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Pakadali pano, pali zipangizo zachipatala zoposa 10,000 padziko lonse lapansi. 1 Mayiko ayenera kuyika chitetezo cha odwala patsogolo ndikuwonetsetsa kuti zipangizo zachipatala zapamwamba, zotetezeka komanso zogwira mtima zikupezeka. 2,3 Msika wa zipangizo zachipatala ku Latin America ukupitirira kukula pamlingo wokulirapo pachaka. Mayiko aku Latin America ndi Caribbean akuyenera kutumiza kunja zoposa 90% ya zipangizo zachipatala chifukwa kupanga ndi kupereka zipangizo zachipatala m'deralo kumawononga ndalama zosakwana 10% ya zomwe akufuna.
Argentina ndi dziko lachiwiri lalikulu kwambiri ku Latin America pambuyo pa Brazil. Ndi anthu pafupifupi 49 miliyoni, ndi dziko lachinayi lomwe lili ndi anthu ambiri m'chigawochi4, komanso lachitatu lalikulu kwambiri pambuyo pa Brazil ndi Mexico, lomwe lili ndi phindu lonse la dziko (GNP) la pafupifupi US$450 biliyoni. Ndalama zomwe munthu aliyense amapeza pachaka ku Argentina ndi US$22,140, ​​imodzi mwa ndalama zambiri ku Latin America. 5
Nkhaniyi ikufuna kufotokoza mphamvu ya dongosolo lazaumoyo ku Argentina ndi netiweki yake ya zipatala. Kuphatikiza apo, ikuwunikanso kayendetsedwe kake, ntchito zake, ndi machitidwe a dongosolo lolamulira zida zamankhwala ku Argentina komanso ubale wake ndi Mercado Común del Sur (Mercosur). Pomaliza, poganizira za momwe zinthu zilili pazachuma komanso chikhalidwe cha anthu ku Argentina, ikufotokoza mwachidule mwayi wamabizinesi ndi zovuta zomwe zikuyimiridwa ndi msika wa zida ku Argentina.
Dongosolo lazaumoyo ku Argentina lagawidwa m'magulu atatu: boma, chitetezo cha anthu ndi zachinsinsi. Gawo la boma limaphatikizapo mautumiki adziko lonse ndi a zigawo, komanso netiweki ya zipatala za boma ndi malo azaumoyo, zomwe zimapereka chithandizo chamankhwala chaulere kwa aliyense amene akufunika chithandizo chamankhwala chaulere, makamaka anthu omwe sali oyenerera kulandira chitetezo cha anthu ndipo sangathe kulipira. Ndalama zandalama zimapereka ndalama ku dongosolo lazaumoyo la anthu, ndipo zimalandira malipiro nthawi zonse kuchokera ku dongosolo lazachitetezo cha anthu kuti lipereke chithandizo kwa mabungwe omwe ali m'bungweli.
Dongosolo la chitetezo cha anthu ndi lofunikira, lokhazikika pa "obra sociales" (mapulani azaumoyo amagulu, OS), kuonetsetsa ndikupereka chithandizo chaumoyo kwa ogwira ntchito ndi mabanja awo. Zopereka kuchokera kwa ogwira ntchito ndi owalemba ntchito awo zimathandizira ma OS ambiri, ndipo amagwira ntchito kudzera m'mapangano ndi ogulitsa achinsinsi.
Dongosolo laling'ono lachinsinsi limaphatikizapo akatswiri azaumoyo ndi mabungwe azaumoyo omwe amathandizira odwala omwe ali ndi ndalama zambiri, opindula ndi OS, ndi omwe ali ndi inshuwaransi yachinsinsi. Dongosolo laling'onoli limaphatikizaponso makampani a inshuwaransi odzifunira otchedwa makampani a inshuwaransi "olipira kale mankhwala". Kudzera mu ndalama za inshuwaransi, anthu, mabanja ndi olemba ntchito amapereka ndalama kumakampani a inshuwaransi yachipatala yolipira kale. Zipatala 7 za boma ku Argentina zimakhala ndi 51% ya zipatala zake zonse (pafupifupi 2,300), zomwe zili pa nambala 5 pakati pa mayiko aku Latin America omwe ali ndi zipatala zambiri za boma. Chiŵerengero cha mabedi azachipatala ndi mabedi 5.0 pa anthu 1,000, zomwe ndi zapamwamba kwambiri kuposa avareji ya 4.7 m'maiko a Organization for Economic Co-operation and Development (OECD). Kuphatikiza apo, Argentina ili ndi chimodzi mwa ziwerengero zapamwamba kwambiri za madokotala padziko lonse lapansi, ndi 4.2 pa anthu 1,000, kupitirira OECD 3.5 ndi avareji ya Germany (4.0), Spain ndi United Kingdom (3.0) ndi mayiko ena aku Europe. 8
Bungwe la Pan American Health Organisation (PAHO) lalemba bungwe la Argentina National Food, Drug and Medical Technology Administration (ANMAT) ngati bungwe loyang'anira zinthu zinayi, zomwe zikutanthauza kuti lingafanane ndi US FDA. ANMAT ili ndi udindo woyang'anira ndikuwonetsetsa kuti mankhwala, chakudya ndi zipangizo zachipatala zikugwira ntchito bwino, zili bwino komanso zili bwino. ANMAT imagwiritsa ntchito njira yogawa mankhwala yofanana ndi yomwe imagwiritsidwa ntchito ku European Union ndi Canada kuyang'anira chilolezo, kulembetsa, kuyang'anira, kuyang'anira komanso ndalama za zipangizo zachipatala mdziko lonse. ANMAT imagwiritsa ntchito njira yogawa mankhwala yofanana ndi yomwe imagwiritsidwa ntchito ku European Union ndi Canada kuyang'anira kuvomereza, kulembetsa, kuyang'anira, kuyang'anira komanso zachuma za zipangizo zachipatala mdziko lonse. ANMAT imagwiritsa ntchito njira yogawa mankhwala yofanana ndi yomwe ili ndi chiopsezo, momwe zipangizo zachipatala zimagawidwa m'magulu anayi kutengera zoopsa zomwe zingachitike: Gulu I - chiopsezo chotsika kwambiri; Gulu II - chiopsezo chapakati; Gulu III - chiopsezo chachikulu; ndi Gulu IV - chiopsezo chachikulu kwambiri. Wopanga aliyense wakunja amene akufuna kugulitsa zipangizo zachipatala ku Argentina ayenera kusankha woimira wakomweko kuti apereke zikalata zofunika pakulembetsa. Pampu yolowetsera mankhwala, pampu ya syringe ndi pampu yopatsa thanzi (pampu yodyetsa) ngati zida zachipatala za calss IIb, ziyenera kutumizidwa ku MDR Yatsopano pofika chaka cha 2024.
Malinga ndi malamulo ogwiritsira ntchito kulembetsa zida zachipatala, opanga ayenera kukhala ndi ofesi kapena wogulitsa wapafupi wolembetsedwa ndi Unduna wa Zaumoyo ku Argentina kuti atsatire Malamulo Abwino Opangira (BPM). Pa zida zachipatala za Gulu lachitatu ndi lachinayi, opanga ayenera kupereka zotsatira za mayeso azachipatala kuti atsimikizire chitetezo ndi kugwira ntchito kwa chipangizocho. ANMAT ili ndi masiku 110 ogwira ntchito kuti iwunike chikalatacho ndikupereka chilolezo chofanana; pa zida zachipatala za Gulu la I ndi lachiwiri, ANMAT ili ndi masiku 15 ogwira ntchito kuti iwunike ndikuvomereza. Kulembetsa chipangizo chachipatala kumakhala kovomerezeka kwa zaka zisanu, ndipo wopanga akhoza kuchisintha masiku 30 chisanathe. Pali njira yosavuta yolembetsera yosinthira satifiketi yolembetsa ya ANMAT ya zinthu za gulu lachitatu ndi lachinayi, ndipo yankho limaperekedwa mkati mwa masiku 15 ogwira ntchito kudzera mu kulengeza kuti zikutsatira malamulo. Wopanga ayeneranso kupereka mbiri yonse ya malonda am'mbuyomu a chipangizocho m'maiko ena. 10
Popeza Argentina ndi gawo la Mercado Común del Sur (Mercosur) - dera logulitsira lomwe lili ndi Argentina, Brazil, Paraguay ndi Uruguay - zida zonse zamankhwala zomwe zimatumizidwa kunja zimakhomeredwa msonkho motsatira Mercosur Common External Tariff (CET). Mtengo wa msonkho umayambira pa 0% mpaka 16%. Pankhani ya zida zachipatala zokonzedwanso zomwe zimatumizidwa kunja, msonkho umayambira pa 0% mpaka 24%. 10
Mliri wa COVID-19 wakhudza kwambiri dziko la Argentina. 12, 13, 14, 15, 16 Mu 2020, chuma cha dziko lonse chatsika ndi 9.9%, kutsika kwakukulu kwambiri m'zaka 10. Ngakhale izi zili choncho, chuma cha dzikolo mu 2021 chidzawonetsabe kusalingana kwakukulu kwachuma: ngakhale boma likulamulira mitengo, kukwera kwa mitengo pachaka mu 2020 kudzakhalabe kokwera mpaka 36%. 6 Ngakhale kukwera kwa mitengo komanso kutsika kwachuma, zipatala zaku Argentina zawonjezera kugula kwawo zida zamankhwala zoyambira komanso zapadera kwambiri mu 2020. Kuwonjezeka kwa kugula zida zachipatala zapadera mu 2020 kuyambira 2019 ndi: 17
Munthawi yomweyi kuyambira 2019 mpaka 2020, kugula zida zoyambira zachipatala m'zipatala zaku Argentina kwawonjezeka: 17
Chochititsa chidwi n'chakuti, poyerekeza ndi chaka cha 2019, padzakhala kuwonjezeka kwa mitundu ingapo ya zida zachipatala zodula ku Argentina mu 2020, makamaka m'chaka chomwe njira zopangira opaleshoni zomwe zimafuna zidazi zinathetsedwa kapena kuimitsidwa chifukwa cha COVID-19. Zoneneratu za 2023 zikuwonetsa kuti kuchuluka kwa kukula kwa pachaka (CAGR) kwa zida zachipatala zotsatirazi kudzawonjezeka:17
Argentina ndi dziko lomwe lili ndi njira zosiyanasiyana zachipatala, lokhala ndi opereka chithandizo chamankhwala cha boma komanso chachinsinsi omwe amalamulidwa ndi boma. Msika wake wa zida zamankhwala umapereka mwayi wabwino kwambiri wamabizinesi chifukwa Argentina ikufunika kutumiza zinthu zonse zachipatala kunja. Ngakhale kuti ndalama zake zimayendetsedwa molimbika, kukwera kwa mitengo komanso ndalama zochepa zakunja,18 kufunikira kwakukulu kwa zida zamankhwala zoyambira komanso zapadera zomwe zimatumizidwa kunja, nthawi yovomerezeka yovomerezeka ndi malamulo, maphunziro apamwamba a akatswiri azaumoyo aku Argentina, komanso luso labwino kwambiri la zipatala mdzikolo. Izi zimapangitsa Argentina kukhala malo abwino kwambiri kwa opanga zida zamankhwala omwe akufuna kukulitsa malo awo ku Latin America.
1. Organización Panamericana de la Salud. Regulación de dispositivos médicos [Internet]. 2021 [kuchokera pa Meyi 17, 2021]. Kuchokera ku: 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 [Intaneti]. 2021 [kuchokera pa Meyi 17, 2021]. Ipezeka kuchokera: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos zazikulu. Argentina: Economía y demografía [Intaneti]. 2021 [kuchokera pa Meyi 17, 2021]. Ipezeka kuchokera: https://datosmacro.expansion.com/paises/argentina
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9. Mtumiki waku Argentina Anmat. ANMAT yotsogola por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet]. 2018. Ipezeka kuchokera: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
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Julio G. Martinez-Clark ndi m'modzi mwa omwe adayambitsa komanso CEO wa bioaccess, kampani yopereka upangiri wokhudza kupeza zinthu pamsika yomwe imagwira ntchito ndi makampani opanga zida zamankhwala kuti awathandize kuchita mayeso azachipatala oyambilira ndikugulitsa zatsopano zawo ku Latin America. Julio ndiyenso wotsogolera pulogalamu ya LATAM Medtech Leaders: zokambirana za sabata iliyonse ndi atsogoleri opambana a Medtech ku Latin America. Ndi membala wa bungwe lolangiza la pulogalamu yotsogola yosokoneza ya Stetson University. Ali ndi digiri ya bachelor mu uinjiniya wamagetsi komanso digiri ya master mu kayendetsedwe ka bizinesi.


Nthawi yotumizira: Sep-06-2021