Labarai

A halin yanzu, akwai na'urorin kiwon lafiya sama da 10,000 a duk duniya.1 Dole ne ƙasashe su sanya amincin marasa lafiya a farko kuma su tabbatar da samun ingantattun na'urorin kiwon lafiya masu inganci, aminci da inganci.2,3 Kasuwancin kayan aikin likitancin Latin Amurka yana ci gaba da girma a cikin ƙimar girma na shekara-shekara.Kasashen Latin Amurka da Caribbean suna buƙatar shigo da sama da kashi 90% na na'urorin likitanci saboda samarwa da samar da na'urorin likitanci na cikin gida suna da ƙasa da 10% na jimlar buƙatun su.
Argentina ita ce kasa ta biyu mafi girma a Latin Amurka bayan Brazil.Tare da yawan jama'a kusan miliyan 49, ita ce ƙasa ta huɗu mafi yawan jama'a a yankin4, kuma ƙasa ta uku mafi girman tattalin arziki bayan Brazil da Mexico, tare da babban samfurin ƙasa (GNP) na kusan dalar Amurka biliyan 450.Yawan kudin shiga na kowane mutum na kowace shekara shine dalar Amurka 22,140, ​​ɗayan mafi girma a Latin Amurka.5
Wannan labarin yana da nufin bayyana ƙarfin tsarin kiwon lafiyar Argentina da cibiyar sadarwar asibiti.Bugu da ƙari, yana nazarin tsari, ayyuka, da halaye na tsarin tsarin tsarin na'urar likitancin Argentine da dangantakarta da Mercado Común del Sur (Mercosur).A ƙarshe, la'akari da yanayin tattalin arziki da zamantakewa a Argentina, yana taƙaita damar kasuwanci da ƙalubalen da kasuwar kayan aikin Argentine ke wakilta a halin yanzu.
Tsarin kiwon lafiyar Argentina ya kasu kashi uku: jama'a, tsaro na zamantakewa da masu zaman kansu.Bangaren gwamnati ya hada da ma’aikatun kasa da na larduna, da kuma hadaddiyar asibitocin gwamnati da cibiyoyin kiwon lafiya, da samar da ayyukan jinya kyauta ga duk wanda ke bukatar kulawar jinya kyauta, musamman mutanen da ba su cancanci jin dadin jama’a ba kuma ba za su iya biya ba.Kudaden shiga na kasafin kudi yana ba da kuɗi don tsarin kula da lafiyar jama'a, kuma yana karɓar biyan kuɗi na yau da kullun daga tsarin tsaro na zamantakewa don ba da sabis ga abokan haɗin gwiwa.
Tsarin tsarin tsaro na zamantakewa ya zama dole, wanda ya dogara da "obra sociales" (tsare-tsaren kiwon lafiya na rukuni, OS), tabbatarwa da samar da sabis na kiwon lafiya ga ma'aikata da iyalansu.Gudunmawa daga ma'aikata da ma'aikatansu suna tallafawa yawancin OSs, kuma suna aiki ta hanyar kwangila tare da dillalai masu zaman kansu.
Tsarin ƙasa mai zaman kansa ya haɗa da ƙwararrun kiwon lafiya da cibiyoyin kiwon lafiya waɗanda ke kula da marasa lafiya masu samun kuɗi, masu cin gajiyar OS, da masu riƙe inshora masu zaman kansu.Wannan tsarin ƙasa kuma ya haɗa da kamfanonin inshora na son rai da ake kira kamfanonin inshora "magungunan da aka riga aka biya".Ta hanyar kuɗin inshora, daidaikun mutane, iyalai da ma'aikata suna ba da kuɗi don kamfanonin inshorar likita waɗanda aka riga aka biya.7 asibitocin jama'a na Argentine suna da kashi 51% na adadin asibitocin sa (kimanin 2,300), suna matsayi na biyar a cikin ƙasashen Latin Amurka waɗanda ke da asibitocin jama'a.Matsakaicin gadaje asibiti shine gadaje 5.0 ga mazauna 1,000, wanda ma ya fi na 4.7 a cikin ƙasashe na Ƙungiyar Haɗin Kan Tattalin Arziƙi da Ci Gaba (OECD).Bugu da kari, Argentina tana daya daga cikin mafi girman adadin likitoci a duniya, tare da 4.2 a cikin 1,000 mazaunan, wanda ya wuce OECD 3.5 da matsakaicin Jamus (4.0), Spain da Ingila (3.0) da sauran ƙasashen Turai.8
Kungiyar Lafiya ta Amurka (PAHO) ta jera Hukumar Kula da Abinci, Magunguna da Fasaha ta Kasar Argentina (ANMAT) a matsayin hukumar da ke da matakai hudu, wanda ke nufin za a iya kwatankwacinta da FDA ta Amurka.ANMAT tana da alhakin kulawa da tabbatar da inganci, aminci da ingancin magunguna, abinci da na'urorin likitanci.ANMAT tana amfani da tsarin rarrabuwar kawuna mai kama da wanda ake amfani da shi a cikin Tarayyar Turai da Kanada don kula da izini, rajista, kulawa, sa ido da abubuwan kuɗi na na'urorin kiwon lafiya a cikin ƙasa baki ɗaya.ANMAT tana amfani da rarrabuwa na tushen haɗari, wanda aka raba na'urorin likitanci zuwa nau'i huɗu dangane da haɗarin haɗari: Class I-mafi ƙarancin haɗari;Halin matsakaici na Class II;Class III-haɗari mai girma;da Class IV-haɗari mai yawa.Duk wani masana'anta na waje da ke son siyar da na'urorin likitanci a Argentina dole ne ya nada wakilin gida don gabatar da takaddun da ake buƙata don aiwatar da rajista.Ruwan jiko, famfo sirinji da famfon abinci mai gina jiki (famfon ciyarwa) azaman kayan aikin likitanci na calss IIb, dole ne a watsa zuwa Sabon MDR nan da 2024
Dangane da ƙa'idodin rajistar na'urar likitanci, masana'antun dole ne su sami ofishi na gida ko mai rarrabawa rajista tare da Ma'aikatar Lafiya ta Argentina don bin Mafi kyawun Ayyukan Masana'antu (BPM).Don na'urorin likitanci na Class III da Class IV, masana'antun dole ne su gabatar da sakamakon gwaji na asibiti don tabbatar da aminci da ingancin na'urar.ANMAT yana da kwanaki 110 na aiki don kimanta takaddun kuma ya ba da izini daidai;don na'urorin likitanci na Class I da Class II, ANMAT tana da kwanakin aiki 15 don kimantawa da amincewa.Rijistar na'urar likita tana aiki har tsawon shekaru biyar, kuma masana'anta na iya sabunta ta kwanaki 30 kafin ta ƙare.Akwai tsarin rajista mai sauƙi don gyare-gyare ga takaddun rajista na ANMAT na samfuran nau'in III da IV, kuma ana ba da amsa a cikin kwanakin aiki 15 ta hanyar bayyana yarda.Dole ne maƙerin ya samar da cikakken tarihin siyar da na'urar ta baya a wasu ƙasashe.10
Tunda Argentina wani yanki ne na Mercado Común del Sur (Mercosur) - yanki na kasuwanci wanda ya ƙunshi Argentina, Brazil, Paraguay da Uruguay-duk na'urorin likitancin da aka shigo da su ana biyan su haraji daidai da Mercosur Common External Tariff (CET).Adadin haraji ya tashi daga 0% zuwa 16%.Game da na'urorin kiwon lafiya da aka gyara daga waje, adadin haraji ya tashi daga 0% zuwa 24%.10
Cutar ta COVID-19 ta yi tasiri sosai a Argentina.12, 13, 14, 15, 16 A cikin 2020, jimillar kayayyakin ƙasar ya faɗi da kashi 9.9%, raguwa mafi girma cikin shekaru 10.Duk da haka, tattalin arzikin cikin gida a cikin 2021 har yanzu zai nuna mummunan rashin daidaituwa na macroeconomic: duk da sarrafa farashin gwamnati, hauhawar farashin kayayyaki na shekara-shekara a cikin 2020 har yanzu zai kai 36%.6 Duk da hauhawar farashin kayayyaki da koma bayan tattalin arziki, asibitocin Argentina sun kara sayan kayan aikin likita na yau da kullun da na musamman a cikin 2020. Ƙaruwar siyan kayan aikin likita na musamman a cikin 2020 daga 2019 shine: 17
A daidai wannan lokacin daga 2019 zuwa 2020, siyan kayan aikin likita na yau da kullun a asibitocin Argentina ya karu: 17
Abin sha'awa, idan aka kwatanta da 2019, za a sami karuwar nau'ikan kayan aikin likita masu tsada da yawa a Argentina a cikin 2020, musamman a cikin shekarar da aka soke ko jinkirta ayyukan tiyata da ke buƙatar waɗannan kayan aikin saboda COVID-19.Hasashen don 2023 ya nuna cewa ƙimar haɓakar haɓakar shekara-shekara (CAGR) na waɗannan ƙwararrun kayan aikin likitanci za su ƙaru: 17
Argentina kasa ce mai gauraya tsarin likitanci, tare da masu ba da sabis na kiwon lafiya na jama'a da masu zaman kansu kayyade.Kasuwancin kayan aikin likitanta yana ba da kyakkyawar damar kasuwanci saboda Argentina tana buƙatar shigo da kusan duk samfuran likitanci.Duk da tsauraran matakan kuɗaɗen kuɗaɗe, hauhawar hauhawar farashi da ƙarancin saka hannun jari na ƙasashen waje, 18 babban buƙatun shigo da kayan yau da kullun da kayan aikin likitanci na musamman, jaddawalin amincewar ƙa'ida, babban horo na ilimi na ƙwararrun kiwon lafiya na Argentine, da kyakkyawar ƙarfin asibiti na ƙasar Wannan ya sa Argentina ta zama ta farko. kyakkyawar makoma ga masana'antun na'urorin likitanci waɗanda ke son faɗaɗa sawun su a Latin Amurka.
1. Organización Panamericana de la Salud.Regulación de dispositivos médicos [Internet].2021 [An nakalto daga Mayu 17, 2021].Akwai daga: 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 //COVID-19]. cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. Organización Panamericana de la salud.Dispositivos medicos [Internet].2021 [An nakalto daga Mayu 17, 2021].Akwai daga: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro.Argentina: Tattalin Arziki y demografia [Internet].2021 [An nakalto daga Mayu 17, 2021].Akwai daga: https://datosmacro.expansion.com/paises/argentina
5. Masanin kididdiga.Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet].2020. Akwai daga URL mai zuwa: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
6. Bankin Duniya.Bankin Duniya na Argentina [Internet].2021. Akwai daga gidan yanar gizon mai zuwa: 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.Akwai daga: 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.Bayanin Lafiya na Duniya [Internet].2018;Akwai daga: https://globalhealthintelligence.com/es/analisis-de-ghi/latinoamerica-es-uno-de-los-mercados-hospitalarios-mas-robustos-del-mundo/
9. Ministan Argentina Anmat.ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet].2018. Akwai daga: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. RegDesk.Bayanin ƙa'idodin na'urar likitancin Argentina [Internet].2019. Akwai daga: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Kodinetan kwamitin fasahar noma.Productos médicos: normativas sobre habilitaciones, registro da trazabilidad [Internet].2021 [An nakalto daga Mayu 18, 2021].Akwai daga: http://www.cofybcf.org.ar/noticia_anterior.php?n=1805
12. Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. Yi la'akari da shirye-shiryen bala'in asibiti ta hanyar yanke shawara mai ma'ana da yawa: Dauki asibitocin Turkiyya a matsayin misali.Int J Rage Hadarin Bala'i [Internet].Yuli 2020;101748. Akwai daga: 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, da dai sauransu Tasirin cutar ta COVID-19 akan lafiyar kwakwalwar jama'a: babban sharhin labari.Dorewa [Internet].Maris 15 2021;13 (6): 3221.Akwai daga: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
14. Clemente-Suárez VJ, Hormeno-Holgado AJ, Jiménez M, Agudelo JCB, Jiménez EN, Perez-Palencia N, da dai sauransu Haɓaka rigakafin yawan jama'a saboda tasirin rukuni a cikin cutar ta COVID-19.Alurar rigakafi [Internet].Mayu 2020;samuwa daga: https://www.mdpi.com/2076-393X/8/2/236 doi: 10.3390/vaccines8020236
15. Romo A, Ojeda-Galaviz C. Tango don COVID-19 yana buƙatar fiye da biyu: nazarin martanin farkon cutar a Argentina (Janairu 2020 zuwa Afrilu 2020).Int J Environ Res Kiwon Lafiyar Jama'a [Internet].Disamba 24, 2020;18 (1):73.Akwai daga: 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. Canje-canje a cikin iskar yanayi da tasirin tattalin arzikinsu yayin kulle-kullen COVID-19 a Argentina.Dorewa [Internet].Oktoba 19, 2020;12 (20): 8661. Akwai daga: 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 [An nakalto daga Mayu 17, 2021].Akwai daga: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
18. Otaola J, Bianchi W. An samu raguwar koma bayan tattalin arzikin Argentina a kashi na hudu;koma bayan tattalin arziki shine shekara ta uku.Reuters [Internet].2021;Akwai daga: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
Julio G. Martinez-Clark shi ne wanda ya kafa kuma Shugaba na bioaccess, kamfani mai ba da shawara ga kasuwa wanda ke aiki tare da kamfanonin na'urorin likitanci don taimaka musu gudanar da gwaje-gwajen asibiti da wuri da kuma tallata sabbin abubuwan su a Latin Amurka.Julio kuma shine mai watsa shirye-shiryen Podcast na Shugabannin Medtech na LATAM: tattaunawar mako-mako tare da shugabannin Medtech masu nasara a Latin Amurka.Shi memba ne na hukumar ba da shawara na manyan shirye-shiryen ƙetare ɓarna na Jami'ar Stetson.Ya yi digirin farko a fannin injiniyan lantarki da kuma digiri na biyu a fannin harkokin kasuwanci.