What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The Gastroenterology and Urology Devices Panel of the US Food and Drug Administration's (FDA's) Medical Devices Advisory Committee deliberated yesterday on the classification of 4 categories of ...

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 ...

Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Market, by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, ...

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 ...

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. On ...