Wararka

Hadda, waxaa jira in ka badan 10,000 oo qalab caafimaad adduunka oo dhan.1 Wadamadu waa in ay marka hore badbaadiyaan bukaanka oo ay xaqiijiyaan helitaanka qalab caafimaad oo tayo sare leh, badbaado leh oo waxtar leh.2,3 Suuqa qalabka caafimaadka ee Latin Ameerika wuxuu ku sii socdaa inuu ku kordho heer kobac sanadle ah oo la taaban karo.Wadamada Laatiin Ameerika iyo Kariibiyaanka waxay u baahan yihiin inay soo dejiyaan in ka badan 90% aaladaha caafimaadka sababtoo ah wax soo saarka gudaha iyo sahayda aaladaha caafimaadka ayaa ah in ka yar 10% baahidooda guud.
Argentina waa dalka labaad ee ugu weyn Latin America marka laga reebo Brazil.Iyada oo ay ku nool yihiin ku dhawaad ​​​​49 milyan, waa dalka afraad ee ugu dadka badan gobolka4, iyo dhaqaalaha saddexaad ee ugu weyn ka dib Brazil iyo Mexico, oo leh wax soo saarka guud ee qaranka (GNP) oo ku dhow US$450 bilyan.Dakhliga Argentina qofkiiba sanadkii waa US$22,140, ​​waana mid ka mid ah kuwa ugu sarreeya Latin America.5
Maqaalkani waxa uu ujeedadiisu tahay in lagu qeexo awoodda nidaamka daryeelka caafimaadka Argentina iyo shabakadeeda isbitaalka.Intaa waxaa dheer, waxay falanqeyneysaa abaabulka, shaqooyinka, iyo sifooyinka sharciyeynta ee qaabka nidaaminta qalabka caafimaadka Argentine iyo xiriirka ay la leedahay Mercado Común del Sur (Mercosur).Ugu dambeyntiina, iyadoo la tixgelinayo xaaladaha dhaqaale-dhaqaale iyo bulsho ee Argentina, waxay soo koobeysaa fursadaha ganacsi iyo caqabadaha hadda ay matalaan suuqa qalabka Argentine.
Nidaamka daryeelka caafimaadka Argentina waxa uu u qaybsan yahay saddex hab-hoosaadyo: dadwaynaha, badbaadada bulshada iyo kuwa gaarka ah.Hay’adaha dawliga ah waxa ka mid ah wasaaradaha qaranka iyo kuwa gobolka iyo sidoo kale isku xidhka cusbitaalada guud iyo xarumaha caafimaadka, kuwaas oo bixiya adeeg caafimaad oo lacag la’aan ah qof kasta oo u baahan daryeel caafimaad oo bilaash ah, asal ahaan dadka aan xaq u lahayn ilaalinta bulshada oo aan awoodin inay iska bixiyaan lacag.Dakhliga maaliyadeed wuxuu bixiyaa lacag loogu talagalay nidaamka-hoosaadka daryeelka caafimaadka dadweynaha, wuxuuna ka helaa lacag-bixinno joogto ah nidaamka-hoosaadka badbaadada bulshada si uu u bixiyo adeegyada la-hawlgalayaasheeda.
Nadaamka badbaadada bulshada waa qasab, oo ku salaysan "obra sociales" (qorshayaasha caafimaadka kooxda, OS), hubinta iyo bixinta adeegyada daryeelka caafimaadka shaqaalaha iyo qoysaskooda.Deeqaha laga helo shaqaalaha iyo loo-shaqeeyayaashooda ayaa maalgeliya OS-yada intooda badan, waxayna ku shaqeeyaan qandaraasyo ay la leeyihiin iibiyeyaasha gaarka ah.
Nidaamka hoose ee gaarka ah waxaa ka mid ah xirfadlayaasha daryeelka caafimaadka iyo machadyada daryeelka caafimaadka kuwaas oo daaweeya bukaannada dakhligoodu sarreeyo, ka faa'iidaystayaasha OS, iyo kuwa haysta caymiska gaarka ah.Nidaamkan hoose waxa kale oo ka mid ah shirkado caymis oo iskaa wax u qabso ah oo loo yaqaan shirkadaha caymiska "daroogada horay loo sii bixiyey".Iyadoo loo marayo khidmadaha caymiska, shakhsiyaadka, qoysaska iyo loo-shaqeeyayaasha waxay bixiyaan lacag shirkadaha caymiska caafimaadka ee horay loo sii bixiyay.7 cosbitaalada guud ee Argentine ayaa ah 51% tirada guud ee cosbitaalada (qiyaastii 2,300), oo kaalinta shanaad ka galay wadamada Latin America ee leh cosbitaalada ugu badan.Saamiga sariiraha isbitaalku waa 5.0 sariirood 1,000kii qof ee deggan, taas oo xitaa ka sarraysa celceliska 4.7 ee wadamada Ururka Iskaashiga Dhaqaalaha iyo Horumarinta (OECD).Intaa waxaa dheer, Argentina waxay leedahay mid ka mid ah qaybaha ugu sarreeya ee dhakhaatiirta adduunka, oo leh 4.2 1,000 qof oo deggan, oo ka sarreeya OECD 3.5 iyo celceliska Jarmalka (4.0), Spain iyo Boqortooyada Ingiriiska (3.0) iyo dalalka kale ee Yurub.8
Ururka Caafimaadka Maraykanka ee Pan American (PAHO) ayaa liiska maamulka Cunnada, Dawooyinka iyo Tignoolajiyada Caafimaadka Qaranka Argentine (ANMAT) u taxay hay'ad sharci oo afar heer ah, taas oo macnaheedu yahay inay la barbar dhigi karto US FDA.ANMAT waxay mas'uul ka tahay ilaalinta iyo hubinta waxtarka, badbaadada iyo tayada sare ee daawooyinka, cuntada iyo qalabka caafimaadka.ANMAT waxay isticmaashaa nidaam kala soocida khatarta ku salaysan oo la mid ah ka lagu isticmaalo Midowga Yurub iyo Kanada si ay u kormeerto oggolaanshaha, diiwaangelinta, kormeerka, la socodka iyo qaybaha maaliyadeed ee qalabka caafimaadka waddanka oo dhan.ANMAT waxay isticmaashaa kala saarid ku salaysan khatarta, taas oo qalabka caafimaadka loo qaybiyay afar qaybood oo ku salaysan khataraha iman kara: Heerka I-khatarta ugu yar;Heerka II-khatarta dhexe;Heerka III-khatarta sare;iyo Fasalka IV-khatar aad u sareysa.Soo-saare kasta oo ajnabi ah oo raba inuu ku iibiyo qalabka caafimaadka ee Argentina waa inuu magacaabo wakiil maxalli ah si uu u soo gudbiyo dukumeentiyada looga baahan yahay habka diiwaangelinta.Bamka faleebo, bamka saliingaha iyo bamka nafaqeynta (bamka quudinta) sida calss IIb qalabka caafimaadka, waa in loo gudbiyaa MDR Cusub 2024
Marka loo eego qawaaniinta diiwaan gelinta qalabka caafimaadka, soosaarayaashu waa inay lahaadaan xafiis maxalli ah ama qaybiye ka diiwaan gashan Wasaaradda Caafimaadka Argentina si ay ugu hoggaansamaan Hababka Wax-soo-saarka ugu Fiican (BPM).Qalabka caafimaadka ee Fasalka III iyo Fasalka IV, soosaarayaashu waa inay soo gudbiyaan natiijooyinka tijaabada caafimaad si loo caddeeyo badbaadada iyo waxtarka aaladda.ANMAT waxay haysataa 110 maalmood oo shaqo si ay u qiimayso dukumeentiga oo ay u bixiso oggolaanshaha u dhigma;Aaladaha caafimaadka ee Class I iyo Class II, ANMAT waxay haysataa 15 maalmood oo shaqo si ay u qiimeyso oo loo ansixiyo.Diiwaangelinta aaladda caafimaadku waxay shaqaynaysaa shan sano, soo-saaruhuna wuxuu cusbooneysiin karaa 30 maalmood kahor intuusan dhicin.Waxaa jira hab fudud oo isdiiwaangelin ah oo loogu talagalay wax ka beddelka shahaadooyinka diiwaangelinta ANMAT ee alaabada qaybta III iyo IV, waxaana jawaabta lagu bixiyaa 15 maalmood oo shaqo gudahood iyada oo loo marayo caddaynta u hoggaansanaanta.Soo-saaruhu waa inuu sidoo kale bixiyaa taariikh dhamaystiran oo ku saabsan iibkii hore ee aaladda ee wadamada kale.10
Maadaama Argentina ay ka tirsan tahay Mercado Común del Sur (Mercosur) -waa aag ganacsi oo ka kooban Argentina, Brazil, Paraguay iyo Uruguay-dhammaan agabka caafimaadka ee dibadda laga keeno waxaa lagu canshuuraa si waafaqsan Mercosur Common External Tariff (CET).Heerka cashuurtu waxa uu u dhexeeyaa 0% ilaa 16%.Marka laga hadlayo aaladaha caafimaadka ee dib loo habeeyey, heerka cashuurtu waxa uu u dhexeeyaa 0% ilaa 24%.10
Faafida COVID-19 waxay saameyn weyn ku yeelatay Argentina.12, 13, 14, 15, 16 Sannadka 2020, wax soo saarka guud ee dalka ayaa hoos u dhacay 9.9%, hoos u dhacii ugu weynaa muddo 10 sano ah.Iyada oo ay taasi jirto, dhaqaalaha gudaha ee 2021 ayaa wali muujin doona isu dheelitir la'aanta dhaqaale ee daran: in kasta oo ay dawladdu xakamaynayso qiimaha, heerka sicir-bararka sanadlaha ah ee 2020 ayaa wali noqon doona ilaa 36%.6 Inkasta oo heerka sicir-bararka sareeyo iyo hoos u dhaca dhaqaalaha, isbitaallada Argentine waxay kordhiyeen iibsashada qalabyada aasaasiga ah iyo kuwa aadka u gaarka ah ee 2020. Korodhka iibsashada qalabka caafimaadka gaarka ah ee 2020 laga bilaabo 2019 waa: 17
Isla waqtigaas laga bilaabo 2019 ilaa 2020, iibsashada qalabka caafimaadka aasaasiga ah ee isbitaallada Argentine ayaa kordhay: 17
Waxa xiisaha lihi leh, marka la barbar dhigo 2019, waxaa jiri doona kor u kaca noocyo kala duwan oo qalab caafimaad oo qaali ah gudaha Argentina sanadka 2020, gaar ahaan sanadka marka hababka qalliinka ee u baahan qalabkan la joojiyay ama dib loo dhigay COVID-19 dartiis.Saadaasha 2023 waxay muujineysaa in heerka kobaca sanadlaha ee isku dhafka ah (CAGR) ee qalabkan caafimaad ee xirfadlayaasha ah uu kordhin doono:17
Argentina waa waddan leh nidaam caafimaad oo isku dhafan, oo leh bixiyeyaasha adeegga caafimaadka dadweynaha iyo kuwa gaarka ah ee ay dawladdu maamusho.Suuqa aaladeeda caafimaadka ayaa bixisa fursado ganacsi oo aad u wanaagsan sababtoo ah Argentina waxay u baahan tahay inay soo dejiso ku dhawaad ​​dhammaan alaabada caafimaadka.In kasta oo ay jiraan kontaroolo adag oo lacag ah, sicir barar sare iyo maalgashi shisheeye oo hooseeya,18 baahida sare ee hadda jirta ee agabka caafimaadka aasaasiga ah iyo kuwa gaarka ah ee dibedda laga keeno, jadwal oggolaansho sharci oo macquul ah, tababar tacliin heer sare ah oo xirfadlayaasha daryeelka caafimaadka Argentine, iyo awoodaha cusbitaalka ee ugu wanaagsan dalka Tani waxay ka dhigaysaa Argentina meel soo jiidasho leh oo loogu talagalay soosaarayaasha qalabka caafimaadka ee raba inay ballaariyaan raadkooda Latin America.
1. Organización Panamericana de la Salud.Regulación de dispositivos médicos [Internet].2021 [laga soo xigtay May 17, 2021].Waxaa laga heli karaa: https://www3.paho.org/hq/index.php?option=com_content&view=article&id=3418:2010-medical-devices-regulation&Itemid=41722&lang=es
2. Comisión Económica para América Latina y el Caribe (CEPAL. Las restricciones a la exportación de productos médicos dificultan los esfuerzos por contener la enfermedad porcoronavirus (COVID-19) iyo América Latina y el Caribe //COVID-19]. cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. Organización Panamericana de la salud.Dispositivos médicos [Internet].2021 [laga soo xigtay May 17, 2021].Waxaa laga heli karaa: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro.Argentina: Economía y demografia [Internet].2021 [laga soo xigtay May 17, 2021].Waxaa laga heli karaa: https://datosmacro.expansion.com/paises/argentina
5. Tirakoobka.Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet].2020. Waxaa laga heli karaa URL soo socda: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
6. Bangiga Adduunka.Bangiga Adduunka ee Argentina [Internet].2021. Waxaa laga heli karaa website-ka soo socda: https://www.worldbank.org/en/country/argentina/overview
7. Bello M, Becerril-Montekio VM.Sistema de salud de Argentina.Salud Publica Mex [Internet].2011;53: 96-109.Waxaa laga heli karaa: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342011000800006
8. Corpart G. Latinoamérica es uno de los mercados hospitalarios másrobustos del mundo.Macluumaadka Caafimaadka Caalamiga ah [Internet].2018;Waxaa laga heli karaa: https://globalhealthintelligence.com/es/analisis-de-ghi/latinoamerica-es-uno-de-los-mercados-hospitalarios-mas-robustos-del-mundo/
9. Wasiirka Arjantiin Anmat.ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet].2018. Waxaa laga heli karaa: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. RegDesk.Dulmar guud oo ku saabsan xeerarka qalabka caafimaadka Argentina [Internet].2019. Waxaa laga heli karaa: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Isuduwaha Guddida Tignoolajiyada Beeraha.Productos médicos: normativas sobre habilitaciones, registro iyo trazabilidad [Internet].2021 [laga soo xigtay May 18, 2021].Waxaa laga heli karaa: http://www.cofybcf.org.ar/noticia_anterior.php?n=1805
12. Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. Qiimee u diyaargarowga musiibada isbitaalka iyadoo loo marayo hab go'aan qaadasho oo shuruudo badan leh: U qaado cisbitaalada Turkiga tusaale ahaan.Int J Yaraynta Khatarta Musiibada [Internet].Luulyo 2020;101748. Waxaa laga heli karaa: https://linkinghub.elsevier.com/retrieve/pii/S221242092030354X doi: 10.1016/j.ijdrr.2020.101748
13. Clemente-Suárez VJ, Navarro-Jiménez E, Jimenez M, Hormeño-Holgado A, Martinez-Gonzalez MB, Benitez-Agudelo JC, iwm. Saamaynta masiibada COVID-19 ee caafimaadka maskaxda dadweynaha: faallo sheeko dheerSustainability [Internet].Maarso 15 2021;13(6):3221.Waxaa laga heli karaa: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
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15. Romo A, Ojeda-Galaviz C. Tango ee COVID-19 waxay u baahan tahay in ka badan laba: falanqaynta jawaabta hore ee masiibada ee Argentina (Janaayo 2020 ilaa Abriil 2020).Int J Environ Res Caafimaadka Dadweynaha [Internet].Diseembar 24, 2020;18(1):73.Waxaa laga heli karaa: https://www.mdpi.com/1660-4601/18/1/73 doi: 10.3390/ijerph18010073
16. Bolaño-Ortiz TR, Puliafito SE, Berná-Peña LL, Pascual-Flores RM, Urquiza J, Camargo-Caicedo Y. Isbeddellada ku yimaadda qiiqa hawada iyo saameyntooda dhaqaale inta lagu jiro xannibaadda faafa ee COVID-19 ee Argentina.Sustainability [Internet].Oktoobar 19, 2020;12 (20): 8661. Waxaa laga heli karaa: https://www.mdpi.com/2071-1050/12/20/8661 doi: 10.3390/su12208661
17. Corpart G. En Argentina en 2020, se dispararon las cantidades deequipos médicos especializados [Internet].2021 [laga soo xigtay May 17, 2021].Waxaa laga heli karaa: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
18. Otaola J, Bianchi W. Dhaqaalaha Argentina ayaa hoos u dhacay rubuci afraad;hoos u dhaca dhaqaale waa sanadkii saddexaad.Reuters [Internet].2021;Waxaa laga heli karaa: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
Julio G. Martinez-Clark waa aasaasaha iyo maamulaha bioaccess, oo ah shirkad la-talin suuq-gelis ah oo la shaqeysa shirkadaha aaladaha caafimaadka si ay uga caawiso inay qabtaan tijaabooyin caafimaad oo suurtagal ah goor hore oo ay ganacsiyeeyaan hal-abuurkooda Latin America.Julio sidoo kale waa martigeliyaha LATAM Hogaamiyaasha Medtech podcast: wadahadal todobaadle ah oo lala yeesho hogaamiyaasha Medtech ee ku guulaystay Latin America.Waa xubin ka mid ah guddiga la-talinta ee Jaamacadda Stetson barnaamijkeeda hal-abuurka ee hormuudka ka ah.Waxa uu shahaadada koowaad ee jaamacadda ku diyaariyay injineernimada elektaroonigga ah iyo shahaadada mastarka ee maamulka ganacsiga.