The Regulations on the Supervision and Administration of Medical Devices ' e sa tsoa ntlafatsoa ( State Council Decree No.739, eo ka mor'a moo e bitsoang ' Regulations' e ncha ) e tla sebetsa ka June 1,2021.Tsamaiso ea Naha ea Lithethefatsi e hlophisa tokiso le ntlafatso ea melaoana e tšehetsang, litokomane tse tloaelehileng le tataiso ea setegeniki, tse tla phatlalatsoa ho latela mekhoa.Liphatlalatso mabapi le ho kengoa tšebetsong ha ' Melawana' e ncha ke tse latelang :
1. Ts'ebetsong e feletseng ea ngoliso ea lisebelisoa tsa bongaka, mokhoa oa ho kenya
Ho tloha ka la 1 Phuptjane 2021, likhoebo tsohle le litsi tsa nts'etsopele ea lisebelisoa tsa bongaka tse nang le litifikeiti tsa ngoliso ea lisebelisoa tsa bongaka kapa tse sebelitseng ho faela lisebelisoa tsa bongaka tsa Sehlopha sa I, ho latela lipehelo tsa Melaoana e mecha, li tla phethahatsa boitlamo ba bangolisi le lifaele tsa lisebelisoa tsa bongaka. ka ho latellana, ho matlafatsa tsamaiso ea boleng ba lisebelisoa tsa bongaka nakong eohle ea potoloho ea bophelo, le ho nka boikarabello bakeng sa polokeho le katleho ea lisebelisoa tsa bongaka ts'ebetsong eohle ea lipatlisiso, tlhahiso, ts'ebetso le ts'ebeliso ho latela molao.
2. Ho ngolisoa ha lisebelisoa tsa bongaka, tsamaiso ea ho kenya lifaele
Ho tloha ka la 1 Phuptjane 2021, pele ho phatlalatsoa le ho kengoa tšebetsong ha lipehelo tse amehang mabapi le ho ngolisoa le ho faela 'Melao' e ncha, bakopi ba ngoliso ea lisebelisoa tsa bongaka le lifaele ba tsoela pele ho etsa kopo ea ho ngolisoa le ho faela ho latela melaoana ea hajoale.Litlhoko tsa tlhahlobo ea bongaka ea lisebelisoa tsa bongaka li tla kenngoa ts'ebetsong ho latela Article 3 ea Phatlalatso ena.Lefapha la tlhokomelo le tsamaiso ea lithethefatsi le etsa mosebetsi o amanang le ngoliso le ho faela ho latela mekhoa ea hajoale le meeli ea nako.
3. Tsamaiso ea Tlhahlobo ea Clinical ea Lisebelisoa tsa Bongaka
Ho tloha ka la 1 Phuptjane 2021, bakopi ba ngoliso ea lisebelisoa tsa bongaka le lifaele ba tla etsa litlhahlobo ho latela 'Melao' e mecha.ba ikamahanyang le lipehelo tsa ' Melawana' e ncha ba ka 'na ba lokolloa tlhahlobong ea bongaka ;tlhahlobo ea bongaka e ka ipapisa le litšoaneleho tsa sehlahisoa, kotsi ea bongaka, lintlha tse teng tsa bongaka, joalo-joalo, ka liteko tsa bongaka, kapa ka mefuta e tšoanang ea lisebelisoa tsa bongaka lingoliloeng tsa bongaka, tlhahlobo ea lintlha tsa bongaka le tlhahlobo ho paka hore lisebelisoa tsa bongaka li bolokehile ebile lia sebetsa;lingoliloeng tsa kliniki tse teng, data ea kliniki ha ea lekana ho netefatsa polokeho ea sehlahisoa, lisebelisoa tse sebetsang tsa bongaka, li lokela ho etsa liteko tsa bongaka.Pele ho lokolloa le ho kengoa tšebetsong ha litokomane tse amehang tse lokolotsoeng tlhatlhobong ea bongaka, lenane la lisebelisoa tsa bongaka tse lokolotsoeng tlhahlobong ea bongaka le kengoa tšebetsong ho ipapisitsoe le lenane la hajoale la lisebelisoa tsa bongaka tse lokolotsoeng litekong tsa bongaka.
4.About lengolo la tlhahiso ea lisebelisoa tsa bongaka, tsamaiso ea ho kenya
Pele ho lokolloa le ho kengoa tšebetsong ha lipehelo tse amehang tsa 'Melao' e ncha e tšehetsang laesense ea tlhahiso le ho faela, bangoli ba lisebelisoa tsa bongaka le lifaele ba sebetsana le lilaesense tsa tlhahiso, ho kenya le ho fana ka tumello ea tlhahiso ho latela melaoana e teng le litokomane tse tloaelehileng.
5.On laesense ea khoebo ea sesebelisoa sa bongaka, taolo ea ho kenya
Sesebelisoa sa bongaka se ngolisitsoeng kapa se ngolisitsoeng ke sesebelisoa sa bongaka se ngolisitsoeng kapa motho ea ngolisitsoeng ea rekisang sesebelisoa sa bongaka se ngolisitsoeng kapa se ngolisitsoeng moo a lulang kapa aterese ea tlhahiso ha se hloke laesense ea khoebo ea sesebelisoa sa bongaka kapa ngoliso, empa se tla ipapisa le maemo a behiloeng a ts'ebetso;haeba mofuta oa bobeli le oa boraro oa lisebelisoa tsa bongaka li bolokoa le ho rekisoa libakeng tse ling, laesense ea khoebo ea sesebelisoa sa bongaka kapa rekoto e lokela ho sebetsoa ho latela lipehelo.
'Muso oa Tsamaiso ea Lithethefatsi o entse lethathamo la lihlahisoa tsa lisebelisoa tsa bongaka tsa sehlopha sa II tse lokolotsoeng ho ngolisoeng ha khoebo mme e batla likeletso ho sechaba.Ka mor'a hore lethathamo la lihlahisoa le lokolloe, latela lethathamo la libuka.
6. Patlisiso le kotlo ea boitšoaro bo seng molaong ba sesebelisoa sa bongaka
Haeba boitšoaro bo seng molaong ba lisebelisoa tsa bongaka bo etsahetse pele ho la 1 Phuptjane 2021, "Melao" pele ho ntlafatso e tla sebelisoa.Leha ho le joalo, haeba "Melao" e ncha e nka hore ha e molaong kapa kotlo e bobebe, "Melao" e ncha e tla sebelisoa.'Melao' e ncha e sebetsa moo tlolo ea molao e etsahetseng kamora la 1 Phuptjane 2021.
Ka hona e phatlalatsoa.
Tsamaiso ea Naha ea Lithethefatsi
La 31 Motšeanong 2021
Nako ea poso: Jun-01-2021