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Ukuphonononga ubungqina behlabathi lokwenyani ukunceda uvavanyo lweklinikhi

Ukususela kwi-31 ngo-Oktobha ukuya kwi-1 kaNovemba ka-2023, i-2nd Boao International Pharmaceutical and Device Real World Conference yoPhando yabanjwa ngempumelelo e-Boao, eHainan.Ngomxholo othi "UPhando lweDatha yeHlabathi yeNgqondo kunye noPhuhliso lwezeNzululwazi yezoPhando kunye noLawulo lweSixhobo", inkomfa yayiquka iseshoni yodliwano-ndlebe kunye neeforamu ezisibhozo ezifanayo malunga nophando lwedatha yehlabathi lokwenene kunye nokulawulwa kweziyobisi, ukulawulwa kwezixhobo zonyango, kunye nokulawula amayeza emveli aseTshayina.

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Ukusukela ngo-2018, iZiko loPhononongo lwezobuGcisa lweSixhobo sezoNyango loLawulo lweZiyobisi likaRhulumente (emva koko libizwa ngokuba liZiko) lenze uphando lwedatha yelizwe lokwenyani kwicandelo lezixhobo zonyango, lihamba ngendlela yokusebenzisa ubungqina behlabathi lokwenyani ukunceda kwiklinikhi. Uvavanyo, kunye nokukhuthaza ukuvunywa kunye nokuthengiswa kwenani lezixhobo zonyango ezifunwa ngokungxamisekileyo.2021 NgoMeyi ka-2021, iZiko likhokele uphando lweForam yoLawulo lweZixhobo zoNyango lwaMazwe ngaMazwe (IMDRF) ngoMeyi ka-2021, i-IMRFF ekhokelwa yi-IMDRF. Uphononongo "I-Post-market Clinical Tracking of Medical Devices" yakhululwa, iphakamisa iimfuno kwimithombo yedatha, uvavanyo lomgangatho, uyilo lokufunda kunye nohlalutyo lwamanani okusetyenziswa kwedatha yehlabathi lokwenyani kwizifundo zokulandela ikliniki emva kokuthengisa, kunye ukukhokela ekuziseni iinkcukacha zehlabathi lokwenene kumaxwebhu olungelelwaniso lwamazwe ngamazwe e-IMDRF.Iziko liye lathatha ukhokelo ekuqulunqeni inani lamaxwebhu olungelelwaniso lwamazwe ngamazwe kuvavanyo lweklinikhi kunye nokuguqula abe ngamaxwebhu obugcisa be-normative e-China, ekuqaleni ukwakha inkqubo yemigaqo yesikhokelo jikelele yovavanyo lweklinikhi yezixhobo zonyango.Iziko liye laqhubeka nokukhuthaza ukusetyenziswa kobungqina behlabathi bokwenene bokubhaliswa kwemveliso, kunye neziphumo eziphawulekayo.Ukuza kuthi ga ngoku, iibhetshi ezimbini zeentlobo ze-13 zibandakanyiwe kwisicelo sokulinga idatha yelizwe lokwenyani kwizixhobo zonyango, apho iintlobo ezisixhenxe ezineemveliso ezilithoba zivunyiweyo ukuba zithengiswe.

Ngeentlobo ezininzi zokulingwa ezivunyiweyo ukuthengiswa, iZiko lihlola ukusetyenziswa kwedatha yehlabathi lokwenyani kwizixhobo zonyango rhoqo.Ngo-Epreli kulo nyaka, iZiko loPhononongo lweZixhobo, kunye noLawulo lweZiyobisi lwePhondo laseHainan kunye noLawulo lwe-Hainan Boao LeCheng International Medical Tourism Advance Zone, ngokudibeneyo bakhuphe "Amanyathelo okuPhunyezwa kweClinical Real-World Data Application of Medical Devices. eHainan Boao LeCheng uMmandla oPhambili wezoKhenketho lwezoNyango lwaMazwe ngaMazwe (ukuze kuphunyezwe uVavanyo)”.Okwangoku, iintlobo ezilithoba ziye zangena ngokusesikweni kumjelo wangaphambi konxibelelwano.

Kwixesha elizayo, iZiko lokuPhonononga i-Instrument liza kukhuthaza uphando kunye nokusetyenziswa kwedatha yehlabathi lokwenene phantsi kwesakhelo sokwakha inkqubo yokuhlaziywa kwenkqubo ye-2.0, kwaye iphucule ngakumbi indima yobungqina behlabathi bokwenene ekuvavanyeni izixhobo zonyango, ngakumbi. iimveliso ezinomngcipheko ophezulu kunye neemveliso ezintsha.

 

Ukhathalelo lwaseHongguan malunga nempilo yakho.

Bona ngakumbi Hongguan Product→https://www.hgcmedical.com/products/

Ukuba kukho naziphi na iimfuno zezinto ezinokusetyenziswa zonyango, nceda uzive ukhululekile ukuqhagamshelana nathi.

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Ixesha lokuposa: Nov-16-2023