Iyo China Chikafu neDrug Administration yakaburitsa vhezheni nyowani ye "Medical Device Classification Catalogue" inoshanda kubva Nyamavhuvhu 1, 2018.

Musi waGunyana 4, 2017, State Food and Drug Administration (inozonzi "General Administration") yakaita musangano nevatori venhau kuti iburitse zviri pamutemo "Classification Catalog for Medical Devices" (inozozivikanwa seNew "Classification Catalog". ”).Kushanda kubva Nyamavhuvhu 1, 2018.

Medical device classification management ndiyo inogamuchirwa pasi rose modhi yekutonga, uye sainzi uye zvine musoro kupatsanura mudziyo wezvokurapa ndiyo hwaro hwakakosha hwekutariswa kwese kunyoreswa kwemidziyo yekurapa, kugadzira, kushanda uye kushandiswa.

Parizvino, kune zviuru makumi manomwe nenomwe zvitupa zvekunyoreswa kwemidziyo yekurapa uye anopfuura zviuru makumi matatu nenomwe zvitupa zvekunyoreswa kwemidziyo yekurapa muChina.Nekukurumidza kusimudzira kweindasitiri yemidziyo yekurapa uye nekuenderera mberi kwekubuda kwetekinoroji nyowani uye zvigadzirwa zvitsva, chirongwa chekurapa chigadziriso chakatadza kuzadzisa zvinodiwa zvekusimudzira maindasitiri nebasa rekutonga.Iyo 2002 vhezheni ye "Medical Device Classification Catalog" (inozozivikanwa seyekutanga "Classification Catalog") Kukanganisa kweindastiri kwave kwakanyanya uye kwakanyanya kuoneka: Kutanga, yekutanga "Classification Catalog" haina kutsanangurwa zvakakwana, uye iyo hurongwa hwese uye nhanho yekumisikidza haigone kusangana nemamiriro azvino eindastiri uye zvinodiwa zvekutonga.Chechipiri, iyo yekutanga "Catalogue" yakashaya ruzivo rwakakosha senge tsananguro yechigadzirwa uye chinangwa chekushandiswa, izvo zvakakanganisa kufanana uye kumira kwemvumo yekunyoresa.Chechitatu, iyo yekutanga "Category Catalog" yaive yakaoma kuvhara zvigadzirwa zvitsva uye zvikamu zvitsva.Nekuda kwekushaikwa kwesimba rekugadzirisa masisitimu, zvirimo mukatalogu hazvigone kuvandudzwa nenguva, uye chikamu chechikamu chechikamu chaive chisina musoro.

Kuti tiite "Mitemo pamusoro peKutarisira uye Kutungamirirwa kweMishonga Yezvokurapa" yakadzokororwa uye yakashambadzirwa neHurumende Council uye "Maonero eDare reHurumende pamusoro peKugadzirisa Ongororo uye Kubvumira Sistimu Yezvinodhaka neMishonga Yezvokurapa", iyo State Chikafu neMishonga. Utungamiri hwakapfupisa nekuongorora zvizere michina yekurapa yakapihwa makore apfuura zvichienderana nekutumirwa kwemagadzirirwo ekugadzirisa zvigadziriso zvemidziyo yekurapa.Kurongwa kwemudziyo uye mafaera etsanangudzo, kuronga ruzivo rwezvishandiso zvekunyoreswa kwemidziyo yekurapa, uye kuongorora manejimendi emidziyo yekurapa yakafanana.Basa rekudzokorora rakatangwa muna Chikunguru 2015, uye iyo yakazara optimization uye kugadziriswa kweiyo hurongwa, chimiro uye zvirimo zve "Classification Catalog" yakaitwa.Gadzirisa Medical Device Classification Technical Committee neboka rayo rehunyanzvi, yakaratidza zvine hungwaru hunyanzvi hwesainzi uye kurongeka kwezviri mukati me "Classification Catalog", uye yakagadziridza iyo itsva "Classification Catalog".

Iyo nyowani "Category Catalog" yakakamurwa kuita 22 sub-zvikamu zvinoenderana nehunhu hwekurapa mudziyo tekinoroji uye kushandiswa kwekiriniki.Iwo madiki-zvikamu anoumbwa ekutanga-chikamu chechigadzirwa, chechipiri-chikamu chechigadzirwa, tsananguro yechigadzirwa, chinangwa chekushandiswa, mienzaniso yemazita echigadzirwa, uye manejimendi mapoka.Kana uchitarisa chikamu chechigadzirwa, kutsunga kwakadzama kunofanirwa kuitwa zvichienderana nemamiriro chaiwo echigadzirwa, akasanganiswa nerondedzero yechigadzirwa, chinangwa chekushandiswa uye mienzaniso yemazita echigadzirwa mune itsva "Classification Catalog".Zvinhu zvikuru zve "Classification Catalog" itsva ndezvizvi: Kutanga, chimiro chakanyanya chesayenzi uye chinoenderana nekliniki yekudzidzira.Kudhirowa zvidzidzo kubva kukiriniki yekushandisa-yakatarisana classification system muUnited States, zvichireva chimiro che "Framework Catalog for Notified Bodies yeEuropean Union", iyo 43 sub-categories yeikozvino "Classification Catalog" yakasanganiswa kuita makumi maviri nemaviri. sub-categories, uye mazana maviri nemakumi matanhatu emhando yezvigadzirwa akakwenenzverwa uye akagadziridzwa kusvika 206 ekutanga-chikamu chechigadzirwa zvikamu uye 1157 yechipiri-chikamu chechipiri-chigadzirwa zvikamu zvinoumba matatu-nhanho catalogue hierarchy.Chechipiri, kufukidzwa kwakafara, kunodzidzisa uye kushanda.Zvinopfuura 2,000 zvigadzirwa zvitsva zvakawedzerwa kune zvinotarisirwa kushandiswa uye kutsanangurwa kwechigadzirwa, uye ikozvino "Classification Catalog" yakawedzerwa kune 6,609 mienzaniso ye1008 mazita echigadzirwa.Yechitatu ndeyekugadzirisa zvine hungwaru manejimendi ezvigadzirwa zvemhando, kuvandudza kuchinjika kweiyo indasitiri mamiriro uye tarisiro chaiyo, uye nekupa hwaro hwekugonesa kugoverwa kwezviwanikwa zvekutarisa.Zvinoenderana nechiyero chenjodzi yechigadzirwa uye nekutarisisa chaiko, chikamu chekutungamira chemakumi mana ezvigadzirwa zvemishonga zvekurapa zvine nguva refu yekutengesa, kukura kwechigadzirwa kwakanyanya uye njodzi dzinodzoreka dzakaderedzwa.

Iyo dhizaini uye zvirimo zve "Classification Catalog" nyowani zvakagadziridzwa zvakanyanya, izvo zvichave nemhedzisiro pane zvese zvekurapa mudziyo kunyoresa, kugadzira, kushanda, uye kushandiswa.Kuti ive nechokwadi chekunzwisisa kwakabatana kwemapato ese, shanduko yakatsetseka, uye kuita zvakarongeka, State Food and Drug Administration panguva imwe chete yakapa uye yakaisa "Chiziviso pamusoro peKuitwa kweiyo Ichangobva Kudzokororwa.”, ichipa rinenge gore rekuita shanduko yenguva.Kutungamira zviremera zvinotungamira uye mabhizinesi ane hukama kuti aite.Nezve manejimendi ekunyoresa, tichinyatsofunga nezve mamiriro eiyo indasitiri yemidziyo yekurapa, kutora nzira yekuchinja yakasikwa kuti iite iyo itsva "Classification Catalog";yekutariswa kwemashure ekushambadzira, kugadzirwa uye kutariswa kwekushanda kunogona kutora matsva uye ekare emhando yekukodha masisitimu akafanana.Iyo State Chikafu neDrug Administration icharonga ese-kutenderera sisitimu yekudzidziswa pane nyowani "Classification Catalog" uye kutungamira zviremera zvemuno nemakambani ekugadzira kuita iyo itsva "Classification Catalog."

2018 itsva yezvokurapa Classification katalogi Content source: China Food and Drug Administration, http://www.sda.gov.cn/WS01/CL0051/177088.html


Nguva yekutumira: Mar-02-2021