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4個(gè)指導(dǎo)原則涵蓋了當(dāng)前醫(yī)療器械產(chǎn)品主要情形：一般性醫(yī)療器械、無(wú)菌提供的醫(yī)療器械產(chǎn)品、植入性醫(yī)療器械產(chǎn)品和體外診斷試劑產(chǎn)品。 對(duì)于一般性醫(yī)療器械產(chǎn)品（行業(yè)內(nèi)廣泛認(rèn)為是指無(wú)菌醫(yī)療器械、植入性醫(yī)療器械、體外診斷試劑以外的醫(yī)療器械產(chǎn)品），信智達(dá)工程師們對(duì)指導(dǎo)原則進(jìn)行了初步分析。 特別要注意的是，規(guī)范檢查不再...

近日，廣東在其官網(wǎng)發(fā)布《廣東省醫(yī)療機(jī)構(gòu)醫(yī)用耗材交易辦法(試行)》(征求意見稿)。該《辦法》包括總則、報(bào)名及審核、采購(gòu)目錄與競(jìng)價(jià)分組規(guī)則、入市價(jià)計(jì)算規(guī)則、競(jìng)價(jià)交易規(guī)則、議價(jià)交易規(guī)則及附則共七章23條內(nèi)容。 規(guī)定了參加醫(yī)用耗材交易的主體范圍、產(chǎn)品類別、報(bào)名條件 全省范圍內(nèi)政府辦基層醫(yī)療衛(wèi)生機(jī)構(gòu)、縣級(jí)以上公立...

2015年2月6日由Shana Leonard發(fā)表于監(jiān)管和合規(guī)上 加強(qiáng)的監(jiān)管導(dǎo)致了更多讓人畏懼和矛盾的審查環(huán)境。以下是你為下一次審查作準(zhǔn)備時(shí)需要知道的六個(gè)趨勢(shì)。 過(guò)去一兩年內(nèi)增加的監(jiān)管迫使質(zhì)量、監(jiān)管和合規(guī)部門有關(guān)人員保持警覺(jué)。保證質(zhì)量并最終保護(hù)患者和用戶是一件好事情。然而，這也是一件頭疼的事，特別是面對(duì)增加的監(jiān)管需求...

一 免于貼UDI碼的器械 　　1、 在FDA規(guī)定的實(shí)施日期之前已經(jīng)生產(chǎn)和標(biāo)記好的成品器械。在實(shí)施日期滿3年后，對(duì)于一類特定器械，該豁免情況不再有效。 2、FDA已經(jīng)豁免cGMP的I類器械。 3、個(gè)別的單次使用的器械，所有的單一版本或模型，作為一個(gè)單獨(dú)的器械包進(jìn)行銷售，在移出使用之前一直都存儲(chǔ)在其器械包內(nèi)，并且不作為個(gè)別...

Recently, Beijing, Shanghai, Fujian, Guangdong, a group focused on publicity involving medical equipment industry, law cases. 4 industry and commerce administrative penalty information publicity system shows that this industry is mainly concentrated in the illegal unfair competition, product qual...

For medical devices ring for 2015 is to monitor the bumper. In this year, large and small monitoring swept across Yixie circle. Large country, small cities and counties. But Yixie lawlessness still abound. Now 2016 is approaching, we are in the lap Yixie will face what? Production, operation or p...

According to ISO’s official website news show, after a period of two months after the vote, ISO 13485 international final draft (FDIS) standard has been overwhelmingly approved, ISO 13485 latest version will also be released the first quarter of 2016, which will have medical equipment indus...

In addition to medical device manufacturers direct force in the sales cycle, more innovative tentacles extend to the entire business chain – around the development, production and service sectors expanded three catch. Recently China Pharmaceutical Industry Information Center released the &#...

Dear manufacturers Leadership: Manufacturers sales connecting manufacturers and distributors of our bridge and link between excellent if the bridge and link play, cooperation between firms will be very happy; if this part do not, then the contradiction between manufacturers will increase, and eve...

Medical equipment import tariff, this news very early rumors, but most small partners should not be too much attention, but release relevant information according to the Ministry of Finance and other departments, to confirm compliance with the conditions of domestic enterprises tariffs and import...

According to Wei Planning Commission data, traversing nearly 20,000 hospitals, in order to more accurately position in the medical market reaction hospitals and patients in mind, choose the hospital level, hospitals and other times, number of beds, clinic visits, total income and other clinical v...

With advances in medicine, the development of medical devices will be more in line with human needs, the service of humanity. In the future, the medical device is not only innovative, but also is convenient, fast and efficient. Next, the best ten or future sales of medical devices for the invento...