4个指导原则涵盖了当前医疗器械产品主要情形：一般性医疗器械、无菌提供的医疗器械产品、植入性医疗器械产品和体外诊断试剂产品。 对于一般性医疗器械产品（行业内广泛认为是指无菌医疗器械、植入性医疗器械、体外诊断试剂以外的医疗器械产品），信智达工程师们对指导原则进行了初步分析。 特别要注意的是，规范检查不再...

近日，广东在其官网发布《广东省医疗机构医用耗材交易办法(试行)》(征求意见稿)。该《办法》包括总则、报名及审核、采购目录与竞价分组规则、入市价计算规则、竞价交易规则、议价交易规则及附则共七章23条内容。 规定了参加医用耗材交易的主体范围、产品类别、报名条件 全省范围内政府办基层医疗卫生机构、县级以上公立...

2015年2月6日由Shana Leonard发表于监管和合规上 加强的监管导致了更多让人畏惧和矛盾的审查环境。以下是你为下一次审查作准备时需要知道的六个趋势。 过去一两年内增加的监管迫使质量、监管和合规部门有关人员保持警觉。保证质量并最终保护患者和用户是一件好事情。然而，这也是一件头疼的事，特别是面对增加的监管需求...

一 免于贴UDI码的器械 　　1、 在FDA规定的实施日期之前已经生产和标记好的成品器械。在实施日期满3年后，对于一类特定器械，该豁免情况不再有效。 2、FDA已经豁免cGMP的I类器械。 3、个别的单次使用的器械，所有的单一版本或模型，作为一个单独的器械包进行销售，在移出使用之前一直都存储在其器械包内，并且不作为个别...

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...