As data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, ...
PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...
SAN JOSE, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United ...
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
The medical technology sector has been a leader in innovation for a long time, and now the regulations are changing accordingly. As a result of digital transformation and worldwide ...
This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
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