1, Yintoni iNdlela eYodwa yokuchongwa kwezixhobo zonyango?
Ukuchongwa okukodwa kwezixhobo zonyango kubandakanya ukuchongwa kweMveliso kunye nokuchongwa kweMveliso.Ukuchongwa kweMveliso yiKhowudi ekhethekileyo yokuchonga uMbhalisi / iFayile, iModeli, iNkcazo kunye nePackage yeZixhobo zoNyango.Ligama elithi "Igama elingundoqo" lokufumana ulwazi olululo lwezixhobo zonyango kwiDatha yeDatha, kwaye yiNgxelo eyimfuneko yeSichongi esiKhethekileyo.Ukuchongwa kweMveliso kubandakanya iNgcaciso eNxulumene neNkqubo yeMveliso, kubandakanywa inombolo yeBatch yeMveliso, iNombolo yeSiriyali kunye noMhla woMveliso weXesha kunye noMhla wokuPhepha, njl njl., Inokusetyenziswa ngokudityaniswa nokuchongwa kweMveliso ukuze kuhlangatyezwane nezidingo zokuchongwa okuFanelekileyo kunye nokuRekhoda kwi-circulation kunye Ukusetyenziswa kwezixhobo zonyango.
Umgaqo-siseko Wobunye, Uzinzo kunye Nokuqina.Umahluko nguMgaqo wokuQala, iSiseko sokuqinisekisa ukuchongwa okuchanekileyo kweeMveliso, kunye noMgaqo-siseko onguNdoqo woMsebenzi wokuchongwa okukodwa.Ngenxa yokuntsonkotha kweZixhobo zoNyango, Ukwahluka kuya kuhambelana neeMfuno zokuchongwa kweMveliso.Kwizixhobo zezoNyango ezineempawu ezifanayo, ukungafani kuya kukhomba kwiNkcazo enye kunye neMveliso yeMveliso;KwiiMveliso eziLawulwa nguMveliso weBatch, ukungafani kuya kukhomba kwiBatch efanayo yeeMveliso;KwiZixhobo zezoNyango eziLawulwa nguMveliso weNombolo yoSeyiri, Ukwahluka kuya kuKhomba kwiMveliso enye.
Ukuzinza kuthetha ukuba emva kokuba ukuchongwa okukodwa kunikezelwe kwiMveliso yeSixhobo sezoNyango, ngokude nje ukuba iimpawu zayo ezisisiseko azizange zitshintshe, ukuchongwa kweMveliso kufuneka kuhlale kungatshintshi.Xa ukuthengiswa kunye nokuSetyenziswa kweZixhobo zoNyango zimisiwe, ukuchongwa kweMveliso akusayi kusetyenziselwa ezinye izixhobo zonyango;Xa uThengiso kunye nokuSetyenziswa kuphinda kuqaliswe, ukuchongwa kweMveliso yokuqala kungasetyenziswa.
Ukwandiswa Kubhekiselele Kuko Ukuchongwa okuKhethekileyo kufuneka kuhambelane neeMfuno eziLawulayo kunye noPhuhliso oluqhubekayo lwezicelo eziSebenzayo.Igama elithi "Eyahlukileyo" ayithethi ukuba iNombolo yoLawulo lweNombolo yeMveliso enye yenziwe.Kwisichongiso esiKhethekileyo, ukuchongwa kweMveliso kungasetyenziswa ngokudityaniswa nokuchongwa kweMveliso ukuze kuphunyezwe ukungafani kwamaNqanaba amathathu: Ukuchazwa, iModeli, iBatch kunye neMveliso enye, ukuze kuhlangatyezwane neemfuno zangoku kunye nezexesha elizayo kwiZixhobo zoNyango Chonga iiMfuno.
2, Kutheni Ukwakha iNkqubo yokuChonga eyohlukileyo yeZixhobo zoNyango?
Itekhnoloji yezoNyango, iziyobisi kunye nezixhobo zoNyango ziiNtsika ezintathu zeNkqubo yeNkonzo yezoNyango.Izixhobo zoNyango zibandakanya iSandi, ukukhanya, uMbane, iMagnetism, iMifanekiso, iMathiriyeli, oomatshini kunye nabaPhantse iKhulu loLuleko lobuNgcali.NgamaShishini oBuchwephesha aVunyiweyo kumazwe ngamazwe, aneempawu zobuGcisa obuphezulu, ubuGcisa, ubuGcisa, ukuHlanganisa ubuChwepheshe kunye noManyano, kwaye amele Amandla aBanzi woBuchwephesha obuPhezulu beLizwe.Kwiminyaka yakutshanje, kunye noPhuhliso oluKhawulezayo lweMveliso yeSixhobo sezoNyango, ubuchwephesha obutsha kunye neeMveliso zivela kuMsinga ongapheliyo, kunye neYantlukwano yeMveliso kunye nokuntsonkotha zihlala ziphucuka.Akukho khowudi okanye into enye eneekhowudi ezininzi ekujikelezeni nasekusetyenzisweni kwezixhobo zonyango, ezichaphazela kakhulu ukuchongwa okuchanekileyo kwezixhobo zonyango kwimveliso, ukujikeleza kunye nokusetyenziswa kwezixhobo zonyango, kwaye kunzima ukufezekisa uLawulo olululo kunye noLawulo.
Isazisi seSixhobo esisodwa (UDI) Likhadi leSazisi leZixhobo zoNyango.Inkqubo yokuchonga eyodwa yeziXhobo zezoNyango iqulathe ukuchongwa okuFanayo, uMthwali weDatha kunye neDatha yeDatha.Ukunika iSixhobo ngasinye sezoNyango Ikhadi lesazisi, Ukuqaphela ukungafihli kunye nokubonwa kweMveliso, ukusebenza kunye nokuSetyenziswa, kunye nokuphucula ukulandeleka kweeMveliso ziSitshixo sokuPhulukiswa kweSixhobo soNyango soNyango kunye noPhucuko lokuSebenza ngokuFanelekileyo.Iya kudlala indima encomekayo ekuthobeleni ngokungqongqo ngoMda ongezantsi woKhuseleko lweSixhobo sezoNyango kunye noNcedo oluPhezulu loPhuhliso lweSixhobo sezoNyango.Ke ngoko, uLwakhiwo lweNkqubo yokuchonga eyodwa yeZixhobo zoNyango e-China ikwimfuno engxamisekileyo.
Ukuchongwa okukodwa kweZixhobo zezoNyango kukugqalisela kunye neNdawo eshushu kwiNdawo yoLawulo lweSixhobo soNyango lwamazwe ngamazwe.Kwi-2013, iForam ye-International Medical Device Regulatory Body (Imdrf) ikhuphe isiKhokelo seNkqubo yokuchongwa kweZixhobo zoNyango.Kwangalo nyaka mnye, iUnited States yakhupha iMimiselo kwiNkqubo yokuchonga eyodwa kwiZixhobo zoNyango, ezifuna ukuphunyezwa ngokupheleleyo kweNkqubo yokuchonga eyodwa yeZixhobo zoNyango kwisithuba seminyaka eyi-7.Kwi-2017, uMthetho we-EU wawufuna ukuphunyezwa kokuchongwa okukodwa kwezixhobo zonyango.IJapan, iOstreliya, iArgentina kunye namanye amazwe nawo aqhube umsebenzi ofanelekileyo, kwaye ukuchongwa okukodwa kweGlobal kwezixhobo zonyango kuye kwakhuthazwa ngokuqhubekayo.
Kwi-2012, iBhunga likaRhulumente likhuphe iSicwangciso seSizwe soKhuseleko lweZiyobisi kwiSicwangciso se-12 seminyaka emihlanu, esibizela "Ukusungula iKhowudi eManyeneyo yeSizwe yeZixhobo zoNyango oluPhezulu".Kwi-2016, iBhunga likaRhulumente likhuphe iSicwangciso se-13 seMinyaka emihlanu yoKhuseleko lweSizwe lweZiyobisi, olufuna "Ukwakha iNkqubo yeKhowudi yeSixhobo sezoNyango kunye nokuqulunqa iMithetho yeKhowudi yeSixhobo sezoNyango".Ngo-2019, i-Ofisi Jikelele yeBhunga likarhulumente yakhupha imisebenzi engundoqo yokuNxilisa uHlaziyo lweNkqubo yezoNyango kunye nezeMpilo ngo-2019, efuna "Ukuqulunqa iMithetho yeNkqubo yokuChonga eYodwa yeZixhobo zonyango", eSizibom kwaye yamkelwa INtlanganiso yesibhozo yeKomiti yoHlaziyo oluBanzi oluBanzi.Kwi "Isicwangciso soHlengahlengiso loNyango lwexabiso eliPhezulu lezoNyango" likhutshwe yi-Ofisi Jikelele yeBhunga leSizwe, ibeka ngokucacileyo phambili "Ukuqulunqa iNkqubo yokuchonga eyodwa yeZixhobo zoNyango" iMithetho eManyeneyo ". NgoJulayi 2019, Ukutya kukaRhulumente. Kunye noLawulo lweziyobisi, kunye neKhomishini yezeMpilo yeSizwe kunye nezeMpilo, ngokudibeneyo ikhuphe iSicwangciso soMsebenzi esiLingwayo kwiNkqubo yokuchonga eyodwa yeZixhobo zoNyango, ephawula ukuqala koLwakhiwo lweNkqubo yokuChonga eyodwa yeZixhobo zoNyango eTshayina.
3, Yintoni Ukubaluleka Kokwakha Inkqubo yokuchonga eyodwa yeZixhobo zoNyango?
Ngokusekwa kweNkqubo yokuchonga eyohlukileyo yezixhobo zonyango, iyanceda ekudityanisweni kunye nokwabelana ngedatha elawulayo, ukuPhuculwa kweModeli yoLawulo, ukuPhuculwa koLungelo oluLungileyo, ukomelezwa koLawulo loMjikelo woBomi lweZixhobo zonyango, ukucocwa kwezixhobo zonyango. IMarike, uPhuculo lweNdawo yoShishino, ukuDityaniswa koLawulo lukaRhulumente kunye noLawulo lweNtlalo, ukusekwa koBume boLawulo lweNtlalo, ukuPhakanyiswa kweNguqu yezoShishino, uPhuculo kunye noPhuhliso olusempilweni, kunye noBonelelo lwezoNyango ezingakumbi siya kwandisa iiNkonzo zonyango eziKhuselekileyo nezisebenzayo. Kwaye kwandise iMvo yoFikelelo yaBantu.
Ukusuka kwimboniselo yezoShishino, kubavelisi beZixhobo zezoNyango, ukusetyenziswa kweLogo eyohlukileyo kuluncedo ekuphuhliseni iNqanaba loLawulo loLwazi loShishino, ukuSekwa kweNkqubo yokuJonga iMveliso, ukuQinisa ukuziPhatha kweShishini, uPhucuko loLawulo lweShishini, kunye nokukhuthaza uLawulo oluPhezulu- Uphuhliso loMgangatho kuShishino lweSixhobo sezoNyango.Kumashishini oShishino lweSixhobo sezoNyango, ukuSetyenziswa kokuchongwa okukodwa kunokuseka iNkqubo yoLungiselelo lwale mihla, kwaye uqonde ukungafihli, ukubonwa kunye nobukrelekrele beSixhobo soBonelelo soNyango.KwiZiko lezoNyango, Ukusetyenziswa kokuchongwa okungafaniyo kunceda ukuNciphisa iimpazamo zeSixhobo, ukuphucula iNqanaba loLawulo lwezinto ezisetyenziswayo esibhedlele, kunye nokugcina uKhuseleko lweZigulana.
Ngokombono woLawulo lukaRhulumente, uLondolozo lweZixhobo zezoNyango, ukusetyenziswa kweSichongi esiKhethekileyo kunokwakha iDatha enkulu yoLondolozo lweZixhobo zoNyango, ukuqonda uMthombo weZixhobo zoNyango unokujongwa, indawo ekuya kuyo inokulandelelwa, uxanduva lunokubakho. Iphandwe, kwaye Iqondwe ngoLawulo oluBukrelekrele.KwiSebe loLawulo lwezeMpilo, ukuSebenzisa ukuchongwa okukodwa kunokomeleza uLawulo oluMiselweyo lweZixhobo zezoNyango, ukukhuthaza ukusekwa kweDatha enkulu yezeMpilo, ukuphucula ukusebenza kakuhle koLawulo lwezeMpilo, kunye noNcedo lweSicwangciso seMpilo saseTshayina.KwiSebe le-Inshurensi yezoNyango, inceda ekuchongeni ngokuchanekileyo izixhobo zoNyango kwiBhidi yokuThenga, ukukhuthaza ukungafihli kokuzinziswa, kunye nokulwa ubuqhophololo kunye nokuxhatshazwa.
Ngokombono woluntu, ngokubhengezwa kolwazi kunye nokwabelana ngedatha, abathengi banokusebenzisa kwaye baqonde ukusetyenziswa ngokukhululeka, kwaye bakhusele ngokufanelekileyo Amalungelo asemthethweni kunye nemidla yabathengi.
4, Yeyiphi iMigaqo yokuPhunyezwa kokuchongwa okukodwa kweZixhobo zoNyango?
Imithetho yeNkqubo yokuchonga eyodwa yeziXhobo zezoNyango (emva koku ekubhekiswa kuyo njengeMithetho) ifuna ukuba uLwakhiwo lweNkqubo yokuchonga eyodwa kufuneka ifunde ngokukhutheleyo kwiMigangatho yeHlabathi kwaye ilandele iMigaqo yeSikhokelo sikaRhulumente, ukuPhunyezwa kweShishini, ukuKhuthaza ngokubanzi kunye nokuPhunyezwa koSasazo.Ukuze kunyuswe ngcono uTshintshiselwano lwaMazwe ngaMazwe kunye noRhwebo, kwaye kwandiswe ubume boShishino, uLwakhiwo lweNkqubo yokuchonga eyodwa yaseTshayina ithatha izifundo kwiMigaqo kunye neMigangatho eyaMkelwe ngaMazwe ngaMazwe.Ukuseka iNkqubo eYodwa yokuChonga, uRhulumente udlala indima eKhokelayo, uMbhalisi / uMrekhoda NjengoMntu wokuQala onoxanduva lokuPhunyezwa, kwaye usebenzise ngokuSebenzayo ukuchongwa okukodwa ukuze kuphuculwe uMgangatho weMveliso kunye neNqanaba loLawulo lweShishini.Ngenxa yeyantlukwano kunye nokuntsonkotha kwezixhobo zonyango, ukufezekiswa kokuchongwa okukodwa kweNyathelo ngeNyathelo sisenzo esamkelweyo kwihlabathi.Izixhobo zoNyango zaseChina zilawulwa ngokweNqanaba loMngcipheko.Ngokusekwe Kumava aSebenzayo ochongo olulodwa lwaMazwe ngaMazwe, ludityaniswe neyona meko ikhoyo yoShishino lweSixhobo sezoNyango lwaseTshayina kunye noHlolo, kuqulunqwe uMgaqo-nkqubo wokuPhunyezwa kweNyathelo ngeNyathelo.Xa kuthelekiswa ne-United States kunye neYurophu, ukufezekiswa kokuchongwa okuKhethekileyo e-China kunyusile ikhonkco lokulingwa, ikakhulu ezinye izixhobo zoNyango ezikuMngcipheko oMkhulu / oNgenelelayo, kunye noFundo oluNcinane, Ukuqinisekisa iNkqubela eZinzileyo yeMithetho.
5, Ukuqonda njani ukudityaniswa kunye noKwabiwa kweDatha yeSazisi eyodwa?
Ukuqokelelwa kweeNkcukacha kunye noKwabiwa kokuchongwa kweZixhobo zoNyango eziZodwa ziphunyezwa ngokuchongwa kweDatha eYodwa yeZixhobo zezoNyango, eziQuquzelelweyo kwaye zakhiwe nguRhulumente woLawulo lweZiyobisi.UMbhalisi / Umshicileli ulayisha ukuchongwa kweMveliso kunye neeNkcukacha eziNxulumeneyo zokuchongwa okuKhethekileyo kuVimba weDatha ngokweMigangatho eFanelekileyo kunye neeNkcazo, kwaye unoxanduva lokuchaneka kunye nokungafani kweDatha.Amashishini oShishino lweSixhobo sezoNyango, amaZiko oNyango, amaSebe kaRhulumente aBalulekileyo kunye noLuntu lunokwabelana ngeDatha yeSazisi eYodwa ngoMbuzo weDatha, ukuKhuphela, ukuFakwa kweDatha kunye nezinye iindlela.
6, Ngaba IiMveliso ezidweliswe phambi kokuphunyezwa kweMithetho kufuneka zinikwe isazisi esahlukileyo?
Ukususela kuMhla wokuPhunyezwa kweMithetho, uMbhalisi / uMfaki-fayile uya kuthumela ukuchongwa kweMveliso yakhe kwiRegistration / Filing Management System xa ufaka isicelo soBhaliso, uBhaliso loTshintsho okanye ukuFayilwa kweZixhobo zoNyango ezifanelekileyo.IiMveliso zesiXhobo sezoNyango eziBalulekileyo ziya kunikwa ukuchongwa okungafaniyo ngexesha leNkqubo yeMveliso, kwaye ukuLayishwa kokuchongwa kweMveliso eYodwa yokuchongwa kunye neDatha eFanelekileyo yesiXhobo soNyango iya kugqitywa phambi kokuba iMveliso ibekwe kwiMarike.
Izixhobo zonyango eziye zaveliswa kwaye zithengisiwe phambi koMhla wokuPhunyezwa kweMithetho zisenokungabi naluphawu olulodwa lwezixhobo zonyango.
I-7, Ungayikhetha Njani i-Unique Identification Data Carrier ye-Medical Devices?
Okwangoku, abaSebenzi beDatha abaQhelekileyo kwiMarike baquka iKhowudi eneDimensional One, iKhowudi eneDimensional ezimbini kunye neRadio Frequency Tag (RFID).
IKhowudi yeDimensional enye Luphawu lweKhowudi yeBar eMele kuphela ulwazi kumkhombandlela omnye.Isetyenziswe iminyaka emininzi kwaye ineendleko eziphantsi.Inokuhambelana kakuhle neKhowudi ekhoyo yokuSkena isixhobo kwiMarike, kodwa iKhowudi yeNdlela enye ithatha indawo enkulu kwaye inekhono elibi loLungiso lomonakalo.
Ikhowudi yeDimensional ezimbini luphawu lweKhowudi yeBar emele ulwazi kumkhombandlela omacala mabini.Xa kuthelekiswa neKhowudi ye-One-Dimensional, iNdawo efanayo inokufaka iDatha eyongezelelweyo, enokuthi idlale indima entle xa ubungakanani bokupakishwa kwesixhobo bulinganiselwe.Inamandla athile okulungisa impazamo, kodwa iiMfuneko zeZixhobo zokuFunda ziPhakamileyo kuneKhowudi eneDimensional enye.
Ithegi yeRFID inoMsebenzi woGcino loLwazi, enokuFumana iSiginali yeModulation ye-Electromagnetic yoMfundi kwaye ibuyele kuMphathi weDatha weSiginali ehambelanayo.Xa kuthelekiswa neKhowudi eneDimensional enye kunye neKhowudi eneDimensional, Iindleko zoMthwali kunye neZixhobo zokuFunda ze-RFID tag ziphezulu, kodwa isantya sokufunda se-RFID siyakhawuleza, inokufikelela kwiBatch Reading, kwaye inokudlala indima kwamanye amakhonkco kunye nemimandla.
UMbhalisi / uMrekhoda unokukhetha uMthwali weDatha oLungileyo oFanelekileyo weSixhobo sezoNyango ngokweNgcaciso, iXabiso, iimeko zeSicelo esiPhambili kunye nezinye izinto zeMveliso.
UMbhalisi / uMrekhoda unokukhetha uMthwali weDatha oLungileyo oFanelekileyo weSixhobo sezoNyango ngokweNgcaciso, iXabiso, iimeko zeSicelo esiPhambili kunye nezinye izinto zeMveliso.
8, Loluphi uhlobo lwesiqinisekiso olufunwa yi-Arhente yokukhupha iKhowudi, kwaye luthini uxanduva lwalo kunye nezibophelelo?
IKhowudi ekhupha iZiko lokuchongwa kwesixhobo liya kuba liZiko elisemthethweni ngaphakathi kwiNdawo yaseTshayina, eneNkqubo yoLawulo eQhelekileyo kunye neNkqubo yokuSebenza, ukuze kuqinisekiswe ukuKhethekiswa okungafaniyo kwesiXhobo soNyango esenziwe ngokuhambelana neMigangatho yaso, Kwaye Hlangana neeMfuno ezifanelekileyo zoKhuseleko lweDatha eTshayina.
IZiko leKhowudi elikhuphayo liya kubonelela ngoBhalisi / uMnini weRekhodi ngeNkqubo yokuPhunyezwa koMgangatho kunye neSikhokelo sokuPhunyezwa.Ukuze Ukuququzelela oBhalisiweyo / Umnini weRekhodi ukuba abe nguMgangatho weKhowudi yeKhowudi ekhupha iziko kumaqela afanelekileyo ukukhetha okanye ukufaka isicelo, iZiko leKhowudi elikhuphayo liya kufaka iKhowudi yoMgangatho weKhowudi kwiDatabase yeSichongi esiKhethekileyo seZixhobo zoNyango kwaye ngokuGqiqisayo uyigcine.Phambi kwe-31 kaJanuwari kuNyaka ngamnye, i-Arhente eKhuphayo iyakungenisa kwi-SDA iNgxelo yoNyaka odlulileyo malunga neSaziso esahlukileyo esidalwe ngokuhambelana neMigangatho yayo.
9, Yintoni iNkqubo yoMbhalisi / uMfaki-fayile wokuphumeza uchongo olulodwa?
Inkqubo yoBhalisi / uMfaki-fayile ukuba aphumeze uchongo olulodwa lulolu hlobo lulandelayo:
Inyathelo loku-1: UMbhalisi / uMfaki-fayile uya kukhetha iZiko leKhowudi ekhuphayo ngokweMithetho kunye neMigangatho eBalulekileyo kunye neyona meko yeShishini.
Inyathelo lesi-2: Umntu oBhalisiweyo / oFayilayo wenza ukuchongwa kweMveliso ngokweMigangatho yoMbutho oKhuphayo kwaye umisela ukuBunjwa koMveliso weMveliso.
Inyathelo lesi-3: Ukususela kuMhla wokuPhunyezwa kweMithetho, ukuba ufaka isicelo soBhaliso, uBhaliso loTshintsho okanye ukuFayilwa kweZixhobo zoNyango, uMbhalisi / uMntu wokuFayila uya kuhambisa iSaziso seMveliso kwiRegistration / Filing Management System.
Inyathelo lesi-4: Umbhalisi / uMrekhoda Uyakukhetha uMthwali weDatha oLungileyo ngokweMigangatho yeZiko leKhowudi, kwaye unike isixhobo soNyango isiNxibelelalwazi seDatha esiSahluko esisiSibonelelo esisezantsi kunye nokuPhakhelwa kweNqanaba eliPhezulu okanye iMveliso yeSixhobo sezoNyango.
Inyathelo lesi-5: UMbhalisi / Umrekhoda uya Kufaka iSaziso seMveliso kunye neNkcukacha eBalulekileyo kwiDatha yeSichongi esiKhethekileyo seZixhobo zoNyango phambi kokuba iMveliso ibekwe kwintengiso.
Inyathelo lesi-6: Xa Ukuchongwa kweMveliso kunye neeNkcukacha eziNxulumene neeNkcukacha, uMbhalisi / uMrekhoda uya kuhlaziya iDatabase yeSaziso esahlukileyo seZixhobo zoNyango ngexesha.
Ixesha lokuposa: Aug-27-2019
