Izindaba

Njengamanje, kunemishini yezokwelapha engaphezu kuka-10,000 emhlabeni wonke.1 Amazwe kufanele abeke ukuphepha kwesiguli kuqala futhi aqinisekise ukufinyelela kumishini yezokwelapha esezingeni eliphezulu, ephephile futhi esebenzayo.2,3 Imakethe yemishini yezokwelapha yaseLatin America iyaqhubeka nokukhula ngenani elibalulekile lokukhula lonyaka.Amazwe ase-Latin America nase-Caribbean adinga ukungenisa ngaphezu kuka-90% wemishini yezokwelapha ngenxa yokuthi ukukhiqizwa kwendawo kanye nokuhlinzekwa kwemishini yezokwelapha kubala ngaphansi kuka-10% wesamba esifunekayo.
I-Argentina iyizwe lesibili ngobukhulu eLatin America ngemuva kweBrazil.Njengoba kunabantu ababalelwa ezigidini ezingama-49, iyizwe lesine elinabantu abaningi esifundeni4, kanye nomnotho wesithathu ngobukhulu ngemuva kweBrazil neMexico, elinomkhiqizo kazwelonke (GNP) olinganiselwa ku-US$450 billion.Imali engenayo yonyaka ye-Argentina ngomuntu ngamunye ingu-US$22,140, ​​enye ephezulu kakhulu eLatin America.5
Le ndatshana ihlose ukuchaza umthamo wohlelo lwezempilo lwase-Argentina kanye nenethiwekhi yesibhedlela.Ngaphezu kwalokho, ihlaziya inhlangano, imisebenzi, nezici zokulawula zohlaka lokulawula lwedivayisi yezokwelapha yase-Argentina kanye nobudlelwano bayo ne-Mercado Común del Sur (Mercosur).Okokugcina, uma kucatshangelwa izimo zomnotho omkhulu nezenhlalo e-Argentina, ifingqa amathuba ebhizinisi nezinselelo ezimelelwe imakethe yemishini yase-Argentina.
Uhlelo lokunakekelwa kwezempilo lwase-Argentina luhlukaniswe ngamasistimu angaphansi amathathu: umphakathi, ukuphepha komphakathi kanye nobumfihlo.Umkhakha kahulumeni uhlanganisa ungqongqoshe kazwelonke nowezifundazwe, kanye noxhaxha lwezibhedlela zikahulumeni nezikhungo zezempilo, ezihlinzeka ngezinsizakalo zezokwelapha zamahhala kunoma ubani odinga ukunakekelwa kwamahhala, ngokuyisisekelo abantu abangafanelekile ukuvikeleka komphakathi futhi abangakwazi ukukhokha.Imali engenayo yezimali ihlinzeka ngezimali zohlelo oluncane lokunakekelwa kwezempilo komphakathi, futhi ithola izinkokhelo njalo kuhlelo olungaphansi lokuvikela umphakathi ukuze kuhlinzekwe izinsiza ezinkampanini eziphethwe.
Uhlelo olungaphansi lokuvikela umphakathi luyisibopho, lugxile “ku-obra sociales” (izinhlelo zezempilo zeqembu, i-OS), ukuqinisekisa nokuhlinzeka ngezinsizakalo zokunakekelwa kwezempilo kubasebenzi nemindeni yabo.Iminikelo evela kubasebenzi kanye nabaqashi babo ixhasa ama-OS amaningi, futhi basebenza ngezinkontileka nabathengisi abazimele.
Uhlelo olungaphansi oluzimele luhlanganisa ochwepheshe bezokunakekelwa kwempilo kanye nezikhungo zokunakekelwa kwezempilo ezelapha iziguli ezineholo eliphezulu, abahlomuli be-OS, kanye nabanikazi bomshwalense abazimele.Lolu hlelo oluncane luhlanganisa nezinkampani zomshwalense zokuzithandela ezibizwa ngezinkampani zomshwalense “zezidakamizwa ezikhokhelwa kuqala”.Ngokusebenzisa amaphrimiyamu omshwalense, abantu ngabanye, imindeni nabaqashi bahlinzeka ngemali yezinkampani zomshwalense wezokwelapha ezikhokhelwa kusengaphambili.Izibhedlela zikahulumeni eziyisi-7 zase-Argentina zibalelwa ku-51% yenani eliphelele lezibhedlela (cishe izi-2,300), ezikleliswe endaweni yesihlanu emazweni aseLatin America anezibhedlela eziningi zikahulumeni.Isilinganiso semibhede yasesibhedlela siyimibhede engu-5.0 ngezakhamuzi eziyi-1,000, ephakeme kakhulu kunesilinganiso esingu-4.7 emazweni e-Organisation for Economic Co-operation and Development (OECD).Ngaphezu kwalokho, i-Argentina inenani eliphakeme kakhulu lodokotela emhlabeni, elinezakhamuzi ezingu-4.2 ku-1,000, lidlula i-OECD 3.5 kanye nesilinganiso saseJalimane (4.0), iSpain ne-United Kingdom (3.0) namanye amazwe aseYurophu.8
I-Pan American Health Organization (PAHO) ifake ohlwini I-Argentina National Food, Drug and Medical Technology Administration (ANMAT) njengesikhungo sokulawula esinamazinga amane, okusho ukuthi singaqhathaniswa ne-US FDA.I-ANMAT inomthwalo wemfanelo wokwengamela nokuqinisekisa ukusebenza kahle, ukuphepha kanye nezinga eliphezulu lemithi, ukudla kanye nemishini yezokwelapha.I-ANMAT isebenzisa isistimu yokuhlukanisa esekelwe engcupheni efana naleyo esetshenziswa e-European Union nase-Canada ukuze iqondise ukugunyazwa, ukubhaliswa, ukugadwa, ukuqapha kanye nezici zezimali zemishini yezokwelapha ezweni lonke.I-ANMAT isebenzisa ukuhlukaniswa okusekelwe engozini, lapho izinto zezokwelapha zihlukaniswa ngezigaba ezine ngokusekelwe ezingozini ezingaba khona: I-Class I-ingozi ephansi kakhulu;I-Class II-ingozi ephakathi;I-Class III-ingozi ephezulu;kanye ne-Class IV-ingozi ephezulu kakhulu.Noma yimuphi umkhiqizi wangaphandle ofisa ukuthengisa izinto zokwelapha e-Argentina kufanele aqoke omele indawo ukuze ahambise amadokhumenti adingekayo ngenqubo yokubhalisa.Iphampu yokufaka, iphampu yesirinji kanye nephampu yokudla (iphampu yokudla) njengemishini yezokwelapha ye-calss IIb, kufanele idluliselwe ku-MDR Entsha ngo-2024.
Ngokwemithetho esebenzayo yokubhaliswa kwedivayisi yezokwelapha, abakhiqizi kufanele babe nehhovisi lendawo noma umsabalalisi obhaliswe noMnyango Wezempilo wase-Argentina ukuze bahambisane Nemikhuba Emihle Yokukhiqiza (i-BPM).Emadivaysi ezokwelapha e-Class III kanye ne-Class IV, abakhiqizi kufanele balethe imiphumela yesilingo somtholampilo ukuze bafakazele ukuphepha nokusebenza kocingo.I-ANMAT inezinsuku zokusebenza eziyi-110 zokuhlola idokhumenti futhi ikhiphe ukugunyazwa okuhambisanayo;kumadivayisi ezokwelapha e-Class I kanye ne-Class II, i-ANMAT inezinsuku zokusebenza eziyi-15 zokuhlola nokugunyaza.Ukubhaliswa komshini wezokwelapha kusebenza iminyaka emihlanu, futhi umenzi angakwazi ukuwubuyekeza izinsuku ezingu-30 ngaphambi kokuthi uphelelwe yisikhathi.Kunendlela yokubhalisa elula yezichibiyelo ezitifiketini zokubhalisa ze-ANMAT zemikhiqizo yesigaba III nese-IV, futhi impendulo inikezwa zingakapheli izinsuku zokusebenza eziyi-15 ngesimemezelo sokuthobela imithetho.Umkhiqizi kufanele futhi anikeze ngomlando ophelele wokuthengiswa kwangaphambilini kwedivayisi kwamanye amazwe.10
Njengoba i-Argentina iyingxenye ye-Mercado Común del Sur (Mercosur)-indawo yohwebo eyakhiwe i-Argentina, Brazil, Paraguay ne-Uruguay-zonke izisetshenziswa zezokwelapha ezingeniswa kwamanye amazwe zikhokhiswa intela ngokuvumelana ne-Mercosur Common External Tariff (CET).Izinga lentela lisukela ku-0% ukuya ku-16%.Endabeni yemishini yezokwelapha elungiswe kabusha engenisiwe, izinga lentela lisukela ku-0% ukuya ku-24%.10
Ubhubhane lwe-COVID-19 lube nomthelela omkhulu e-Argentina.12, 13, 14, 15, 16 Ngo-2020, umkhiqizo kazwelonke wezwe wehle ngo-9.9%, ukwehla okukhulu kakhulu eminyakeni eyi-10.Ngaphandle kwalokhu, umnotho wasekhaya ngo-2021 usazokhombisa ukungalingani okukhulu kwezomnotho omkhulu: yize uhulumeni elawula amanani entengo, izinga lokwehla kwamandla emali ngonyaka ka-2020 lisazofika ku-36%.6 Naphezu kwezinga eliphezulu lokwehla kwamandla emali kanye nokuwohloka komnotho, izibhedlela zase-Argentina zikhulise ukuthengwa kwazo kwemishini yezokwelapha eyisisekelo nekhethekile ngo-2020. Ukwanda kokuthengwa kwemishini yezokwelapha ekhethekile ngo-2020 kusukela ngo-2019 yilokhu: 17
Ngesikhathi esifanayo kusukela ngo-2019 kuya ku-2020, ukuthengwa kwemishini yezokwelapha eyisisekelo ezibhedlela zase-Argentina kunyukile: 17
Kuyathakazelisa ukuthi, uma kuqhathaniswa no-2019, kuzoba nokwenyuka kwezinhlobo ezimbalwa zemishini yezokwelapha ebizayo e-Argentina ngo-2020, ikakhulukazi ngonyaka lapho izinqubo zokuhlinza ezidinga lezi zisetshenziswa zakhanselwa noma zahlehliswa ngenxa ye-COVID-19.Isibikezelo sika-2023 sibonisa ukuthi izinga lokukhula elihlanganisiwe lonyaka (CAGR) lale mishini yezokwelapha elandelayo izokwenyuka:17
I-Argentina iyizwe elinesistimu yezokwelapha exubile, enabahlinzeki besevisi yezempilo abalawulwa uhulumeni nabazimele.Imakethe yayo yemishini yezokwelapha inikeza amathuba amahle kakhulu ebhizinisi ngoba i-Argentina idinga ukungenisa cishe yonke imikhiqizo yezokwelapha.Naphezu kokulawulwa okuqinile kwezimali, ukwehla kwamandla emali kanye nokutshalwa kwezimali okuphansi kwamanye amazwe,18 isidingo esikhulu samanje semishini yezokwelapha eyisisekelo nekhethekile evela kwamanye amazwe, izikhathi ezinengqondo zokugunyazwa okungokomthetho, ukuqeqeshwa kwezemfundo okusezingeni eliphezulu kochwepheshe bezempilo base-Argentina, kanye nekhono elihle kakhulu lezwe lasesibhedlela. indawo ekhangayo yabakhiqizi bemishini yezokwelapha abafisa ukwandisa umkhondo wabo e-Latin America.
1. I-Organización Panamericana de la Salud.I-Regulación de dispositivos médicos [I-inthanethi].2021 [icashunwe kusukela ngoMeyi 17, 2021].Itholakala ku: https://www3.paho.org/hq/index.php?option=com_content&view=article&id=3418:2010-medical-devices-regulation&Itemid=41722&lang=es
2. I-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-Caricobe / COVID-19]. cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. I-Organización Panamericana de la salud.Dispositivos médicos [Inthanethi].2021 [icashunwe kusukela ngoMeyi 17, 2021].Itholakala ku: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro.I-Argentina: Economía y demografía [I-inthanethi].2021 [icashunwe kusukela ngoMeyi 17, 2021].Itholakala ku: https://datosmacro.expansion.com/paises/argentina
5. Isazi sezibalo.Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet].2020. Itholakala ku-URL elandelayo: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
6. IBhange Lomhlaba.IBhange Lomhlaba lase-Argentina [Inthanethi].2021. Itholakala kuwebhusayithi elandelayo: https://www.worldbank.org/en/country/argentina/overview
7. Belló M, Becerril-Montekio VM.I-Sistema de salud yase-Argentina.Salud Publica Mex [I-inthanethi].2011;53: 96-109.Itholakala ku: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342011000800006
8. I-Corpart G. Latinoamérica es uno de los mercados hospitalarios másrobustos del mundo.Ulwazi Lwezempilo Lomhlaba Wonke [I-inthanethi].2018;itholakala ku: https://globalhealthintelligence.com/es/analisis-de-ghi/latinoamerica-es-uno-de-los-mercados-hospitalarios-mas-robustos-del-mundo/
9. UNgqongqoshe wase-Argentina u-Anmat.I-ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [I-inthanethi].2018. Itholakala ku: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. I-RegDesk.Uhlolojikelele lwemithetho yedivayisi yezokwelapha yase-Argentina [I-inthanethi].2019. Itholakala ku: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Umxhumanisi weKomidi Lobuchwepheshe Bezolimo.Productos médicos: normativas sobre habilitaciones, registro y trazabilidad [Internet].2021 [icashunwe kusukela ngoMeyi 18, 2021].Itholakala 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. Hlaziya ukulungela inhlekelele yasesibhedlela ngokusebenzisa indlela yokuthatha izinqumo enemibandela eminingi: Thatha izibhedlela zaseTurkey njengesibonelo.I-Int J Ukunciphisa Ingozi Yezinhlekelele [I-inthanethi].Julayi 2020;101748. Itholakala ku: 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, njll. Umthelela wobhubhane lwe-COVID-19 empilweni yengqondo yomphakathi: ukuphawula okulandisa okunabile.Ukusimama [I-inthanethi].Mashi 15 2021;13(6):3221.Itholakala ku: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
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15. I-Romo A, i-Ojeda-Galaviz C. Tango ye-COVID-19 idinga okungaphezu kokubili: ukuhlaziywa kwempendulo yobhubhane lwakuqala e-Argentina (Januwari 2020 kuya ku-April 2020).I-Int J Environ Res Public Health [I-inthanethi].Disemba 24, 2020;18(1):73.Itholakala ku: https://www.mdpi.com/1660-4601/18/1/73 doi: 10.3390/ijerph18010073
16. I-Bolaño-Ortiz TR, i-Puliafito SE, i-Berna-Peña LL, i-Pascual-Flores RM, i-Urquiza J, i-Camargo-Caicedo Y. Izinguquko ekukhiqizweni komkhathi nomthelela wazo wezomnotho phakathi nokuvalwa kobhubhane lwe-COVID-19 e-Argentina.Ukusimama [I-inthanethi].Okthoba 19, 2020;12(20): 8661. Itholakala ku: https://www.mdpi.com/2071-1050/12/20/8661 doi: 10.3390/su12208661
17. I-Corpart G. En Argentina ngo-2020, se dispararon las cantidades deequipos médicos especializados [Internet].2021 [icashunwe kusukela ngoMeyi 17, 2021].Itholakala ku: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
18. Otaola J, Bianchi W. Ukuwohloka komnotho wase-Argentina kwehle ngekota yesine;ukwehla komnotho unyaka wesithathu.AmaReuters [I-inthanethi].2021;Itholakala ku: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
U-Julio G. Martinez-Clark ungumsunguli kanye ne-CEO ye-bioaccess, inkampani yezeluleko yokufinyelela emakethe esebenza nezinkampani zemishini yezokwelapha ukuze izisize zenze ukuhlolwa komtholampilo okungenzeka kusenesikhathi futhi zidayise izinto ezintsha zazo e-Latin America.U-Julio futhi ungumsingathi we-podcast ye-LATAM Medtech Leaders: izingxoxo zamasonto onke nabaholi be-Medtech abaphumelelayo eLatin America.Uyilungu lebhodi labeluleki lohlelo oluphambili oluphazamisayo lweNyuvesi yaseStetson.Uneziqu ze-bachelor ku-electronic engineering kanye neziqu ze-master in Business Administration.