Mubvunzurudzo ichangoburwa naCindy Pelou, Musoro weAPACMed Secretariat's Specialized Committee on Regulatory Affairs, VaPak Fikriansyah vanobva kuIndonesia Ministry of Health (MOH) vakatsanangura zvakaitwa neMOH munguva pfupi yapfuura mukugadzirisa mishonga yezvokurapa muIndonesia uye vakapa mamwe mazano. yeIndonesian medical device ecosystem.
A: Panguva yekunyorazve, kero yekare inogona kutsiviwa chero kambani iri kuita relabeling iine chitupa chakajairwa uye inogona kuratidza kuti kunyora patsva (kazhinji kuzvinamira mavara) hakukanganise kuchengetedzwa, kunaka uye kushanda kwechiremba. mudziyo.
Mubvunzo: Nderipi dhipatimendi reIndonesia Ministry of Health parizvino rinoongorora kunyoreswa kwesero uye gene therapy?
A: Cell and gene therapy products zvinoongororwa neIndonesian Food and Drug Administration (BPOM) uye Directorate General of Drugs and Medical Materials.
Mubvunzo: Kune makambani anoda kunyoresa zvigadzirwa zvawo, ndeipi inoiswa njodzi yezvishandiso zvekurapa?Ndeipi nguva inotarisirwa yekubvumidza kunyoresa?
A: Ongororo yeruzivo urwu ibasa reFDA Indonesia (BPOM).
Mubvunzo: Ko shanduko diki dzemazita (semuenzaniso shanduko yechiratidzo / shanduko yeruvara) inogona kuitwa nekuzivisa?
A: Parizvino, shanduko inotenderwa kana ichishanda kune zvese kana zvakawanda zvigadzirwa.Nekudaro, kana ichishanda kune chimwe chete kana zviviri zvigadzirwa, shanduko yekuzivisa inodiwa.
Mubvunzo: Pakati paMay naNyamavhuvhu 2021, takaita hurukuro neBazi Rehutano (MOH) maererano netsamba kubva kuGakeslab ine zvikumbiro zveRUO (tsvakurudzo inoshandiswa chete) kunyoresa muIndonesia.Imwe yekurudziro yaive yekuregedza kana kurerutsa RUO kunyoreswa (pre-market uye post-market) muIndonesia.Kuregera uye kurerutsa RUO kunyoreswa kuchabatsira kusimudzira nharaunda yekutsvagisa uye kutsigira Indonesia mukushandura mbiru yehutano.Sezvo isu tichiramba tichitsigira nzvimbo yekutsvagisa muIndonesia, isu tinogona here kutevera neBazi rezvehutano paRUO?
A: Ministry of Health yeIndonesia yakakurukura nezveRUO uye yakawana ruzivo kubva munzira iyo inotungamirirwa neHealth Sciences Authority (HSA) muSingapore.Takadzidza kuti HSA haidzoreri maRUOs asi inoshandisa yakasimba post-marketing controling.Kune zvirango zvakakomba kana zvigadzirwa zveRUO zvichishandiswa kurapwa.Nekudaro, tichipihwa musika wakakura weIndonesia une nhamba huru yemarabhoritari, isu hatigone kutora iyi modhi.Indonezhiya parizvino iri kushanda kuti isimbise mutemo uye isu takavhurika nhaurirano neAPACMed nevamwe vane chekuita kuti vape maitiro akanaka.
Mubvunzo: Indonezhiya inobvumira kuisa mazita mushure mekutengesa kunze kwenyika?(semuenzaniso mushure mekupa mvumo yehurumende yemvumo yetsika kana shanduko yemavara)
A: Relabeling inobvumidzwa mushure mekupihwa chitupa uye vimbiso yekuti hapana kukanganisa pamhando uye kuchengetedzeka kwechigadzirwa.
Mubvunzo: Ndedzipi njodzi dzekuunza kunze zvinhu zvine mavara akasanganiswa?Semuenzaniso, bhokisi rebhokisi rine zita idzva rekambani asi mukati, IFU (mirayiridzo yekushandiswa kwemishonga yezvokurapa) ichine zita rekare rekambani.Iyo Indonesia Ministry of Health inobvumira here nguva yekuchinja kuitira kuti shanduko yekunyora / IFU isatariswe sekumanikidzwa kurega kudiwa?
A: Kana paine mutsauko pakati peIFU nemazita, zvingangorambwa nekuti zvakakosha kuchengetedza kuenderana.Kunyange zvazvo dzimwe nguva dzenyasha dzechiitiko-ne-nyaya dzichipihwa, zvikumbiro uye kufunga nezvekukanganisa munharaunda kuchiri kudikanwa.Saka zvinokurudzirwa zvikuru kuona kuti zvigadzirwa zvekare zvekare zvaunzwa kunze kwenyika usati waendesa imwe update kudzivirira kupinza zvakare kunze kwenyika uye kuona shanduko yakanaka.Zvichienderana nemamiriro ezvinhu, unogona zvakare kunyora zvakare chigadzirwa uchishandisa mvumo chaiyo.
Mubvunzo: APACMed iri kusimudzira chirongwa chekuvimba, chii chinonzi Indonesia Ministry of Health maonero pachirongwa ichi?Sezvo mutemo wazvino uri kugadzira zvigadzirwa zvemuno, Indonesia inogona kubatsirwa kubva kune yekuvimba modhi uye kubvumidza kuwedzera chigadzirwa mune mamwe makiyi misika yeASEAN.
A: Bazi rezvehutano reIndonesia rinofarira zvikuru kudzora mhando yekuvimba uye rinoda kushanda pamwe neHealth Sciences Authority (HSA) yekuSingapore neMedical Supplies Authority (TGA) yekuAustralia.Chirongwa ichi chichiri kutanga, kunyange hazvo chiri kutarisirwa kuitwa gore rinouya.Mukupedzisa, Indonesia inofara kudzidza uye kutora chikamu mumuenzaniso wekuvimba uye inotarisira kushanda neAPACMed pachirongwa ichi.
Mubvunzo: NezveHalal mirau (Halal Law), zvigadzirwa zvakaitwa kubva kune zvisiri-halal zvinhu zvinoda kuratidza ruzivo rwakakodzera pane iyo label isati yaunzwa kunze uye kugoverwa kuIndonesia.Pane here nhungamiro yekuona kana zvigadzirwa zvedu zviri halal kana zvisiri-halal?
A: Hurukuro dzekupa magwaro ekunyora panosvika 2024 dziri kuenderera mberi.Tichiri kushanda pakugadzira nhungamiro dzakajeka, tichiedza kusaomesa maitiro ekutanga.Bazi rezvehutano reIndonesia rinogamuchira mazano enzira yakanakisa yekugadzira nhungamiro.
Mubvunzo: Hurongwa hwehurumende ndehupi kana chigadzirwa/chigadzirwa chinogadzirwa munharaunda chasvika pachikamu chinodiwa chezvemukati menyika?(Zvakataurwa pamusoro apa kuti chigadzirwa ichi chichave nechando mu-e-catalog, ndeipi nhanho inotevera?)
A: Zvigadzirwa chete zvine zvirevo zvakasiyana kubva kune izvo zvinogadzirwa muno ndizvo zvinotenderwa kupinda mumusika wega.Gwaro iri richaenderera mberi kusvika gore rinouya uye rinogona kuchinja mushure mesarudzo dza2024.Tichaenderera mberi nekutarisa tarisiro yechikamu chemidziyo yekurapa.
Mubvunzo: Ndinoda kuziva kana zvipatara zvepachivande zvichizoshandisa Chirongwa cheKukurudzira Kuwedzera Kushandiswa Kwezvigadzirwa Zvemunharaunda (P3DN)?Kana zvakadaro, ndeipi nguva inotarisirwa?Izvi zvinoreva here kuti zvipatara zvakazvimiririra zvinongokwanisa kutenga zvigadzirwa zvemuno chete?
A: Hapana chirongwa chakananga chemusika wakazvimirira uye zvipatara panguva ino.Naizvozvo, wakasununguka kutora chikamu mune yakavanzika musika kutengesa uye kutenga.Kushandisa misika yakazvimirira yekutengesa nekutenga.
Mubvunzo: Indonesia inobata sei midziyo yekurapa yakagadziridzwa?
A: Isu tinobatanidza mutemo weBazi Rekutengeserana uye Bazi reIndasitiri inorambidza zvinhu zvakagadziridzwa kupinda mumusika weIndonesia.Mutemo uyu wakaitwa mukupindura matambudziko akasangana neIndonesia munguva yakapfuura apo zvinhu zvakagadziridzwa chete zvakapinda mumusika.Chinangwa chemitemo iyi ndechekudzivirira kupinda kwezvinhu zvakagadziridzwa zvakawanda.Tichakoshesa kuwanikwa kwechigadzirwa uye tinogara tive nechokwadi chekuenderana.
Mubvunzo: Parizvino Bato reIndonesia reHutano rekuisa mapoka rakavakirwa pane zvakatemwa zvemidziyo, senge maumbirwo akasiyana (catheter yekuruboshwe, catheter yekurudyi), izvo zvinoda kunyoreswa kwemarezinesi akawanda.Ministry of Health ine here hurongwa hwekugadzirisa boka iri paASEAN Medical Device Directive (AMDD)?
A: Unogona kuona gwaro rekutungamira pakuisa mapoka pawebhusaiti yeIndonesia.Zvishandiso zvekurapa zvinogona kuiswa muzvikamu zvakasiyana semhuri, system uye boka.Hapana imwe mari yekubhadhara yekunyoresa neboka kana chigadzirwa chega.
Mubvunzo: Pane chinangwa chekushandisa boka rimwechete re in vitro diagnostic products (IVD)?
A: Zvigadzirwa zveIVD zvakaiswa muzvikamu zvakavharwa uye zvakavhurika masisitimu.Pane zvimwe zvakawanda zvinowanikwa mugwaro rekutungamira rinowanikwa pawebhusaiti yebazi rezvehutano reIndonesia.Kuiswa kwezvikamu zveIVD kunotevera patani yakafanana neye AMDD.Nhaurirano dzichiri kuenderera mberi pamusoro pekuti ungabatanidza sei boka racho ne-e-catalog system.
Mubvunzo: Ko zvigadzirwa zvisiri-halal zvinoreva zvigadzirwa zvine zvinhu zvemhuka zvakabva asi zvisina halal certified, kana zvinoreva zvigadzirwa zvisina chero zvinhu zvemhuka?
A: Zvigadzirwa zvisiri zvemhuka hazvidi Halal certification.Zvigadzirwa chete zvine mavambo emhuka zvinodiwa.Kana chigadzirwa chisingaenderane neHalal certification system, kunyora kwakaringana kunodiwa.
Mubvunzo: Pachave negwara rakasiyana rezvigadzirwa zveIVD maererano nemitemo ye halal?
A: Mazano azvino anongoshanda kune zvigadzirwa zvekurapa zvakatorwa kubva kumhuka.Zvisinei, tichifunga kuti maIVD anosangana zvakananga nemuviri wemurwere, zvinokwanisika kuti nhungamiro dzakasiyana dzichagadzirirwa ivo.Zvisinei, pave pasina nhaurirano pamusoro pemirayiridzo yeIVD panguva ino.
Mubvunzo: Chii chinoitika kana chigadzirwa cheKirasi D chekudya chakura kupfuura nguva yaunotora kuwana halal certification asi chichibva kumhuka?
A: Aya ndiwo mamiriro ezvinhu apo zvimwe zvinodiwa zvekunyora zvingada kuzadzikiswa.Parizvino tiri munhaurirano dzekuona kuti ndedzipi mhando yezita rezita rinodiwa.Chinangwa chedu ndechekuona kuti mirairo yakakodzera uye yakaenzana kuti ive nechokwadi chekuchengetedzwa kwemurwere uye kudzivirira pasi-kana kudarika-mutemo.Izvo zvakakosha kuti uzive kuti uku hakusi kurambidzwa kwezvigadzirwa zvinopinda mumusika weIndonesia, chete kuti kunyora kunodiwa kuti upinde mumusika.
Mubvunzo: Kana shanduko yedhizaini kana shanduko yechigadzirwa ikaitika mushure mekubvumidzwa kwechigadzirwa, tsika iripo ndeyekutumirazve application.Zvinoita here kugadzirisa maitiro kana mamwe matanho ekudzivirira kutumirwazve?
A: Kana shanduko ichisanganisira kunyora uye kurongedza, shanduko yekuchinja maitiro inogoneka.Shanduko yekuchinja nzira inotenderwa kana ichigona kuve nechokwadi kuti shanduko haizokanganisa kuchengetedzeka, kunaka, kana kushanda kwechigadzirwa.
Nguva yekutumira: Jul-28-2023