China
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 professional or simply interested in...
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
A Class III medical device is a device that is intended for use in the diagnosis, cure, treatment, or prevention of disease and is also intended to affect the structure or any function of the body. These devices are generally the most complex and pose the greatest...
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
The Center for Medical Device Evaluation (CMDE), the Chinese regulating authority, issued updated regulations on the registration of medical devices. CMDA Amended Regulations on Filings The first document issued by the CMDE covers certain aspects related to the review...
China
What is the NMPA The China Food and Drug Administration (CFDA), or the now National Medical Products Administration (NMPA), is the Chinese regulating body that oversees pharmaceuticals, medical devices, and cosmetics. Some of their tasks and responsibilities include:...
