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Parizvino, kune michina yekurapa inodarika 10,000 pasi rose. 1 Nyika dzinofanira kuisa kuchengetedzeka kwevarwere pekutanga uye kuve nechokwadi chekuti vanowana michina yekurapa yepamusoro-soro, yakachengeteka uye inoshanda. 2,3 Musika wemidziyo yekurapa yeLatin America unoramba uchikura zvakanyanya pagore. Nyika dzeLatin America neCaribbean dzinofanirwa kutenga kunze kwenzvimbo inopfuura 90% yemidziyo yekurapa nekuti kugadzirwa kwemuno nekupihwa kwemidziyo yekurapa kunoderedza 10% yezvinodiwa zvavo zvese.
Argentina ndiyo nyika yechipiri pakukura muLatin America mushure meBrazil. Nehuwandu hwevanhu vanosvika mamiriyoni makumi mana nemapfumbamwe, ndiyo nyika yechina ine vanhu vakawanda mudunhu iri, uye yechitatu pakukura kwehupfumi mushure meBrazil neMexico, ine gross national product (GNP) inosvika mabhiriyoni emadhora ekuAmerica mazana mana nemakumi mashanu. Mari inowanikwa pagore yeArgentina pamunhu wega wega imadhora ekuAmerica zviuru makumi maviri nezviviri nemazana mana nemakumi mana, imwe yenzvimbo dzakakwirira muLatin America.
Chinyorwa chino chine chinangwa chekutsanangura kugona kwehurongwa hwehutano hweArgentina pamwe nehurongwa hwayo hwezvipatara. Pamusoro pezvo, chinoongorora kurongeka, mashandiro, uye hunhu hwemitemo yehurongwa hwemitemo yemidziyo yekurapa yeArgentina pamwe nehukama hwayo neMercado Común del Sur (Mercosur). Chekupedzisira, tichifunga nezvemamiriro ehupfumi hwenyika uye magariro evanhu muArgentina, chinopfupikisa mikana yebhizinesi nematambudziko aripo pari zvino mumusika wemidziyo yeArgentina.
Sisitimu yehutano yeArgentina yakakamurwa kuita masisitimu matatu: eruzhinji, ekuchengetedzwa kwevanhu uye epachivande. Chikamu chehurumende chinosanganisira madhipatimendi enyika neematunhu, pamwe netiweki yezvipatara zvehurumende nenzvimbo dzehutano, zvichipa rubatsiro rwekurapa mahara kune chero munhu anoda rubatsiro rwekurapa mahara, kunyanya vanhu vasingakodzeri kuwana rubatsiro rwevanhu uye vasingakwanise kubhadhara. Mari yezvemari inopa mari ye subsystem yehutano hweveruzhinji, uye inogamuchira mari nguva dzose kubva ku subsystem yekuchengetedza vanhu kuti ipe mabasa kune vanobatana nayo.
Sisitimu yekuchengetedzwa kwevanhu inosungirwa, yakatarisana ne "obra sociales" (zvirongwa zvehutano hweboka, OS), kuve nechokwadi nekupa masevhisi ehutano kuvashandi nemhuri dzavo. Mipiro kubva kuvashandi nevashandirwi vavo inobhadhara maOS mazhinji, uye anoshanda kuburikidza nezvibvumirano nevatengesi vega.
Sisitimu iyi yemunhu oga inosanganisira nyanzvi dzehutano nemasangano ehutano anorapa varwere vane mari yakawanda, vanobatsirwa neOS, uye vane inishuwarenzi yemunhu oga. Sisitimu iyi inosanganisirawo makambani einishuwarenzi anozvipira anonzi makambani einishuwarenzi e "prepaid drug". Kuburikidza nemari yeinishuwarenzi, vanhu, mhuri nevashandirwi vanopa mari kumakambani einishuwarenzi yekurapa anobhadharwa kare. Zvipatara zvehurumende zveArgentina zvinosvika 51% yehuwandu hwezvipatara zvayo (zvinosvika 2,300), zviri pachinzvimbo chechishanu pakati penyika dzeLatin America dzine zvipatara zvehurumende zvakawanda. Chiyero chemibhedha yezvipatara i5.0 mibhedha pavanhu 1,000, iyo yakakwira kupfuura avhareji ye4.7 munyika dzeOrganization for Economic Co-operation and Development (OECD). Pamusoro pezvo, Argentina ine imwe yenhamba yepamusoro yevanachiremba pasi rose, ine 4.2 pavanhu 1,000, ichipfuura OECD 3.5 uye avhareji yeGermany (4.0), Spain neUnited Kingdom (3.0) nedzimwe nyika dzeEurope. 8
Sangano rePan American Health Organisation (PAHO) rakanyora Argentine National Food, Drug and Medical Technology Administration (ANMAT) sesangano rine mazinga mana ekutonga, zvinoreva kuti rinogona kuenzaniswa neUS FDA. ANMAT ine basa rekutarisira nekuona kuti mishonga, chikafu, uye zvishandiso zvekurapa zvinoshanda zvakanaka uye zvine mhando yepamusoro. ANMAT inoshandisa nzira yekupatsanura mishonga, chikafu, uye zvishandiso zvekurapa ine njodzi yakafanana neyaishandiswa muEuropean Union neCanada kutarisira mvumo, kunyoresa, kutarisa, kutarisa, uye zvemari yemidziyo yekurapa munyika yese. ANMAT inoshandisa nzira yekupatsanura mishonga ine njodzi, umo michina yekurapa yakakamurwa kuita zvikamu zvina zvichienderana nenjodzi dzinogona kuitika: Kirasi I-njodzi yakaderera; Kirasi II-njodzi yepakati; Kirasi III-njodzi yepamusoro; uye Kirasi IV-njodzi huru kwazvo. Chero mugadziri wekunze anoda kutengesa michina yekurapa muArgentina anofanira kugadza mumiriri wemuno kuti atumire magwaro anodiwa pakunyoresa. Pombi yekuisa mushonga, pombi yesirinji uye pombi yekudya (pombi yekudyisa) semidziyo yekurapa yecalss IIb, inofanira kutapurirwa kuNew MDR panosvika 2024.
Zvichienderana nemitemo yekunyoresa michina yekurapa inoshanda, vagadziri vanofanirwa kuve nehofisi yemuno kana muparidzi akanyoreswa neArgentine Ministry of Health kuti vatevedzere Best Manufacturing Practices (BPM). Kune michina yekurapa yeClass III neClass IV, vagadziri vanofanirwa kutumira mhedzisiro yekuyedzwa kwekiriniki kuratidza kuchengetedzeka uye kushanda kwemuchina. ANMAT ine mazuva zana negumi ekushanda ekuongorora gwaro uye kupa mvumo inoenderana; kune michina yekurapa yeClass I neClass II, ANMAT ine mazuva gumi nemashanu ekushanda ekuongorora nekubvumidza. Kunyoreswa kwemuchina wekurapa kunoshanda kwemakore mashanu, uye mugadziri anogona kuugadzirisa mazuva makumi matatu usati wapera. Pane nzira iri nyore yekunyoresa yekugadzirisa zvitupa zvekunyoresa zveANMAT zvezvigadzirwa zveCategory III neIV, uye mhinduro inopihwa mukati memazuva gumi nemashanu ekushanda kuburikidza nekuzivisa kwekutevedzera mutemo. Mugadziri anofanirawo kupa nhoroondo yakazara yekutengesa kwemuchina kare mune dzimwe nyika. 10
Sezvo Argentina iri chikamu cheMercado Común del Sur (Mercosur) - nzvimbo yekutengeserana inoumbwa neArgentina, Brazil, Paraguay neUruguay - zvishandiso zvese zvekurapa zvinopinzwa zvinobhadhariswa mutero zvichienderana neMercosur Common External Tariff (CET). Mutero unotangira pa0% kusvika pa16%. Kana iri michina yekurapa yakagadziriswazve inopinzwa, mutero unotangira pa0% kusvika pa24%. 10
Denda reCOVID-19 rave nemhedzisiro yakakura kuArgentina. 12, 13, 14, 15, 16 Muna 2020, hupfumi hwenyika hwakaderera ne9.9%, kudzikira kukuru mumakore gumi. Pasinei neizvi, hupfumi hwenyika muna 2021 hucharamba huchiratidza kusawirirana kwakakomba kwehupfumi: kunyangwe hurumende ichidzora mitengo, mwero we inflation wepagore muna 2020 ucharamba wakakwira kusvika pa36%. 6 Pasinei ne inflation yakakwira uye kudzikira kwehupfumi, zvipatara zveArgentina zvakawedzera kutenga kwazvo michina yekurapa yakakosha uye yakasarudzika muna 2020. Kuwedzera kwekutenga michina yekurapa yakasarudzika muna 2020 kubva muna 2019 ndekwekuti: 17
Munguva imwe chete kubva muna 2019 kusvika 2020, kutenga michina yekurapa muzvipatara zveArgentina kwakawedzera: 17
Zvinofadza kuti, zvichienzaniswa negore ra2019, pachava nekuwedzera kwemhando dzakasiyana dzemidziyo yekurapa inodhura muArgentina muna 2020, kunyanya mugore iro nzira dzekuvhiya dzinoda michina iyi dzakamiswa kana kunonoka nekuda kweCOVID-19. Zvakafanotaurwa mugore ra2023 zvinoratidza kuti huwandu hwekuwedzera kwegore negore (CAGR) hwemidziyo yekurapa inotevera huchawedzera:17
Argentina inyika ine hurongwa hwakasiyana hwekurapa, ine vanopa rubatsiro rwehutano rweveruzhinji nevega vanotongwa nehurumende. Musika wayo wezvigadzirwa zvekurapa unopa mikana yakanaka yebhizinesi nekuti Argentina inoda kutenga zvigadzirwa zvekurapa zvese. Pasinei nekudzora kwakasimba kwemari, kukwira kwemitengo uye mari shoma yekudyara kunze kwenyika,18 kudiwa kwakanyanya kwemidziyo yekurapa inotengeswa kunze kwenyika uye yakasarudzika, nguva dzekubvumidzwa kwemitemo dzinonzwisisika, kudzidziswa kwepamusoro-soro kwenyanzvi dzehutano dzeArgentina, uye kugona kwakanaka kwezvipatara zvemunyika. Izvi zvinoita kuti Argentina ive nzvimbo inokwezva vagadziri vezvigadzirwa zvekurapa vanoda kuwedzera mukurumbira wavo muLatin America.
1. Organización Panamericana de la Salud. Regulación de dispositivos médicos [Internet]. 2021 [yakataurwa kubva muna Chivabvu 17, 2021]. Inowanikwa kubva: 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) en América Latina y el Caribe]. //repositorio.cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. Organización Panamericana de la salud. Dispositivos médicos [Internet]. 2021 [yakataurwa kubva muna Chivabvu 17, 2021]. Inowanikwa kubva: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro. Argentina: Economía y demografía [Internet]. 2021 [yakataurwa kubva muna Chivabvu 17, 2021]. Inowanikwa kubva: https://datosmacro.expansion.com/paises/argentina
5. Statistics. Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet]. 2020. Inowanikwa kubva kune inotevera URL: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
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9. Gurukota reArgentina Anmat. ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet]. 2018. Inowanikwa kubva: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. RegDesk. Pfupiso yemitemo yemidziyo yekurapa yeArgentina [Internet]. 2019. Inowanikwa kubva: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Murongi we Agricultural Technology Committee. Productos médicos: normativas sobre habilitaciones, registro y trazabilidad [Internet]. 2021 [yakataurwa kubva muna Chivabvu 18, 2021]. Inowanikwa kubva ku: http://www.cofybcf.org.ar/noticia_anterior.php?n=1805
12. Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. Ongorora kugadzirira njodzi muzvipatara uchishandisa nzira dzakasiyana-siyana dzekusarudza: Tora zvipatara zveTurkey semuenzaniso. Int J Disaster Risk Reduction [Internet]. Chikunguru 2020; 101748. Inowanikwa kubva: 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, nezvimwewo. Kukanganiswa kwedenda reCOVID-19 pahutano hwepfungwa dzeveruzhinji: tsananguro yakakura yenyaya. Kugara kwenguva refu [Internet]. Kurume 15 2021; 13(6):3221. Inowanikwa kubva: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
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. Sustainability [Internet]. Gumiguru 19, 2020; 12(20): 8661. Inowanikwa kubva: https://www.mdpi.com/2071-1050/12/20/8661 doi: 10.3390/su12208661
17. Corpart G. En Argentina muna 2020, se dispararon las cantidades deequipos médicos especializados [Internet]. 2021 [yakataurwa kubva muna Chivabvu 17, 2021]. Inowanikwa kubva: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
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Julio G. Martinez-Clark ndiye muvambi pamwe chete uye CEO we bioaccess, kambani inopa mazano ekuwana ruzivo rwemusika inoshanda nemakambani emidziyo yekurapa kuti avabatsire kuita miedzo yekiriniki yekutanga uye kutengeserana nehunyanzvi hwavo muLatin America. Julio ndiye zvakare mupi wepodcast yeLATAM Medtech Leaders: hurukuro dzevhiki nevhiki nevatungamiriri veMedtech vanobudirira muLatin America. Iye nhengo yebhodhi remazano rechirongwa cheStetson University chekuvandudza zvinhu zvitsva. Ane dhigirii reBachelor muEngineering yeElectronic uye dhigirii reMasters muBusiness Administration.