EMERGO SUMMARY OF KEY POINTS: US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight. The new guidance applies across all aspects of FDA medical device regulation. The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.

EMERGO SUMMARY OF KEY POINTS: The US Medical Device Excise Tax (MDET) will come back into effect in 2018. Manufacturers and importers of taxable medical devices will be subject to a 2.3% tax on US sales. Years-long MDET repeal efforts by industry and Congressional allies have so far not succeeded.

EMERGO SUMMARY OF KEY POINTS: The Malaysian MDA will allow qualifying medical device market applicants to sell their products in the country pending full regulatory approval through June 2018. MDA registrants that submitted applications on or before June 30, 2016 qualify for the extended moratorium. Companies that submitted MDA registration applications after June 30, 2016 must obtain full regulatory approval before Malaysian commercialization.

医疗机器人因为自身原因而非人为错误而犯错的可能性有多大？

What is the likelihood of medical robots making mistakes on their own rather than because of human error?

EMERGO SUMMARY OF KEY POINTS: All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit. The distribution network of medical devices currently placed on the market by UK based importers must be reviewed. EU distributors currently placing UK manufactured devices on the market may have a different role. Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019. Notified Bodies are already anticipating this scenario.

Emergo重点摘要： 欧洲、英国和世界其他地区的所有经济运营者都将面临英国脱欧所带来的重大影响。 我们需要对目前由英国通过进口商投放到市场上的医疗器械经销网络重新进行审视。 目前将英国制造商的医疗器械投放到市场上的欧盟经销商们可能要开始扮演一个不同的角色。 除非达成合适的协议，否则由英国公证机构根据欧盟监管法规/指令签发的所有证书从2019年3月开始就将失效。 公证机构已经预期这种情景将会发生。

对于在临床和家庭环境中使用的某些医疗器械来说，其终端用户是以提高医疗器械使用安全性与有效性为目的的正式培训提供者。但是，并非所有的医疗器械培训项目都拥有相同实施水平。

For some medical devices used in clinical and home environments, end-users are the benefactors of formal training designed to facilitate safe and effective device use. However, not all medical device training programs are created equal.

在设计用于医疗用途的移动应用程序时，开发人员应首要关注安全性和有效性问题。