推薦產(chǎn)品
3-(4-chlorophenyl)-4-phenyl-4,5-dihydro-1H-pyrazole 2-(chloromethyl)-3-methylpyridinehydrochloride 1-(2-bromo-4-methylphenyl)ethanone 3-chloroisoquinoline-4-carbonitrile 5,8-dichloropyrido[3,2-d]pyridazine 2-bromomalononitrile 2-(4-(bromomethyl)phenyl)benzo[d]thiazole 1-(bromomethyl)-3-methoxy-2-nitrobenzene 6-bromo-1H-[1,2,3]triazolo[4,5-b]pyridine 4-iodo-2-((trimethylsilyloxy)methyl)thiazole 6-iodoimidazo[1,2-a]pyridine-3-carbonitrile 2-(4-chlorophenyl)-2-morpholinoacetonitrile 4-chloro-7H-pyrrolo[2,3-d]pyrimidine 4-chloroisothiazole 5-bromo-6-chloro-1H-indole 7-chloro-3H-imidazo[4,5-b]pyridine ethyl3-(4-formylphenyl)propanoate 2,3-dibromobenzaldehyde 1-(5H-chromeno[2,3-b]pyridin-7-yl)ethanone 5H-chromeno[2,3-b]pyridin-5-one 3-chloroisoquinoline-4-carbaldehyde (E)-2-(3-oxoprop-1-enyl)benzaldehyde methyl4-formyl-3-nitrobenzoate 5,6-dimethoxy-2,2-dimethyl-2,3-dihydro-1H-inden-1-one 1-methylbicyclo[4.1.0]heptan-3-one 3-nitro-4-(trifluoromethoxy)benzaldehyde 2-hydroxyquinoline-6-carbaldehyde 2-nitro-3-(trifluoromethyl)benzaldehyde 1-(2-fluoro-4-methoxyphenyl)propan-2-one tert-butyl3-fluoro-4-oxopiperidine-1-carboxylate tert-butyl3-oxopropylcarbamate 2,2-dimethylcyclohexanone 9H-carbazole-3-carbaldehyde N,N-dimethyl-2-oxoacetamide 2-methylpent-4-yn-2-ol 3-tert-butyl-4-hydroxybenzonitrile 4-bromo-2-tert-butylphenol 1,3-dibutoxypropan-2-ol methyl4-hydroxyquinoline-6-carboxylate methyl3-cyano-4-hydroxybenzoate 4-chloro-6-methoxyquinolin-7-ol 3,4-dihydro-2H-benzo[b][1,4]oxazin-7-ol 2-(2-aminothiazol-5-yl)ethanolhydrochloride (R)-ethyl2-chloropropanoate (S)-4-amino-5-(4,4-dimethylcyclohexylamino)-5-oxopentanoicacid (1s,4s)-4-hydroxycyclohexanecarboxylicacid (S)-2-(tetrahydrofuran-3-yloxy)aceticacid (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-enol (R)-4-(hydroxymethyl)oxazolidin-2-one (S)-4-(hydroxymethyl)oxazolidin-2-one 化工資訊 近日，山東威海檢驗(yàn)檢疫局在對(duì)某企業(yè)從韓國(guó)進(jìn)口的1批塑料制品進(jìn)行現(xiàn)場(chǎng)檢驗(yàn)時(shí)，發(fā)現(xiàn)該批貨物中的12箱、1200個(gè)塑料拔罐為第一類醫(yī)療器械，但未實(shí)施備案，不符合《醫(yī)療器械監(jiān)督管理?xiàng)l例》的有關(guān)規(guī)定。威海局依法對(duì)該批貨物做退運(yùn)處理，避免其流入國(guó)內(nèi)市場(chǎng)。這是山東口岸首次退運(yùn)進(jìn)口塑料拔罐。
我國(guó)對(duì)醫(yī)療器械按照風(fēng)險(xiǎn)程度實(shí)行分類管理，第一類醫(yī)療器械實(shí)行產(chǎn)品備案管理，第二類、第三類醫(yī)療器械實(shí)行產(chǎn)品注冊(cè)管理。為加強(qiáng)對(duì)進(jìn)口醫(yī)療器械的監(jiān)督管理，保證醫(yī)療器械的安全、有效，保障我國(guó)人民健康和生命安全，檢驗(yàn)檢疫部門提醒相關(guān)企業(yè)：應(yīng)嚴(yán)格遵守我國(guó)《醫(yī)療器械監(jiān)督管理?xiàng)l例》和《醫(yī)療器械注冊(cè)管理辦法》的有關(guān)規(guī)定，避免進(jìn)口時(shí)因手續(xù)不全等原因遭退運(yùn)。進(jìn)口第一類醫(yī)療器械，應(yīng)向國(guó)務(wù)院食品藥品監(jiān)督管理部門提交備案資料和出口國(guó)主管部門允許該醫(yī)療器械上市銷售的證明文件;進(jìn)口第二類、第三類醫(yī)療器械，應(yīng)經(jīng)國(guó)家食品藥品監(jiān)督管理總局審查批準(zhǔn)后取得醫(yī)療器械注冊(cè)證。此外，進(jìn)口的醫(yī)療器械應(yīng)有中文說明書、中文標(biāo)簽，說明書、標(biāo)簽應(yīng)當(dāng)符合《醫(yī)療器械監(jiān)督管理?xiàng)l例》以及相關(guān)強(qiáng)制性標(biāo)準(zhǔn)的要求。
