Site na 31 Ọktoba ruo 1 Nọvemba 2023, 2nd Boao International Pharmaceutical and Device Real World Research Conference mere nke ọma na Boao, Hainan.Site n'isiokwu nke "International Real-World Data Research and Science Development of Pharmaceutical and Device Regulation", ogbako ahụ gụnyere nnọkọ zuru ezu na nkeji asatọ yiri ya na nyocha data nke ụwa n'ezie na iwu ọgwụ, ụkpụrụ ngwaọrụ ahụike, na iwu nke ọgwụ ọdịnala ndị China.
Ebe ọ bụ na 2018, Medical Device Technical Review Center nke State Drug Administration (nke a na-akpọ Ụlọ Ọrụ) emewo nyocha data n'ezie n'ọhịa nke ngwaọrụ ahụike, na-aga n'ụzọ iji jiri ihe akaebe nke ụwa na-enyere aka na ụlọ ọgwụ. nyocha, na ịkwalite nkwado na ịre ahịa nke ọtụtụ ngwa ụlọ ọgwụ na-achọ ngwa ngwa ngwa ngwa ọgwụ. ọmụmụ "Post-market Clinical follow-up of Medical Devices" ka ewepụtara, na-atụ aro ihe ndị a chọrọ na isi mmalite data, nleba anya dị mma, nhazi ọmụmụ na nyocha ọnụ ọgụgụ maka iji data n'ezie n'ụwa na nyocha nyocha ụlọ ọgwụ post-ahịa, na na-ebute ụzọ n'iwebata data ụwa n'ezie n'ime akwụkwọ nhazi mba ụwa nke IMDRF.Ụlọ ọrụ ahụ ebutewokwa ụzọ n'ịmepụta ọtụtụ akwụkwọ nhazi nke mba ụwa na nyocha ụlọ ọgwụ ma gbanwee ha ka ọ bụrụ akwụkwọ nchịkwa teknụzụ na China, na-ewulite usoro nke ụkpụrụ nduzi izugbe maka nyocha ụlọ ọgwụ nke ngwaọrụ ahụike.Ụlọ ọrụ ahụ gara n'ihu na-akwalite iji ihe akaebe nke ụwa maka ndebanye aha ngwaahịa, na-arụpụta ihe dị ịrịba ama.Ka ọ dị ugbu a, abanyela batches abụọ nke ụdị iri na atọ n'ime ngwa pilot nke data n'ezie maka ngwaọrụ ahụike, nke akwadoro ụdị asaa nwere ngụkọta ngwaahịa itoolu maka ire ahịa.
Site na ụdị pilot ndị ọzọ akwadoro maka ire ahịa, Centerlọ Ọrụ ahụ na-enyocha ngwa data nke ụwa maka ngwaọrụ ahụike mgbe niile.N'April nke afọ a, Center for Instrumental Review, yana ndị na-ahụ maka ọgwụ ọgwụ na mpaghara Hainan na nchịkwa nke Hainan Boao LeCheng International Medical Tourism Advance Zone, jikọtara ọnụ nyere "Ụdị mmejuputa maka mmejuputa nke Clinical Real-World Data Application of Medical Devices. na Hainan Boao LeCheng International Medical Tourism Advance Zone (maka mmejuputa nnwale)”.Ka ọ dị ugbu a, ụdị itoolu abanyela n'ọwa mgbasa ozi tupu oge eruo.
N'ọdịnihu, Ụlọ Ọrụ Nyocha Ngwá Ọrụ ga-arụsi ọrụ ike na-akwalite nyocha na iji data dị adị n'ezie n'okpuru nhazi nke ịmepụta usoro nyocha nke oge a 2.0, ma na-emewanyewanye ọrụ nke ihe àmà n'ezie na nyocha nke ngwaọrụ ahụike, karịsịa. ngwaahịa dị ize ndụ na ngwaahịa ọhụrụ.
Hongguan na-eche maka ahụike gị.
Hụ ngwaahịa Hongguan →https://www.hgcmedical.com/products/
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Oge nzipu: Nov-16-2023