Mo le vaavaaiga o masini faafomai, 2020 o se tausaga e tumu i luitau ma faamoemoega.I le tausaga ua tuanaʻi, o le tele o faiga faʻavae taua na tuʻuina atu faʻasolosolo, o mea taua na faia i faʻamaoniga o faʻalavelave faʻafuaseʻi, ma faʻafouina suiga fou ua oʻo mai… Seʻi o tatou toe tepa faʻatasi i la tatou faigamalaga tulaga ese i le vaavaaiga o masini faafomaʻi i le 2020.
01 O le saoasaoa o iloiloga faʻafuaseʻi ma le faʻatagaina o masini faʻafomaʻi ua faʻavavevave i a matou taumafaiga e puipuia ma pulea le faʻamaʻi.
Ina ua maeʻa le faʻamaʻi o le Covid-19, na faʻalauiloa e le Center for Medical Device Evaluation of National Medical Products Administration se faʻataʻitaʻiga iloiloga faʻafuaseʻi ia Ianuari 21. Na faʻalavelave muamua le au suʻesuʻe ma tali atu i faʻalavelave faʻafuaseʻi 24 itula i le aso e tuʻuina atu auaunaga faʻapitoa mo le resitalaina o tagata talosaga mo oloa. atinae ma le resitalaina.I le aso 26 o Ianuari, na amata faʻamaonia ai nisi o vailaʻau faʻamaʻi coronavirus nucleic acid reagents i Saina;i le aso 22 o Fepuari, na amata faʻamaonia ai le coronavirus antibody detection reagents, ma e mafai e nei sooupu ona faʻafetaui manaʻoga o a tatou taumafaiga e faʻafefe ai le faʻamaʻi.E le gata i lea, o isi mea faʻafomaʻi faʻaaogaina mo faʻalavelave faʻafuaseʻi mo le faʻamoemoe o le puipuia ma le pulea o faʻamaʻi, e pei o gene sequencers, ventilators, ma faʻateleina le vevela o le nucleic acid analyzers, ua faʻamaonia foi.
02 Na fa'atagaina le tele o masini fa'afoma'i atamai mo le maketiina.
O lenei tausaga, ua vaʻaia e Saina ni faʻalavelave tetele i le faʻatagaina o masini faʻafomaʻi atamai.Ia Ianuari, na maua ai e Beijing Kunlun Medical Cloud Technology Co., Ltd. le tusi faamaonia muamua o le resitalaina o masini faʻafomaʻi faʻapitoa faʻapitoa vasega III mo lona faʻaagaga faʻaagaaga faʻaagaaga komepiuta komepiuta;ia Fepuari, le AI "ECG analysis software" a Lepu Medical na resitalaina ma faʻamaonia;ia Iuni, o le MR ata-fesoasoani suʻesuʻega polokalama mo intracranial tuma na faamaonia e Vasega III masini faafomai;Ia Iulai, na faʻamaonia ai le AI "ECG machine" a Lepu Medical;Ia Aokuso, o le oloa fou "Diabetic retinopathy fundus image-aided diagnostic software" na gaosia e Shenzhen Siji Intelligent Technology Co., Ltd. ma le "Diabetic retinopathy analysis software" na gaosia e Shanghai Yingtong Medical Technology Co., Ltd. na faamaonia mo le lisiina.E oʻo mai ia Tesema 16, e 10 le aofaʻi o oloa faʻapitoa faʻafomaʻi faʻapitoa ua faʻamaonia mo le lisiina.
03 Aiaiga i le Fa'afoega o Su'esu'ega Fa'a-Ma'i Fa'alautele o Mea Fa'afoma'i (mo Su'ega) Fa'asalalauina.
I le aso 20 o Mati, na tuʻufaʻatasia ai e le National Medical Products Administration ma le National Health Commission aiaiga i luga o le Pulega o Faʻataʻitaʻiga Faʻalautele Faʻataʻitaʻiga o Mea Faʻafomaʻi (mo Faʻataʻitaʻiga), faʻatagaina oloa e aoga i suʻesuʻega muamua ile falemaʻi ae e leʻi faʻatagaina mo le maketiina. , e fa'aaogaina mo gasegase tigaina e leai ni togafitiga lelei, pe a fai e maua le fa'atagaga fa'ailoa ma faia le iloiloga fa'atatau.E le gata i lea, o faʻamatalaga saogalemu o faʻataʻitaʻiga faʻalauteleina o falemaʻi o masini faʻafomaʻi e faʻatagaina e faʻaaogaina mo le resitalaina o talosaga.
04 Saina's First masini fa'afoma'i oloa fa'aoga fa'amaumauga fa'ale-lotoifale moni fa'amaonia mo le maketiina
I le aso 26 o Mati, na faʻamaonia ai e le National Medical Products Administration le resitalaina o le "Glaucoma Drainage Tube" o Allergan o le Iunaite Setete.O lenei oloa o lo'o fa'aogaina fa'amaoniga moni o le lalolagi na aoina i le Hainan Boao Lecheng Pioneer Area mo le iloiloga o eseesega fa'ale-tagata, ma avea ma oloa muamua fa'alotoifale fa'amaonia e ala i lenei auala.
05 2020 Tulaga Tausala Tausala i luga ole laiga Initia mo Mea Fa'afoma'i Fa'amatu'u mai e le National Medical Products Administration
I le aso 29 o Aperila, na tuʻuina atu ai e le National Medical Products Administration le 2020 "Hunting Convicts Online Initiative" mo Meafaigaluega Faʻafomaʻi, lea e manaʻomia ai e tatau ona faʻatautaia le fuafuaga "i luga ole laiga" ma le "offline" ma faʻamatalaga ma oloa e tatau ona tuʻufaʻatasia.Na faamamafaina foi e le fuafuaga e faapea o le vaega lona tolu mo auaunaga tau fefaʻatauaiga i luga o le initaneti e tatau ona tali atu mo le puleaina o ia fefaʻatauaiga ma o le matafaioi muamua e tatau ona taoto i pisinisi faʻatau i luga ole laiga mo masini faʻafomaʻi.E tatau ona nafa le matagaluega o tulafono faatonutonu mo le vaavaaiga o masini e faatauina atu i totonu o latou teritori, o le mataʻituina o masini faafomaʻi i luga o le initaneti e tatau ona faʻamalosia, ma soliga o tulafono ma tulafono faatonutonu e tatau ona matua faʻasalalau.
06 Galuega Fa'ata'ita'i Fa'ata'ita'iga Tulaga Tulaga Fa'asinomaga (UDI) Fa'agasolo Fa'agasolo
I le aso 24 o Iulai, na faia ai e le National Medical Products Administration se fonotaga e faʻalauiloa ai le galuega pailate o le faʻaogaina o masini tulaga ese (UDI), faʻapotopotoina i lea taimi ma lea taimi le alualu i luma ma le aoga o le galuega pailate mo le faiga o le UDI, ma faʻafaigofie le atinaʻeina loloto o le pailate. galuega.I le aso 29 o Setema, na tuʻuina atu ai e le National Medical Products Administration, le National Health Commission ma le National Healthcare Security Administration se pepa e faʻalautele ai le vaitaimi pailate o le UDI system mo masini faʻafomaʻi ia Tesema 31, 2020. O le faʻaopoopoga mo le vaega muamua o 9 vaega. ma 69 ituaiga o Vasega III masini faʻafomaʻi o le a faʻatinoina ia Ianuari 1, 2021.
07 Talosaga Fa'ata'ita'i ole Tusi Fa'ailoga Fa'aeletonika mo Meafaigaluega Fa'afoma'i e le Pulega o Mea Fa'afoma'i a le Atunu'u
I le aso 19 o Oketopa, na tuʻuina atu ai e le National Medical Products Administration le Faʻasalalauga i luga o le Pilot Application of Electronic Registration Certificate for Medical Devices, ma filifili ai e tuʻuina atu tusi resitala faʻaeletoroni mo masini faʻafomaʻi i luga o le pailate amata mai ia Oketopa 19, 2020. Oketopa 19, 2020 se'ia o'o ia Aukuso 31, 2021. O le lautele o masini fa'afoma'i e agava'a mo le mauaina o ia fa'ailoga e aofia ai le Vasega III masini fa'afoma'i i totonu o le atunu'u ma masini fa'afoma'i mai fafo Vasega II ma le III ua fa'amauina muamua.O tusi pasi mo suiga ma fa'afouga o le resitalaina o le a tu'uina fa'asolosolo e fa'atatau i le tulaga moni.
08 Ole Vaiaso ole Fa'alauiloaina ole Saogalemu Fa'afoma'i Muamua a le Atunu'u
Mai Oketopa 19 i le 25, National Medical Products Administration na faia le First National Medical Device Safety Promotion Week i luga o le atunuʻu lautele.Faʻatotonugalemu i le "faʻalauiloaina o le autu autu o le toe fuataʻiga ma le faʻafouina ma le faʻaleleia o avetaavale fou o le atinaʻeina o alamanuia", o le mea na tupu na faʻapipiʻi i se faʻatonuga ma faʻafitauli faʻafitauli, ma faʻatinoina ana taumafaiga faʻasalalau i le tele o itu.I le taimi o le mea na tupu, sa galulue faʻatasi matagaluega faʻatonutonu fualaau faʻasaina ma faʻalauteleina le faʻalauiloaina o tagata lautele e uiga i masini faʻafomaʻi e ala i le faia o le tele o gaioiga eseese.
09 Ta'iala Fa'atekinisi mo le Fa'aaogaina o Fa'amatalaga Moni a le Lalolagi mo Su'esu'ega Fa'afoma'i o Mea Fa'afoma'i (mo Su'ega) Fa'asalalauina.
I le aso 26 o Novema, na tuʻuina atu ai e le National Medical Products Administration le Technical Guidelines for Use Real-World Data for the Clinical Evaluations of Medical Devices (mo Trial) lea e faʻamatalaina ai manatu autu e pei o faʻamatalaga moni o le lalolagi, suʻesuʻega moni o le lalolagi, ma faʻamaoniga moni o le lalolagi.O le taʻiala na tuʻuina atu 11 tulaga masani e faʻaaogaina ai faʻamaoniga moni o le lalolagi i le suʻesuʻeina o falemaʻi o masini faʻafomaʻi ma faʻamalamalamaina le ala o faʻamatalaga moni o le lalolagi o loʻo faʻaaogaina i suʻesuʻega faʻapitoa o masini faʻafomaʻi, ma faʻalauteleina ai punaoa o faʻamatalaga falemaʻi.
10 Fa'atonu a le National Food and Drug Administration e fa'amalosia le lelei o le va'ava'aiga o le toto toto ua filifilia ile fa'atauga fa'atotonu.
Ia Novema, na faʻatulagaina ai e le setete le faʻatauga tuʻufaʻatasia o stent coronary.I le aso 11 o Novema, na tuʻuina atu ai e le National Medical Products Administration se faʻasilasilaga e faʻamalosia ai le vaʻavaʻa lelei o totoga faʻapitoa filifilia i le faʻatauga faʻapitoa a le atunuʻu;I le aso 25 o Novema, na faʻatulagaina ma taloina e le National Medical Products Administration se faʻasalalauga vitio i luga o le lelei ma le saogalemu o le vaavaaiga o stent coronary filifilia i totonu o le faʻatauga faʻapitoa a le atunuʻu e faʻaleleia le lelei ma le saogalemu o le vaavaaiga o oloa filifilia;I le aso 10 o Tesema, na taʻitaʻia ai e Xu Jinghe, sui faatonu o le National Medical Products Administration, se vaega e vaavaaia ma suʻesuʻe e suʻesuʻe le lelei o le gaosiga o le gaosiga o le gaosiga o le fatu fatu e lua i Beijing.
Punavai: Asosi a Saina mo pisinisi masini faafomai
Taimi meli: Me-24-2021