/p>\n
two<\/p>\n
plant<\/p>\n
Enter<\/p>\n
material<\/p>\n
material<\/p>\n
and<\/p>\n
people<\/p>\n
work<\/p>\n
Device<\/p>\n
official<\/p>\n
class<\/p>\n
1. Ordinary orthopedic implants (metal-containing, inorganic, polymeric materials such as plates, nails, pins, rods, wire, filling, repair materials, etc.)<\/p>\n
2. Spine equipment<\/p>\n
3. artificial joints<\/p>\n
4. IOL<\/p>\n
5. The stent (including intracranial arteriovenous and tubes and other central and peripheral stents)<\/p>\n
6. heart defect repair \/ blocking device<\/p>\n
7. Artificial heart valves<\/p>\n
8. vascular anastomosis devices (including vascular stapler, aneurysm clips)<\/p>\n
9. tissue filler material (including breast, plastic surgery and ophthalmology filling, etc.)<\/p>\n
10. The medical absorbable suture<\/p>\n
11. allogeneic Medical Devices<\/p>\n
12. The animal source of medical equipment<\/p>\n
13. A dental implant<\/p>\n
14. The capsule endoscope system<\/p>\n
15. The contact lens care solution<\/p>\n
16. The contact lens rewetting drops<\/p>\n
17. A surgical implant joint prostheses<\/p>\n
three<\/p>\n
body<\/p>\n
outer<\/p>\n
Consultation<\/p>\n
Break<\/p>\n
test<\/p>\n
Preparation<\/p>\n
class<\/p>\n
1. people infected with highly pathogenic pathogenic microorganisms (third, four types of hazards) related to the detection reagent<\/p>\n
2. associated with blood, tissue typing reagents<\/p>\n
3. Other required cold chain storage and transportation of the third category in vitro diagnostic reagents<\/p>\n
4. “National Key Regulated Medical Devices directory” other than the second, three in vitro diagnostic reagents medical devices<\/p>\n
four<\/p>\n
angle<\/p>\n
membrane<\/p>\n
Meet<\/p>\n
touch<\/p>\n
mirror<\/p>\n
class<\/p>\n
1. soft contact lens<\/p>\n
2. plain color decorative contact lenses<\/p>\n
3. orthokeratology<\/p>\n
Fives<\/p>\n
Assume<\/p>\n
Equipment<\/p>\n
instrument<\/p>\n
Device<\/p>\n
class<\/p>\n
1. artificial heart device<\/p>\n
2. The blood purification equipment<\/p>\n
3. The infant care apparatus (including all types of incubator, rescue units)<\/p>\n
4. Anesthesia Machine \/ Anesthesia Ventilator<\/p>\n
5. life support ventilator<\/p>\n
6. defibrillator<\/p>\n
7. pacemaker<\/p>\n
8. The disposable non-electrically driven infusion pump<\/p>\n
9. The electrically driven infusion pump<\/p>\n
10. The high potential therapeutic equipment<\/p>\n
11. The high-frequency jet ventilator<\/p>\n
12. Household in low frequency treatment device<\/p>\n
13. A high potential therapeutic apparatus<\/p>\n
14. The solid-state laser surgical equipment<\/p>\n
15. The gas laser surgery equipment<\/p>\n
16. A semiconductor laser treatment<\/p>\n
17. .X-ray computed tomography apparatus<\/p>\n
18. X-ray computed tomography apparatus<\/p>\n
19. A magnetic resonance imaging system<\/p>\n
20. Diagnostic Ultrasound System<\/p>\n
21. X-ray diagnostic equipment<\/p>\n
22. The digital medical X-ray imaging system<\/p>\n
six<\/p>\n
meter<\/p>\n
Draw<\/p>\n
Raw<\/p>\n
Educate<\/p>\n
class<\/p>\n
1. Condoms (containing natural rubber latex and synthetic materials)<\/p>\n
2. IUD;<\/p>\n
3. Infant Incubator<\/p>\n
Seven<\/p>\n
other<\/p>\n
1. Surgical anti-adhesion of medical devices<\/p>\n
2. Orthokeratology<\/p>\n
3. Medical protective masks, medical protective clothing<\/p>\n","protected":false},"excerpt":{"rendered":"
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. […]<\/p>\n","protected":false},"author":1,"featured_media":60,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"_links":{"self":[{"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/posts\/58"}],"collection":[{"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=58"}],"version-history":[{"count":1,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/posts\/58\/revisions"}],"predecessor-version":[{"id":61,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/posts\/58\/revisions\/61"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=\/wp\/v2\/media\/60"}],"wp:attachment":[{"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=58"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=58"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.t-med.cn\/en\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=58"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}