China
The new article provides an overview of the revised guidance dedicated to registration of medical devices intended to be marketed and used in China.
China
This article was updated June 2, 2025. In this article, we will provide a comprehensive introduction to Class III medical devices, including what they are, how they are regulated, and what makes them different from other classifications. Whether you are a healthcare...
China
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
China
Overview of China’s National Medical Products Administration (formerly CFDA), their reform, medical device registration, drug registration, …
