Iyo ichangobva kudzokororwa ' Regulations on the Supervision and Administration of Medical Devices ' ( State Council Decree No.739, inozonzi ' Mitemo ' mitsva) ichaita muna June 1,2021.National Drug Administration iri kuronga kugadzirira uye kudzokorora mitemo inotsigira, magwaro enormative uye tekinoroji nhungamiro, izvo zvichaburitswa zvinoenderana nematanho.Zviziviso pamusoro pekushandiswa kweiyo ' Regulations ' mitsva ndeiyi inotevera:
1. Pakuitwa kwakazara kwekunyoreswa kwemidziyo yekurapa, hurongwa hwemafaira
Kutanga kubva muna Chikumi 1, 2021, mabhizinesi ese nemasangano ekuvandudza michina yekurapa ane zvitupa zvekunyoresa mudziyo wekurapa kana akabata faira reChikamu I michina yekurapa achaita, maererano nezviri muMitemo mitsva, kuzadzisa zvisungo zvevanonyoresa midziyo yekurapa nemafaira. zvichiteerana, simbisa hutongi hwemhando yezvishandiso zvekurapa mukati mehupenyu hwese, uye kutora mutoro wekuchengetedza uye kushanda kwemidziyo yekurapa mukuita kwese kwekutsvaga, kugadzira, kushanda uye kushandiswa zvinoenderana nemutemo.
2. Pakunyoreswa kwemidziyo yekurapa, kutungamira kwemafaira
Kubva musi waChikumi 1, 2021, kusati kwaburitswa uye kuita zviga zvakafanira pakunyoresa uye kufambisa kweiyo 'Mitemo' mitsva, vanonyorera kunyoreswa kwemidziyo yekurapa nemafaira vanoenderera mberi nekunyorera kunyoreswa uye kufambisa zvinoenderana nemirairo iripo.Zvinodiwa zvekuongororwa kwekiriniki zvemidziyo yekurapa zvichaitwa zvinoenderana neChikamu 3 cheChiziviso ichi.Dhipatimendi rekuona nezvezvinodhaka uye manejimendi rinoita basa rekunyoresa uye rekuisa mafaera zvinoenderana nemaitiro aripo uye nguva yakatarwa.
3. Kutungamirirwa kweClinical Evaluation yeMishonga Yezvokurapa
Kubva munaChikumi 1, 2021, vanyoreri vezvishandiso zvekurapa vanonyorera uye vanofaya vachaita ongororo yekiriniki zvinoenderana neiyo 'Mitemo' mitsva.avo vanotevedzera zvakatemwa zve' Mitemo ' mitsva vanogona kuregererwa kubva pakuongororwa kwekliniki;kuongororwa kwekiriniki kunogona kuenderana nemaitiro echigadzirwa, njodzi yekiriniki, iripo data yekiriniki, nezvimwewo, kuburikidza nemiedzo yekiriniki, kana kuburikidza nemhando dzakasiyana dzemidziyo yekurapa mabhuku ekiriniki, kuongororwa kwedhata rekiriniki uye kuongororwa kuratidza kuti michina yekurapa yakachengeteka uye inoshanda;aripo mabhuku ekiriniki, data yekiriniki haina kukwana kusimbisa kuchengetedzwa kwechigadzirwa, zvishandiso zvekurapa zvinoshanda, zvinofanirwa kuita miedzo yekiriniki.Kusati kwasunungurwa uye kushandiswa kwemagwaro akakodzera akasunungurwa kubva pakuongororwa kwekliniki, rondedzero yezvigadzirwa zvezvokurapa zvakasunungurwa kubva pakuongororwa kwekliniki inoshandiswa maererano nerondedzero yemazuva ano yezvigadzirwa zvemishonga zvisingabhadharwi kubva mukuedzwa kwekliniki.
4.About rezinesi rekugadzira mudziyo wekurapa, manejimendi ekufambisa
Kusati kwaburitswa uye kuitiswa kwezvinodiwa zveiyo 'Mitemo' mitsva inotsigira marezinesi ekugadzira uye faira, vanyoreri vemidziyo yekurapa uye mafaira vanobata marezinesi ekugadzira, kufaira uye kupihwa basa rekugadzira zvinoenderana nemirau iripo uye zvinyorwa zvinozivikanwa.
5.On medical device bhizinesi rezinesi, faira maneja
Chishandiso chekurapa chakanyoreswa kana kunyoreswa nechishandiso chekurapa chakanyoreswa kana munhu akanyoreswa anotengesa mudziyo wekurapa wakanyoreswa kana kunyoreswa kwaanogara kana kero yekugadzira haudi rezinesi rebhizinesi remudziyo wekurapa kana kunyoreswa, asi unoenderana nemamiriro ekushanda akatarwa;kana mhando yechipiri neyechitatu yezvishandiso zvekurapa zvakachengetwa uye zvichitengeswa kune dzimwe nzvimbo, rezinesi rebhizinesi remuchina wekurapa kana rekodhi rinofanirwa kugadziriswa zvinoenderana nezvinodiwa.
State Drug Administration yakanyora kabhuku kechikamu II zvigadzirwa zvemidziyo yekurapa zvisingabhadharwe kunyoreswa kwebhizinesi uye iri kutsvaga zano kuruzhinji.Mushure mekunge chigadzirwa katarosi yaburitswa, tevera iyo catalog.
6.Kuongorora uye kurangwa kwemaitiro asiri pamutemo emudziyo wekurapa
Kana maitiro asiri pamutemo emidziyo yekurapa akaitika June 1, 2021 asati asvika, "Mitemo" isati yadzokororwa ichashandiswa.Zvisinei, kana "Mitemo" itsva ichiona kuti haisi pamutemo kana kuti kurangwa kwakareruka, "Mitemo" itsva ichashandiswa.Iwo matsva 'Regulations' anoshanda uko mhosva yakaitika mushure me1 Chikumi 2021.
Zvinoziviswa.
National Drug Administration
Chivabvu 31, 2021
Nguva yekutumira: Jun-01-2021