Maka nlekọta ngwaọrụ ahụike, 2020 abụrụla afọ juputara na ihe ịma aka na olile anya.N'ime afọ gara aga, ewepụtala ọtụtụ atumatu dị mkpa n'ụzọ gara nke ọma, emebela nnukwu ọganiihu na nkwado mberede, yana ihe ọhụrụ dị iche iche abanyela… Ka anyị leghachi anya azụ na njem anyị pụrụ iche na nlekọta ngwaọrụ ahụike na 2020.
01 Usoro nyocha ihe mberede na nkwenye nke ngwaọrụ ahụike agbagoro ngwa ngwa na mbọ anyị iji gbochie na ịchịkwa ọrịa a.
Mgbe ntiwapụ nke Covid-19 gasịrị, Center for Medical Device Evaluation of National Medical Products Administration malitere usoro nyocha ihe mberede na Jenụwarị 21. Ndị nyocha ahụ tinyere aka n'ihu ma zaghachi ihe mberede 24 awa kwa ụbọchị iji nye ọrụ dị elu maka ndị na-edebanye aha maka ngwaahịa. mmepe na ndebanye aha.Na Jenụwarị 26, a malitere ịkwado ụfọdụ reagents nchọpụta nucleic acid na China;na February 22, anabatara ndị na-ahụ maka ihe mgbochi coronavirus, ndị ọrụ a nwere ike gboo mkpa nke mbọ anyị iji luso ọrịa a ọgụ.Na mgbakwunye, akụrụngwa ọgwụ ndị ọzọ ejiri maka nnabata ihe mberede maka ebumnuche mgbochi na njikwa ọrịa ọrịa, dị ka usoro mkpụrụ ndụ ihe nketa, ikuku ventilashị, na ndị nyocha nucleic acid na-amụba ọnọdụ okpomọkụ mgbe niile, ka akwadokwara.
02 Ọtụtụ ngwaọrụ ahụike mmadụ ka akwadoro maka ịzụ ahịa.
N'afọ a, China ahụla nnukwu ọganihu na nkwado nke ngwaọrụ ahụike ọgụgụ isi.N'ọnwa Jenụwarị, Beijing Kunlun Medical Cloud Technology Co., Ltd nwetara akwụkwọ ndebanye aha ngwaọrụ ahụike nke mbụ artificial Intelligence Class III maka sọftụwia nchekwa nchekwa akụkụ nke akụkụ ya;na February, AI "ECG analysis software" nke Lepu Medical debara aha na kwadoro;na June, MR imaging-enyere aka nyocha ngwanrọ maka etuto intracranial ka akwadoro dị ka ngwaọrụ ahụike klas III;Na July, AI "igwe ECG" nke Lepu Medical kwadoro;N'August, ngwaahịa ọhụrụ "Diabetic retinopathy fundus image-enyere aka nyocha ngwanrọ" nke Shenzhen Siji Intelligent Technology Co., Ltd. mepụtara na "Software nyocha ọrịa shuga retinopathy" nke Shanghai Yingtong Medical Technology Co., Ltd. mepụtara ka akwadoro maka ịdepụta.Ruo Disemba 16, akwadoro ngwaahịa ngwaọrụ ahụike mmadụ iri maka ịdepụta.
03 Nkwanye na nchịkwa nke agbatịla nnwale ụlọ ọgwụ nke ngwaọrụ ahụike (maka nnwale) akpọsara
Na Machị 20, National Medical Products Administration na National Health Commission jikọrọ aka nyere iwu na nchịkwa nke Extended Clinical Trials of Medical Devices (maka nnwale), na-enye ohere ngwaahịa ndị bara uru na nyocha ụlọ ọgwụ izizi mana akwadobeghị maka ire ahịa. , iji mee ihe maka ndị ọrịa na-arịa ọrịa siri ike na-enweghị ọgwụgwọ dị irè, ma ọ bụrụhaala na enwetara nkwenye ọmụma ma na-eduzi nyocha nke ọma.Na mgbakwunye, a na-ahapụ data nchekwa nke nnwale ụlọ ọgwụ agbatịkwuru maka ngwa ndebanye aha.
04 Ngwaahịa ọgwụ izizi nke China na-eji data ezigbo ụwa akwadoro maka ire ahịa
Na Machị 26, Ụlọ Ọrụ Na-ahụ Maka Ngwaahịa Ahụike Mba kwadoro ndebanye aha nke "Glaucoma Drainage Tube" nke Allergan nke United States.Ngwaahịa a na-eji ihe akaebe na-ahụ maka ụlọ ọgwụ anakọtara na mpaghara Hainan Boao Lecheng Pioneer maka nleba anya nke ndịiche agbụrụ, na-aghọ ngwaahịa ụlọ mbụ kwadoro site na ọwa a.
05 2020 Ịchụ nta amamikpe ọnlaịnụ maka ngwa ahụike nke National Medical Product Administration nyere
Na Eprel 29, nchịkwa ngwaahịa ahụike mba nyere 2020 “ịchụ nta ndị ikpe n'ịntanetị Initiative” maka ngwaọrụ ahụike, nke chọrọ ka emee atụmatụ a ma “online” na “anọghị n'ịntanetị” yana ozi na ngwaahịa kwesịrị ijikọ.Ebumnuche a kwusiri ike na ikpo okwu nke atọ maka ọrụ ịzụ ahịa ngwaọrụ ọgwụ n'ịntanetị kwesịrị ịza ajụjụ maka ijikwa azụmahịa dị otú ahụ yana ọrụ bụ isi kwesịrị ịdị n'aka ụlọ ọrụ na-ere ahịa n'ịntanetị maka ngwaọrụ ahụike.Ngalaba na-ahụ maka ọgwụ ọjọọ ga-ahụ maka nlekọta nke ngwaọrụ ndị a na-ere n'ime ókèala ha, nleba anya nke azụmahịa ngwaọrụ ọgwụ n'ịntanetị kwesịrị ịdịwanyewanye njọ, na ekwesịrị ibipụta mmebi iwu na ụkpụrụ.
06 Ọrụ Pilot Nchọpụta Ngwaọrụ Pụrụ Iche (UDI) Sistemụ Na-aga n'ihu na-aga n'ihu
Na July 24, National Medical Products Administration nwere nzukọ iji kwalite ọrụ pilot nke usoro njirimara ngwaọrụ pụrụ iche (UDI), na-achikota ọganihu na ịdị irè nke ọrụ pilot maka usoro UDI, na ịkwado mmepe miri emi nke onye na-anya ụgbọelu. ọrụ.Na Septemba 29, National Medical Products Administration, National Health Commission na National Healthcare Security Administration jikọtara ọnụ nyere akwụkwọ iji gbatịa oge pilot nke sistemu UDI maka ngwaọrụ ahụike ruo Disemba 31, 2020. Mgbatị maka nkeji mbụ nke ụdị 9. na ụdị ngwaọrụ ahụike 69 klaasị III ka a ga-emejuputa na Jenụwarị 1, 2021.
07 Ngwa pilot nke akwụkwọ ndebanye aha eletrọnịkị maka ngwaọrụ ahụike site na nchịkwa ngwaahịa ahụike mba
N'October 19, National Medical Products Administration nyere ọkwa na Pilot Application of Electronic Registration Certificate for Medical Devices, ma kpebie ịnye akwụkwọ ndebanye aha eletrọnịkị maka ngwaọrụ ahụike na pilot malite na Ọktọba 19, 2020. Oge pilot ga-amalite site na Ọktoba 19, 2020 ruo Ọgọst 31, 2021. Oke ngwaọrụ ahụike tozuru oke ịnata asambodo ndị a gụnyere ngwaọrụ ahụike ụlọ klas III yana ngwaọrụ ahụike klaasị II na nke III ebubata nke edebara aha mbụ.A ga-enye nke nta nke nta akwụkwọ ikike maka mgbanwe na mmeghari ndebanye aha dabere na ọnọdụ ahụ n'ezie.
08 Izu nkwalite nchekwa ngwaọrụ ahụike mba izizi emere
Site na Ọktoba 19 ruo 25, nchịkwa ngwaahịa ahụike mba mere izu nkwalite nchekwa ngwaọrụ ahụike nke mbụ nke mba n'oke mba.Dabere na "ịkwalite isi isiokwu nke mgbanwe na ihe ọhụrụ na imeziwanye ndị ọkwọ ụgbọ ala ọhụrụ nke mmepe ụlọ ọrụ", ihe omume ahụ gbadoro ụkwụ n'ụkpụrụ chọrọ na nsogbu, ma mee mgbalị mgbasa ozi ya n'ọtụtụ akụkụ.N'oge mmemme ahụ, ngalaba na-ahụ maka ọgwụ na-arụ ọrụ dị iche iche na-arụkọ ọrụ ọnụ ma kwalite mmata nke ọha na eze gbasara ngwaọrụ ahụike site n'ịrụ ọrụ dị iche iche.
Ntuziaka Nka na ụzụ 09 maka iji data ụwa n'ezie maka nyocha ụlọ ọgwụ nke ngwaọrụ ahụike (maka nnwale) agbasa.
Na Nọvemba 26, Ụlọ Ọrụ Na-ahụ Maka Ọgwụ Na-ahụ Maka Ọgwụ nke Mba nyere ntụziaka teknụzụ maka iji data Real-World maka nyocha ahụike nke ngwaọrụ ahụike (maka nnwale) nke na-akọwapụta echiche ndị dị mkpa dị ka data ụwa n'ezie, nchọpụta ụwa n'ezie, na ihe akaebe ụwa.Ntuziaka ahụ tụpụtara ọnọdụ 11 na-ahụkarị nke a na-eji ihe akaebe nke ụwa eme ihe na nyocha ụlọ ọgwụ nke ngwaọrụ ahụike ma kọwaa ụzọ nke data n'ezie na-eji na nyocha ụlọ ọgwụ nke ngwaọrụ ahụike, si otú a gbasaa isi mmalite nke data ụlọ ọgwụ.
10 Ndị nlekọta nri na ọgwụ nke mba ahụ ahaziri iji mee ka nlekọta dị mma nke Coronary Sent ndị ahọpụtara na ịzụ ahịa etiti.
N'ọnwa Nọvemba, steeti haziri ịzụrụ stent nke akwara obi.Na Nọvemba 11, National Medical Product Administration nyere ọkwa iji wusie ogo nlekọta nke stent coronary ahọpụtara na ịzụ ahịa etiti mba;Na Nọvemba 25, National Medical Products Administration haziri ma kpọkọta ogbako vidiyo maka ịdịmma na nchekwa nchekwa nke stent coronary ahọpụtara na ịzụ ahịa etiti mba iji kwalite ogo na nchekwa nchekwa nke ngwaahịa ahọpụtara;Na December 10, Xu Jinghe, osote director nke National Medical Products Administration , duru otu nlekọta na nnyocha otu nnyocha na mmepụta àgwà management nke abụọ ahọrọ coronary stent emepụta na Beijing.
Isi mmalite: Ndị otu China maka ụlọ ọrụ ngwaọrụ ahụike
Oge nzipu: Mee-24-2021