Mukubvunzurudzwa kwazvino neCindy Pelou, Musoro weDare reMuchestoriti Remunyori weDare reKutora, Mr. Pak Fekriansah Kubva kuChinyorwa Chekupedzisira. Kune iyo Indonesia yekurapa mudziyo Elosystem.
A: Munguva yeTobelment process, kero yekare inogona kutsiviwa kwenguva yakareba seyakaitwa nekambani yeTestire ine mutambi wenhamba (kazhinji anozvishambidza zvinyorwa) haakanganise kuchengetedzwa, kunaka uye kuita kwekurapa mudziyo.
Q: Ndeipi Dhipatimendi reIndonesia Ministry Yehutano Parizvino Ongororo Cell uye Gene Kurapa Registration?
A: Cell uye gengeni zvigadzirwa zvekurapa zvinoongororwa neiyo Indonesia chikafu uye drug yekutungamira (bpom) uye iyo Direurate General yezvinodhaka uye zvinyorwa zvekurapa.
Q: Kwemakambani anofanirwa kunyoresa zvigadzirwa zvavo, chii chinoshanda njodzi yekufananidzwa kwemidziyo yekurapa? Ndeipi iyo inotarisirwa nguva yenguva yekunyoresa kubvumidzwa?
A: Kuongorora kweruzivo urwu ndiro basa reFDA Indonesia (BSM).
Q: Inogona kudiki madiki ekuchinja (semuenzaniso chiratidzo chekuchinja / ruvara shanduko) ita kuti ishandiswe nekuzivisa?
A: Parizvino, shanduko inobvumidzwa kana ichiratidza kune zvese kana zvakawanda zvigadzirwa. Nekudaro, kana zvichiratidza kune chimwe chete kana zviviri zvigadzirwa, shanduko yekuchinja inodiwa.
Q: Pakati pemay uye Nyamavhuvhu 201, isu takanga tataura neushumiri hwehutano (moh) maererano netsamba kubva kuGekenari ine ruo (kushandisa chete) kunyoresa muIndonesia. Imwe yemakiridzo yaive yekuregererwa kana kurerutsa ruo kunyoresa (pre-musika uye post-musika) muIndonesia. Kureurura uye kurerutsa ruo kunyoresa kuchabatsira kusimudzira nzvimbo yekutsvagisa uye kutsigira Indonesia mukuchinja mbiru yake yehutano. Sezvo isu tichiramba tichitsigira nzvimbo yekutsvaga muIndonesia, tinogona here kutevedzera hushumiri hwehutano pane ruo?
A: Hushumiri hwaIntonesia hwehutano hwakurukura neguo uye kuwana ruzivo kubva munzira iyo inotungamirwa nehutano hwehurume sainzi masheya (HSA) muSingapore. Takadzidza kuti HSA haatauri ruwren asi vanoshandisa masisitimu akasarudzika ekushambadzira. Kune zvirango zvakanyanya kana mari yekugadzira inoshandiswa kurapwa. Nekudaro, yakapihwa iyo yakakura yeIndonesia musika ine nhamba huru yemarabhoritari, hatizokwanisa kutora iyi modhi. Indonesia parizvino iri kushanda kuti isimbise kudzora uye isu takavhurika pakukurukurirana neyekupokana uye vamwe vanochinjisa kupa maitiro akanakisa.
Q: Indonesia inobvumira kunyora mushure mekununurwa here? (semuenzaniso mushure mehurumende nyoro yetsika clearance clearance kana shanduko yekuchinja)
A: Relabeling inotenderwa mushure mekutsigirwa uye vimbiso yekuti hapana kukanganisa pane kunaka uye kuchengetedzwa kwechigadzirwa.
Q: Ndedzipi njodzi dzekupinza zvinhu zvine mavara akasanganiswa? Semuenzaniso, bhokisi rebhokisi rine zita ritsva rekambani asi mukati, iyo IFU (mirairo yekushandisa yemidziyo yekurapa) ichine zita rekare rekambani. Ko hushumiri hweYenonesia hwehutano hunobvumidza nguva yekuchinja kuti shanduko yeyazaravhani / iFU haina kutariswa zvinodiwa nekuchengetedzwa?
A: Kana paine musiyano uripo pakati peiyo IFU uye chirevo, chingangodaro chirangarirwa sezvazvakakosha kuchengetedza kusawirirana. Kunyangwe imwe nyaya-ne-kesi nguva yenyasha dzinopihwa, kukwikwidza uye kufunga nezvekukanganisa munharaunda kuchiri kudikanwa. Saka zvinokurudzirwa zvikuru kuve nechokwadi chekuti zvese zvekare zvakanyorwa kare zvakanyorwa zvakabviswa kunze kwekutumira iyo yekuvandudza kuti udzivise kuendesa zvakare uye kuve nechokwadi chekuchinja. Zvichienderana nemamiriro ezvinhu, iwe unogona zvakare kukwanisa kutora zvakare chigadzirwa uchishandisa mvumo chaiyo.
Q: Akashongedzwa ari kusimudzira chirongwa chekudzora chivimbo, ndeipi hushumiri hweIndonesia yehutano hwehutano pachirongwa ichi? Sezvo iyo yazvino mutemo ndeyekugadzira zvimwe zvigadzirwa zvemunharaunda, Indonesia inogona kubatsirwa kubva kune kuvimba kwemhando uye kubvumira kuwedzera kwechigadzirwa mune mamwe misika yeASEAS.
A: Hushumiri hweIndonesia hwehutano hunofarira kwazvo kudzora muenzaniso wekuvimbika uye vangada kubatana nehutano hwehunyanzvi masimba (HSA) Singapore uye Chekurapa Chemauto (TGA) yeAustralia. Iko kuita kwacho kuchiri mumucheche wayo, kunyangwe kushandisirwa kunotarisirwa gore rinouya. Mukupedzisa, Indonesia inofadza kudzidza uye kutora chikamu mumuenzaniso wokuvimba uye anotarisira kushanda pamwe nekune projekiti iyi.
Q: Pamusoro peHalal mitemo (Halal mutemo), zvigadzirwa zvakagadzirwa kubva kune zvisiri-halal zvinhu zvinoda kuratidza ruzivo rwakakodzera pane chinyorwa chisati chaendeswa kuIntonesia. Pane nhungamiro yekuona here kuti zvigadzirwa zvedu zviri Halal kana zvisiri-halal?
A: Kukurukurirana pane kupa zvinyorwa zvekushandisa na2024 vari kuenderera mberi. Isu tichiri kushanda pakukura nhungamiro dzakajeka, tichiedza kusaomesa maitiro ekutanga. Hushumiri hweIndonesia hwehutano hunotambira mazano munzira yakanaka yekukudziridza nhungamiro.
Q: Ndeipi hurongwa hwehurumende apo mucherechedzo wechigadzirwa (Yakataurwa pamusoro pekuti ichi chigadzirwa chichava chando mune e-catalog, chii chinhanho chinotevera?)
A: Zvigadzirwa chete neakasiyana zvakatemwa kubva kune izvo zvinogadzirwa munharaunda zvichabvumidzwa kupinda mumusika wega wega. Iyi purogiramu ichaenderera kusvika gore rinouya uye rinogona kuchinja mushure mesarudzo 2024. Isu ticharamba tichiongorora tarisiro yeiyo yekuzvirapa yekuchengetedza chikamu.
Q: Ini ndoda kuziva kana zvipatara zvakazvimiririra zvichaita chirongwa ichi kukurudzira kushandiswa kwezvigadzirwa zvemuno (P3DN)? Kana zvirizvo, chii chinotarisirwa nguva yakatarwa? Izvi zvinoreva here kuti zvipatara zvakazvimiririra zvinongogona kutenga zvigadzirwa zvemuno?
A: Iko hakuna chirongwa chakananga kumusika wepamhepo uye zvipatara panguva ino. Naizvozvo, wakasununguka kutora chikamu mumusika wepamhepo yekutengesa uye kutenga. Kushandisa misika yakazvimiririra yekutengesa nekutenga.
Q: Indonesia inobata sei dzakasvibiswa zvekurapa zvekurapa?
A: Isu tinobatanidza mutemo wehushumiro rekutengeserana uye hushumiri hweindasitiri izvo zvinorambidza zvinhu zvakazotambudza kubva mukupinda mumusika weIndonesia. Iyi mutemo yakaitwa mukupindura kumatambudziko eIndonesia yakatarisana munguva yakapfuura kana zvinhu zvakadzama chete zvakapinda mumusika. Chinangwa chemitemo iyi ndechekudzivirira iyo kuwanda kwezvinhu zvakagadziridzwa zvakagadzirwazve muhuwandu hukuru. Isu tichagadzirisa kuwanikwa kwechigadzirwa uye kugara nechokwadi chekuenderana.
Q: Parizvino Ministary Ministry yeboka rehutano hwehutano hwakavakirwa pane zvekushandiswa zvisina mwero, dzakadai semhando dzakasiyana (dzakasiyiwa Catheter, Catheter), izvo zvaizoda kunyoreswa kwemazita mazhinji. Ko hushumiri hwehutano vane chero hurongwa hwekugadzirisa boka maererano neAsean Medical mudziyo (Amdd)?
A: Iwe unogona kutarisa gwaro ratidziro pane boka pane webhusaiti yeIndonesia. Zvishandiso zvekurapa zvinogona kuve zvakakamurwa muzvikamu zvakasiyana zvakadai semhuri, hurongwa neboka. Iko hakuna imwe yekuwedzera kubhadharwa kwekunyoresa neboka kana chimwe chigadzirwa.
Q: Pane chinangwa chekushandisa iwo mamwe mapoka muVitro Diagnostic zvigadzirwa (IVD)?
A: IVD zvigadzirwa zvakakamurwa muzvikamu zvakavharwa uye zvakavhurika. Kune zvimwe zvinhu zvinowanikwa mugwaro rokutungamira riripo muIndonesia Ministry Yezvehutano Webhusaiti.Hariyamu zvigadzirwa zveIVD zvinotevera maitiro akafanana neaMadd. Kukurukurirana kuchiri kuramba kuchiramba kuenderana nekwavo kuenderana neye e-catalog system.
Q: Ita zvigadzirwa zvisina-Halal zvinoreva zvigadzirwa zvine zvigadzirwa zvemhuka
A: Zvigadzirwa zveisiri-manhukwana manhuwa hazvidi Halal chitupa. Zvigadzirwa chete zvine mabviro emhuka zvinodikanwa. Kana chigadzirwa chisingateerere neHalal Certification system, kunyora kwakakodzera kunodiwa.
Q: Kuchave nekukasana nhungamiro yeIVD zvigadzirwa maererano neHalal mirau?
A: Nhungamiro yazvino inoshanda chete kune zvigadzirwa zvekurapa zvinobva mumhuka. Nekudaro, uchifunga kuti IVDS yakauya mukuwonana zvakananga nemuviri wemurwere, zvinogoneka kuti nhungamiro dzakaparadzaniswa dzichavandudzwa kwavari. Nekudaro, hapana kusataurirana paIVD nhungamiro panguva ino.
Q: Chii chinoitika kana kirasi d chikafu chigadzirwa chakakura kupfuura iyo nguva yainotora kuti uwane certification yeHalal asi inobva mumhuka?
A: Aya mamiriro ezvinhu apo zvimwe zvinodiwa zvekushandisa zvaizoda kuti uonzwisiswe. Isu parizvino tiri mukukurukurirana kuti tisarudze mhando yerudzi rwechokwadi rwunodiwa. Chinangwa chedu ndechekuti uve nechokwadi chekuti mitemo yakakodzera uye yakaenzana kuti ive nechokwadi chekuchengetedza moyo murefu uye kudzivirira pasi- kana kupfuura- mutemo. Izvo zvakakosha kuti ukure kuti uku hakusi kurambidzwa pazvinhu zvinopinda mumusika weIndonesia, chete izvo zvekunyora zvinodiwa kuti upinde mumusika.
Q: Kana dhizaini yekuchinja kana shanduko yechigadzirwa ichiitika mushure mekubvumidzwa kwechigadzirwa, tsika iripo ndeyekutumira chikumbiro. Zvinoita here kuti ugadzirise maitiro kana mamwe matanho ekudzivirira kutangazve?
A: Kana shanduko ikabatanidza kunyora uye kurongedza, shanduko yekuchinja shanduko inogoneka. Shanduko yekushandura maitiro inobvumidzwa kana inogona kuve nechokwadi kuti shanduko haizokanganisa kuchengetedzwa, mhando, kana kushanda kwechigadzirwa.
Kutumira Nguva: Jul-28-2023