国际市场医疗器械准入

适用对象 在全球市场从事医疗器械及体外诊断设备生 产或出口的企业。 TÜV 南德意志集团与多国主管当局与检测机构 签订了 协议 离婚协议模板下载合伙人协议 下载渠道分销协议免费下载敬业协议下载授课协议下载 ，可帮助企业更快地进入当地市 场。制造商亦可从减少递交文件的数量，统 一生产的监控中获益。 美国 I 类和 II 类医疗器械需向美国食品与药品监 督管理局提交上市前通告（又名 510(k)）并 通过审核后方可在美国市场进行销售。510(k) 这一名字源自于《食品，药品和化妆品法案》 第 510(K) 章节，510(k) 文件是参照已在美国 合法上市的器械进行实质性等同说明的一套 文件，以便美国食品与药品监督管理局 (FDA) 确定器械是否安全有效。在医疗器械首次投 放美国市场，或上市器械作出重大更改时， 制造商需提交 510(k) 申请。之前 510(k) 申请 全部由 FDA 进行审核。 自 1996 年起，此系统开始允许指定的第三方 机构可以代 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf FDA 进行文件评审。TÜV SÜD 就是其中之一。当 FDA 宣布要对您进行工厂 检查时，我们也可根据 FDA 法规提供预审（如 模拟审核）。 Globalization of Medical Device Approval 国际市场医疗器械准入 Global Approval Who is this bulletin applicable to? Companies manufacturing or exporting medical devices and in vitro diagnostic medical devices for the worldwide market. TÜV SÜD enables accelerated market entry in many countries through agreements with authorities and testing institutes. Manufacturers benefit from being able to submit fewer documents or from the consolidation of production mornitoring. USA Class I and II medical devices requiring clearance for US market entry can only attain acceptance via a pre-market notification procedure, otherwise referred to as 510(k). The term 510(k) originates from section 510(k) of the Federal Food, Drug, and Cosmetic Act. A 510(k) submission is based on comparison of the new device with devices already legally marketed in the USA, which allows the US Food and Drug Administration (FDA) to determine whether a device is safe and effective. Medical device manufacturers are required to submit a 510(k) if they intend either to introduce a device for commercial distribution in the US for the first time, or to reintroduce a device that has been substantially modified. 510(k) was previously conducted by the FDA only. Since 1996, the system was revised to allow several Third Parties to perform the review process on behalf of the FDA. TÜV SÜD was among these authorities to perform the third party review for all eligible devices. When the FDA announces the Factory Inspection, we can also offer pre-audits (i.e. mock audits) based on the FDA regulation. Moreover, TÜV SÜD is a Nationally Recognized Testing Laboratory (NRTL) for the US market and provides you with testing services according to standards e.g. UL 60601-1. In addition, we will test your device according to the US-specific EMC requirements. Canada TÜV SÜD was the first registrar accredited by the Standards Council of Canada (SCC) to perform ISO 13485 CMDCAS certification. Specially trained and authorized auditors from TÜV SÜD ensure CMDCAS certification for all clients. Japan The revised Japanese Pharmaceutical Affairs Law (PAL) became effective on 1 April 2005. There are four classes of medical devices. TÜV SÜD is a Registered Certification Body (RCB) to certify class II medical devices. Products with a higher risk potential still need approval by the Pharmaceuticals and Medical Devices Agency (PMDA). Hong Kong The Medical Device Control Office (MDCO) regulates medical devices. On 26 November 2004, the DOH launched the Medical Device Administrative Control System (MDACS) as a regulatory framework for imported medical devices. TÜV SÜD has been recognized by the Department of Health as a Conformity Assessment Body (CAB) under the MDACS. The company can get the CE marking & HK Registration with one assessment. TÜV 南德意志集团是美国劳动健康部授权的 NRTL 检测实验室，可为您提供如 UL 60601-1 等 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 的检测。另外我们也可根据美国专用 EMC 标准为您提供检测服务。 加拿大 TÜV 南德意志集团是第一家获得加拿大标准委 员会 (SCC) 授权进行 ISO 13485 CMDCAS 认证 的注册机构。我们审核员均接受过专业培训 方获得授权，为所有客户提供 CMDCAS 认证。 日本 根据修订后的《日本药事法》于 2005 年 4 月 1 日起生效，医疗器械被分为四类。TÜV 南 德意志集团是日本注册认证机构 (RCB)，可 颁发二类医疗器械的相关证书。然而高风险 产品仍然需要“药品和医疗器械综合管理机 构”(PMDA) 进行批准。 香港 香港卫生署医疗仪器管制办公室 (MDCO) 负责 对医疗器械的管理。2004 年 11 月 26 日，卫 生署实施医疗仪器管制系统 (MDACS)，作为 对进口医疗器械进行管理的法规框架。 TÜV 南德意志集团已按照 MDACS 要求 对教师党员的评价套管和固井爆破片与爆破装置仓库管理基本要求三甲医院都需要复审吗 成为卫 生署授权的符合性评估机构 (CAB) 。客户进行 一次评估便可获得 CE 标志及香港注册。 For one-stop German expertise in Greater China, please contact one of these major offices: 欲在大中华区获得一站式的德国专业服务，请联络以下各主要分公司： Shanghai 上海 Tel.: +86 21 6141 0123 Beijing 北京 Tel.: +86 10 6590 6186 Guangzhou 广州 Tel.: +86 20 3832 0668 Shenzhen 深圳 Tel.: +86 755 8828 6998 For more details of other countries, pls. refer to our website: 如需更多国家准入信息，可参考我们的网站： http://www.tuev-sued.de/uploads/images/1258035495473976070765/Globalization of Medical Device Approval.pdf www.tuv-sud.cn