Engxoxweni yakamuva noCindy Pelou, Inhloko Yekomidi Elikhethekile Le-APACMed Secretariat Lezindaba Zokulawula, uMnu. Pak Fikriansyah ovela eMnyangweni Wezempilo wase-Indonesia (MOH) uchaze imizamo yakamuva ye-MOH ekulawuleni imishini yezokwelapha e-Indonesia futhi wanikeza iziphakamiso ezithile. ye-ecosystem yedivayisi yezokwelapha yase-Indonesia.
IMP: Phakathi nenqubo yokulebula kabusha, ikheli elidala lingashintshwa inqobo nje uma inkampani eyenza ukulebula kabusha inesitifiketi esivamile futhi ingabonisa ukuthi ukulebula kabusha (okuvame ukunamathela ngokwawo) akuthinti ukuphepha, ikhwalithi nokusebenza kodokotela. idivayisi.
UMBUZO: Imuphi umnyango woMnyango Wezempilo wase-Indonesia okwamanje obuyekeza ukubhaliswa kwamaseli nokwelashwa kofuzo?
A: Imikhiqizo yokwelapha ngamaseli nofuzo ibuyekezwa yi-Indonesian Food and Drug Administration (BPOM) kanye Nophiko Olujwayelekile Lwezidakamizwa Nezinto Zokwelapha.
Q: Ezinkampanini ezidinga ukubhalisa imikhiqizo yazo, isiphi isigaba sengozi esisebenzayo semishini yezokwelapha?Uthini umugqa wesikhathi olindelekile wokugunyazwa kokubhalisa?
A: Ukubuyekezwa kwalolu lwazi kuwumsebenzi we-FDA Indonesia (BPOM).
Umbuzo: Ingabe izinguquko ezincane zamalebula (isb. ukuguqulwa kophawu/ukushintsha kombala) zingenziwa ngesaziso?
IMP: Okwamanje, ushintsho luvunyelwe uma lusebenza kuyo yonke noma emikhiqizweni eminingi.Kodwa-ke, uma sisebenza emkhiqizweni owodwa noma emibili kuphela, kudingeka isaziso soshintsho.
UMB: Phakathi kukaMeyi no-Agasti 2021, sibe nezingxoxo noMnyango Wezempilo (MOH) mayelana nencwadi evela ku-Gakeslab equkethe iziphakamiso zokubhaliswa kwe-RUO (ukusetshenziswa kocwaningo kuphela) e-Indonesia.Esinye sezincomo bekuwukukhulula noma ukwenza lula ukubhaliswa kwe-RUO (ngaphambi kwemakethe nangemuva kwemakethe) e-Indonesia.Ukukhululwa nokwenza lula ukubhaliswa kwe-RUO kuzosiza ukukhuthaza indawo yocwaningo futhi kusekele i-Indonesia ekuguquleni insika yayo yezempilo.Njengoba siqhubeka nokweseka indawo yocwaningo e-Indonesia, singalandela uMnyango Wezempilo nge-RUO?
IMP: Umnyango Wezempilo wase-Indonesia uxoxisane nge-RUO futhi wazuza nemininingwane endleleni ephethwe ngayo yi-Health Sciences Authority (HSA) e-Singapore.Sifunde ukuthi i-HSA ayiwalawuli ama-RUO kodwa isebenzisa izilawuli eziqinile zangemuva kokumaketha.Kukhona unswinyo olunzima uma imikhiqizo ye-RUO isetshenziselwa ukwelashwa.Kodwa-ke, uma kubhekwa imakethe enkulu yase-Indonesia enenani elikhulu lamalabhorethri, ngeke sikwazi ukwamukela le modeli.I-Indonesia okwamanje isebenzela ukuqinisa umthetho futhi sivuleleke ezingxoxweni ne-APACMed nabanye ababambiqhaza ukuze sinikeze izindlela ezingcono kakhulu.
Umbuzo: Ingabe i-Indonesia iyakuvumela ukulebula ngemva kokungenisa?(isb. ngemuva kwethenda kahulumeni yokugunyazwa kwentela noma ukuguqulwa kwamalebula)
A: Ukulebula kabusha kuvunyelwe ngemva kokunikezwa isitifiketi nokuqinisekiswa ukuthi awukho umthelela kwikhwalithi nokuphepha komkhiqizo.
Umbuzo: Yiziphi izingozi zokungenisa impahla enamalebula axubile?Isibonelo, ilebula yebhokisi inegama lenkampani elisha kodwa ngaphakathi, i-IFU (imiyalelo yokusetshenziswa kwemishini yezokwelapha) isaqukethe igama lenkampani elidala.Ingabe uMnyango Wezempilo wase-Indonesia uyasivumela isikhathi soshintsho ukuze uguquko lwamalebula/IFU lungathathwa njengemfuneko yokuyeka ngempoqo?
IMP: Uma kunomehluko phakathi kwe-IFU nokulebula, cishe izonqatshwa njengoba kubalulekile ukugcina ukuvumelana.Nakuba ezinye izikhathi zomusa zecala ngalinye zinikezwa, izikhalazo nokucatshangwa komthelela emphakathini kusadingeka.Ngakho-ke kunconywa kakhulu ukuqinisekisa ukuthi yonke imikhiqizo enelebula emidala ingenisiwe ngaphambi kokuthumela isibuyekezo ukuze kuvinjelwe ukuphinda kungeniswe futhi kuqinisekiswe ukushintshwa okushelelayo.Kuye ngesimo, ungase ukwazi ukulebula kabusha umkhiqizo usebenzisa ukugunyazwa okulungile.
Q: I-APACMed iphromotha uhlelo lokuthembana olulawulayo, uthini umbono woMnyango Wezempilo wase-Indonesia ngalolu hlelo?Njengoba inqubomgomo yamanje kuwukukhiqiza imikhiqizo yasendaweni eyengeziwe, i-Indonesia ingazuza kumodeli yokwethenjwa futhi ivumele ukunwetshwa komkhiqizo kwezinye izimakethe ezibalulekile ze-ASEAN.
IMP: Umnyango Wezempilo wase-Indonesia unentshisekelo enkulu ekulawuleni imodeli yokwethenjwa futhi ungathanda ukubambisana ne-Health Sciences Authority (HSA) yase-Singapore kanye Negunya Lempahla Yezokwelapha (TGA) yase-Australia.Lolu hlelo lusaqala, nakuba kulindeleke ukuthi luqale ukusebenza ngonyaka ozayo.Sengiphetha, i-Indonesia iyakuthokozela ukufunda nokubamba iqhaza kumodeli yokuthembana futhi ibheke ngabomvu ukusebenzisana ne-APACMed kule phrojekthi.
UMB: Mayelana nemithetho ye-Halal (Umthetho we-Halal), imikhiqizo eyenziwe ngezinto ezingezona eze-halal idinga ukubonisa ulwazi olufanele ngelebula ngaphambi kokuba ingeniswe futhi isatshalaliswe e-Indonesia.Ingabe ikhona imihlahlandlela yokunquma ukuthi imikhiqizo yethu i-halal noma ayiyona i-halal?
A: Izingxoxo zokukhishwa kwemihlahlandlela yokulebula ngo-2024 ziyaqhubeka.Sisasebenzela ukuthuthukisa imihlahlandlela ecacile, sizama ukungenzi inkimbi inqubo yasekuqaleni.UMnyango Wezempilo wase-Indonesia uyazamukela iziphakamiso zendlela engcono kakhulu yokuthuthukisa imihlahlandlela.
Umbuzo: Luthini uhlelo lukahulumeni uma umkhiqizo/umkhiqizo okhiqizwa endaweni ufinyelela kumaphesenti adingekayo wokuqukethwe kwendawo?(Kushiwo ngenhla ukuthi lo mkhiqizo uzoqandiswa kukhathalogi ye-e, yisiphi isinyathelo esilandelayo?)
IMP: Imikhiqizo kuphela enezicaciso ezihlukile kulezo ezikhiqizwe endaweni ezovunyelwa ukungena emakethe yangasese.Le nqubomgomo izoqhubeka kuze kube unyaka ozayo futhi ingase ishintshe ngemva kokhetho lwango-2024.Sizoqhubeka nokuqapha amathuba omkhakha wemishini yezokwelapha.
UMB: Ngingathanda ukwazi ukuthi izibhedlela ezizimele zizosebenzisa yini Uhlelo Lokukhuthaza Ukusetshenziswa Okungeziwe Kwemikhiqizo Yasendaweni (P3DN)?Uma kunjalo, uthini umugqa wesikhathi olindelekile?Ingabe lokhu kusho ukuthi izibhedlela ezizimele zizokwazi ukuthenga imikhiqizo yendawo kuphela?
IMP: Alukho uhlelo oluqondile lwemakethe ezimele nezibhedlela ngalesi sikhathi.Ngakho-ke, ukhululekile ukubamba iqhaza ekuhwebeni nasekuthengeni ezimakethe ezizimele.Ukusebenzisa izimakethe ezizimele ukuhweba nokuthenga.
Umbuzo: I-Indonesia iyiphatha kanjani imishini yezokwelapha elungiswe kabusha?
IMP: Sihlanganisa umthetho woMnyango Wezohwebo kanye Nomnyango Wezimboni ovimbela izimpahla ezivuselelwe ukuthi zingene emakethe yase-Indonesia.Lo mthetho wasetshenziswa ukuphendula izinselelo i-Indonesia ebhekane nazo esikhathini esedlule lapho kungena izimpahla ezilungisiwe kuphela emakethe.Inhloso yale mithetho ukuvimbela ukuthutheleka kwezimpahla ezivuselelwe ngobuningi.Sizobeka phambili ukutholakala komkhiqizo futhi sihlale siqinisekisa ikhwalithi engaguquki.
UMB: Okwamanje iqembu lokuhlukanisa loMnyango Wezempilo wase-Indonesia lisekelwe ekucacisweni kwedivayisi, okufana nomumo ohlukile (i-catheter yesokunxele, i-catheter yesokudla), engadinga ukubhaliswa kwamalayisensi amaningi.Ingabe uMnyango Wezempilo unazo izinhlelo zokulungisa iqembu ngokusekelwe ku-ASEAN Medical Device Directive (AMDD)?
IMP: Ungabuka idokhumenti yomhlahlandlela ekuqoqweni kuwebhusayithi yase-Indonesia.Imishini yezokwelapha ingahlukaniswa ngezigaba ezahlukahlukene njengomndeni, uhlelo kanye neqembu.Ayikho imali eyengeziwe yokubhalisa ngeqembu noma ngomkhiqizo ngamunye.
Q: Ingabe ikhona inhloso yokusebenzisa iqembu elifanayo lemikhiqizo yokuxilonga ye-in vitro (IVD)?
A: Imikhiqizo ye-IVD ihlukaniswe yaba amasistimu avaliwe navulekile.Kunemininingwane eyengeziwe etholakala emqulwini weziqondiso otholakala kuwebhusayithi yoMnyango Wezempilo wase-Indonesia.Ukufakwa ngezigaba kwemikhiqizo ye-IVD kulandela iphethini efanayo naleyo ye-AMDD.Izingxoxo zisasaqhubeka mayelana nendlela yokuqondanisa ukuqoqwa nohlelo lwe-e-catalog.
Q: Ingabe imikhiqizo engeyona i-halal ibhekisela emikhiqizweni equkethe izinto zemvelaphi yezilwane kodwa engagunyaziwe, noma ingabe ibhekisela emikhiqizweni engaqukethe izinto zemvelaphi yezilwane?
IMP: Imikhiqizo engeyona eyesilwane ayidingi isitifiketi se-Halal.Imikhiqizo equkethe imvelaphi yezilwane kuphela edingekayo.Uma umkhiqizo ungathobeli uhlelo lwesitifiketi se-Halal, ukulebula okufanele kuyadingeka.
Q: Ingabe kuzoba nemihlahlandlela ehlukene yemikhiqizo ye-IVD ngokwemithetho ye-halal?
A: Imihlahlandlela yamanje isebenza kuphela emikhiqizweni yensiza yezokwelapha ethathwe ezilwaneni.Kodwa-ke, uma kucatshangelwa ukuthi ama-IVD athintana ngqo nomzimba wesiguli, kungenzeka ukuthi kusungulwe iziqondiso ezihlukene zazo.Kodwa-ke, akukaze kube nengxoxo ngemihlahlandlela ye-IVD ngalesi sikhathi.
Q: Kwenzekani uma umkhiqizo wokudla we-Class D umdala kunesikhathi esithathayo ukuthola isitifiketi se-halal kodwa uvela esilwaneni?
IMP: Lesi yisimo lapho izimfuneko zokulebula ezengeziwe zizodinga ukuhlangatshezwana nazo.Okwamanje sisezingxoxweni zokunquma uhlobo oluthile lokulebula oludingekayo.Umgomo wethu uwukuqinisekisa ukuthi imithethonqubo ifanelekile futhi ilinganiselwe ukuze kuqinisekiswe ukuphepha kwesiguli kanye nokugwema ukungaphansi noma ngokweqile.Kubalulekile ukuqaphela ukuthi lokhu akukona ukuvinjelwa kwemikhiqizo engena emakethe yase-Indonesia, kuphela ukulebula kuyadingeka ukuze ungene emakethe.
Q: Uma ushintsho lwedizayini noma ushintsho lomkhiqizo lwenzeka ngemva kokugunyazwa komkhiqizo, inkambiso yamanje ukuthumela kabusha isicelo.Kungenzeka yini ukuguqula inqubo noma ezinye izinyathelo zokugwema ukuhanjiswa kabusha?
IMP: Uma uguquko lubandakanya ukulebula nokupakishwa, inqubo yokuguqula ingenzeka.Inqubo yokuguqulwa koshintsho ivunyelwe uma ingaqinisekiswa ukuthi ushintsho ngeke luthinte ukuphepha, ikhwalithi, noma ukusebenza kahle komkhiqizo.
Isikhathi sokuthumela: Jul-28-2023