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2014年8月1日，美国食品和药物管理局（FDA）宣布2015年的制药和医疗设备申请费。 这些费率将在2014年10月1日至2015年9月30日有效。对于医疗器械，上市前申请（PMA）将耗资250，895美元；510（K）上市前通知将提高到5018美元。 Read More

As PBM noted in a July news brief, Chinas revised Regulations on the Supervision and Administration of Medical Devices went into force on June 1, 2014. On August 1, the China Food and Drug Administration (CFDA) released additional detailed information on implementing... Read More

On August 1, 2014, the U.S. Food and Drug Administration (FDA) announced the fiscal year 2015 user fees for pharmaceutical and medical device companies. These rates will be effective from October 1, 2014 through September 30, 2015. For medical devices, a premarket... Read More

美国FDA也发布了几份关于复方药物产品的文件，包括： 一份有关符合外包服务设施的现行cGMP（current good manufacturing practice； CGMP）条件的临时指南草案。 两个联邦注册通知，通知说可以用来做复方药物产品的活性药物成分（active pharmaceutical ingredients；API）的提名程序要被重新打开。 一个规则提议，要修正成不了复方药物的药物产品的列表。 对要做复方药物的药店或个人的最后指导。 Read More

The past several months have seen several announcements by the Malaysian Medical Device Authority (MDA). First launched in mid-2013, the online Medical Device Centralized Application System (MEDCAST) was expanded to support in vitro diagnostic (IVD) device submissions in May 2014. The MDA... Read More

In late June 2014, the FDA released a draft guidance entitled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. The guidance announced that these types of systems and devices would no longer need to comply with some... Read More

在过去的几个月，马来西亚医疗器械管理局（MDA）发布了几条消息。2013年年中，首次网上推出，医疗器械集中式应用系统（MEDCAST）。于2014年5 月支持在体外诊断（IVD）仪器的申请。 MDA公布了体外诊断试剂的12步注册程序。 另外2014年5月，MDA的颁布5项新政策，进一步落实医疗器械法： Read More

On June 1, 2014, China's amended "Regulations on the Supervision and Administration of Medical Devices" went into effect. Class I medical devices -- domestic and imported -- no longer need to be registered with the China Food and Drug Administration (CFDA). Instead,... Read More

2014年6月1日，中国的修订后的"医疗器械的监督管理办法"正式生效。国产和进口第一类医疗器械不再需要在中国食品药品监督管理局（CFDA）注册。然而，第一类医疗器械必须通知当地的食品药品监督管理局。外国医疗器械制造商应指定一名中国代表代理人提交有关产品的注册材料。 Read More

The Indian medical device market is worth about $4.3 billion dollars. It is expected to grow to about $12 billion dollars by 2022. More and more Western device companies are registering their products in India. For registration renewals, the DCGI is now... Read More