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IMPACT ANALYSIS: U.S. advisory warns on Hong Kong risk but vague on enforcement inclinations


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HONG KONG/NEW YORK(Thomson Reuters Regulatory Intelligence) - The U.S. departments of State, Treasury and Homeland Security recently issued a joint advisory warning U.S. companies in Hong Kong of escalating financial, legal and reputational risks associated with doing business in the territory. The advisory attributes “many” of these risks to implementation of the National Security Law (NSL) and other recent legislative changes that have taken place in Hong Kong.
A Stock Exchange of Hong Kong (HKEX) sign is seen at the 2020 China International Fair for Trade in Services (CIFTIS) in Beijing, China September 4, 2020.
The NSL grants additional investigative and enforcement powers to law enforcement agencies in Hong Kong and Mainland China, a development that has stoked concerns that businesses, and their staff, could be exposed to heightened regulatory risk. In the advisory(LINK: here), the U.S. government warned businesses in Hong Kong that they are at ri ....

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FDA's CDRH posts list of proposed guidance development in 2016 as well


Photo source: iStock/AlexLMX
FDA s Center for Devices and Radiological Health has posted a list of the guidance documents it plans to publish in fiscal year 2016 as either final or draft guidances. It has also posted a list of previously issued final guidances for which the center is interested in receiving external feedback on whether they should be revised or withdrawn.
Several of these guidances could be of interest to medical device packaging professionals. CDRH asks that comments on any of these guidance documents be submitted to docket FDA-2012-N-1021.
FDA has divided the potential guidance documents that could be published as either final or draft into an A list and a B list. The A list is a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year, whereas the B list is a list of device guidance documents that the Agency intends to publish as resources permit e ....

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