Nkhani

Kuyang'anira zida zamankhwala, 2020 wakhala chaka chodzaza ndi zovuta komanso chiyembekezo. M’chaka chathachi, mfundo zambiri zofunika zaperekedwa motsatizanatsatizana, zopambana zachitika povomereza zadzidzidzi, ndipo zatsopano zakhalapo…

01 Liwiro la kuwunika kwadzidzidzi ndi kuvomereza zida zachipatala kwafulumizitsa poyesetsa kupewa ndikuwongolera mliriwu.

Pambuyo pa kufalikira kwa Covid-19, Center for Medical Device Evaluation of National Medical Products Administration idakhazikitsa njira yowunikira mwadzidzidzi pa Januware 21. Owunikirawo adalowererapo pasadakhale ndikuyankha zadzidzidzi maola 24 patsiku kuti apereke chithandizo chapamwamba kwa olembetsa olembetsa pazogulitsa. chitukuko ndi kulembetsa. Pa Januware 26, zowunikira zina za coronavirus nucleic acid zidayamba kuvomerezedwa ku China; pa february 22, zida zozindikirira ma antibody za coronavirus zidayamba kuvomerezedwa, ndipo othandizirawa atha kukwaniritsa zomwe tikufuna kuyesetsa kuthana ndi mliriwu. Kuphatikiza apo, zida zina zamankhwala zomwe zimagwiritsidwa ntchito kuti zivomerezedwe mwadzidzidzi pofuna kupewa ndi kuwongolera miliri, monga ma gene sequencer, ma ventilator, komanso kusanthula kwa kutentha kosalekeza kwa nucleic acid, zavomerezedwanso.

02 Zida zingapo zachipatala zanzeru zopangira zidavomerezedwa kuti zizigulitsidwa.

Chaka chino, China yawona kupambana kwakukulu pakuvomerezedwa kwa zida zanzeru zopangapanga. Mu Januwale, Beijing Kunlun Medical Cloud Technology Co., Ltd. idalandira chiphaso choyamba cholembetsa chanzeru cha kalasi yachitatu yazachipatala chifukwa cha pulogalamu yake yowerengera; mu February, AI "ECG analysis software" ya Lepu Medical inalembedwa ndikuvomerezedwa; mu June, MR imaging-assisted diagnosis software for intracranial tumors inavomerezedwa ngati zipangizo zachipatala za Class III; Mu July, AI "ECG makina" a Lepu Medical adavomerezedwa; Mu August, mankhwala atsopano "Diabetic retinopathy fundus image-aid diagnosis software" yopangidwa ndi Shenzhen Siji Intelligent Technology Co., Ltd. ndi "Diabetic retinopathy analysis software" yopangidwa ndi Shanghai Yingtong Medical Technology Co., Ltd. Pofika pa Disembala 16, zida zonse zanzeru zopangira 10 zavomerezedwa kuti zilembedwe.

03 Zopereka Zokhudza Ulamuliro wa Mayesero Owonjezera a Zachipatala a Zida Zachipatala (zoyesa) Zatulutsidwa

Pa Marichi 20, National Medical Products Administration ndi National Health Commission molumikizana adapereka Zopereka pa Administration of Extended Clinical Trials of Medical Devices (kwa Mayesero), kulola zinthu zomwe zimapindulitsa pakuwunika koyambirira koma sizinavomerezedwe kuti zigulitsidwe. , kuti agwiritsidwe ntchito kwa odwala omwe ali ndi matenda aakulu omwe alibe chithandizo chothandizira, pokhapokha ngati chilolezo chodziwitsidwa chikupezeka ndikuwunikanso zoyenera. Kuphatikiza apo, zidziwitso zachitetezo zamayesero owonjezera azachipatala a zida zamankhwala zimaloledwa kugwiritsidwa ntchito polembetsa.

04 Chida chachipatala choyambirira cha ku China chogwiritsa ntchito zidziwitso zakunyumba zenizeni zovomerezeka kuti zitsatidwe

Pa Marichi 26, National Medical Products Administration idavomereza kulembetsa kwa “Glaucoma Drainage Tube” ya Allergan ya ku United States. Izi zimagwiritsa ntchito umboni weniweni wapadziko lonse womwe wasonkhanitsidwa ku Hainan Boao Lecheng Pioneer Area kuti awunikire kusiyana kwamitundu, kukhala chinthu choyamba chapakhomo chovomerezedwa kudzera munjira iyi.

05 2020 Hunting Convicts Online Initiative for Medical Devices Yaperekedwa ndi National Medical Products Administration

Pa Epulo 29, National Medical Products Administration idapereka 2020 "Hunting Convicts Online Initiative" for Medical Devices, yomwe imafuna kuti ntchitoyi ichitike "pa intaneti" komanso "paintaneti" ndipo chidziwitso ndi zinthu ziyenera kuphatikizidwa. Ntchitoyi idagogomezeranso kuti nsanja yachitatu yazida zachipatala pa intaneti iyenera kuyimbidwa mlandu pakuwongolera izi ndipo udindo waukulu uyenera kukhala wamakampani ogulitsa zida zamankhwala pa intaneti. Madipatimenti oyang'anira mankhwala osokoneza bongo adzakhala ndi udindo woyang'anira zida zogulitsidwa m'dera lawo, kuyang'anira zochitika zachipatala pa intaneti ziyenera kulimbikitsidwa, ndipo kuphwanya malamulo ndi malamulo kuyenera kufalitsidwa kwambiri.

06 Pilot Work Unique Device Identification (UDI) System Ikupita Patsogolo Mokhazikika

Pa Julayi 24, bungwe la National Medical Products Administration linachita msonkhano wolimbikitsa ntchito yoyeserera ya chipangizo chozindikiritsa chapadera (UDI), kufotokozera nthawi ndi nthawi mwachidule momwe ntchito yoyeserera ya UDI ikuyendera, ndikuthandizira kukulitsa mozama kwa woyendetsa. ntchito. Pa Seputembara 29, National Medical Products Administration, National Health Commission ndi National Healthcare Security Administration mogwirizana adapereka chikalata chowonjezera nthawi yoyeserera ya UDI ya zida zamankhwala mpaka pa Disembala 31, 2020. Kuwonjezedwa kwa gulu loyamba la magulu 9 ndi mitundu 69 ya zida zamankhwala za Gulu lachitatu zikhazikitsidwa pa Januware 1, 2021.

07 Kugwiritsa Ntchito Sitifiketi Yolembetsa Pamagetsi Pazida Zachipatala ndi National Medical Products Administration

Pa Okutobala 19, bungwe la National Medical Products Administration linapereka Chilengezo cha Pilot Application of Electronic Registration Certificate for Medical Devices, ndipo linaganiza zopereka ziphaso zolembetsera pakompyuta pazida zamankhwala moyeserera kuyambira pa Okutobala 19, 2020. Nthawi yoyeserera iyamba kuyambira pa Okutobala 19, 2020. October 19, 2020 mpaka pa Ogasiti 31, 2021. Zida zamankhwala zoyenerera kulandira ziphaso zotere zikuphatikiza zida zamankhwala zapakhomo za Gulu Lachitatu ndi zida zachipatala za Gulu II ndi III zomwe zidalembetsedwa koyamba. Zikalata zosintha ndi kukonzanso zolembetsa zidzaperekedwa pang'onopang'ono malinga ndi momwe zilili.

08 Sabata Yoyamba Yotsatsa Chitetezo Pazida Zamankhwala Zachipatala Idachitika

Kuyambira pa Okutobala 19 mpaka 25, National Medical Products Administration idachita Sabata Loyamba Lokwezera Chitetezo cha Zida Zamankhwala Padziko Lonse. Chokhazikika pa "kulimbikitsa mutu waukulu wa kukonzanso ndi kukonzanso ndi kukonza zoyendetsa zatsopano zachitukuko cha mafakitale", chochitikacho chinatsatira mfundo yokhudzana ndi zofuna komanso zovuta, ndikuchita zoyesayesa zake zolengeza m'njira zambiri. Pamwambowu, madipatimenti oyendetsa mankhwala m'magawo osiyanasiyana adagwira ntchito limodzi ndikudziwitsa anthu za zida zamankhwala pochita zinthu zosiyanasiyana.

09 Upangiri Waumisiri Wogwiritsa Ntchito Zenizeni Zapadziko Lonse Zowunikira Zachipatala Zazida Zachipatala (zoyesa) Zakhazikitsidwa

Pa November 26, National Medical Products Administration inapereka Upangiri Waumisiri Wogwiritsa Ntchito Real-World Data for the Clinical Evaluations of Medical Devices (for Trial) yomwe imatanthawuza mfundo zazikuluzikulu monga deta yeniyeni ya dziko, kufufuza kwenikweni, ndi umboni weniweni wa dziko. Chitsogozocho chinapereka zochitika zodziwika bwino za 11 zomwe umboni weniweni umagwiritsidwa ntchito poyesa zida zachipatala ndikulongosola njira yeniyeni yeniyeni yomwe imagwiritsidwa ntchito poyesa zipangizo zamankhwala, motero kukulitsa magwero a deta yachipatala.

10 Bungwe la National Food and Drug Administration Lakonzekera Kulimbitsa Kuyang'anira Kwabwino kwa Ma Coronary Stents Osankhidwa mu Centralized Procurement

Mu Novembala, boma lidakonza zogula zapakati pa coronary stents. Pa November 11, National Medical Products Administration inapereka chidziwitso cholimbikitsa kuyang'anira khalidwe la osankhidwa a coronary stents mu zogula zapakati pa dziko; Pa Novembara 25, National Medical Products Administration idakonza ndikuyitanitsa msonkhano wamakanema pazabwino ndi kuyang'anira chitetezo cha ma stents osankhidwa a coronary muzogula pakati pa dziko kuti apititse patsogolo kuyang'anira ndi kuyang'anira chitetezo cha zinthu zomwe zasankhidwa; Pa Disembala 10, Xu Jinghe, wachiwiri kwa director wa National Medical Products Administration, adatsogolera gulu loyang'anira ndi kufufuza kuti lifufuze kasamalidwe kabwino ka opanga awiri osankhidwa a coronary stent ku Beijing.

Source: China Association for Medical Devices industry