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
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:...
Asia
The China Food and Drug Administration (CFDA) is taking steps to strengthen the innovation of medical devices and its approval system. To carry out this goal, medical device clinical assessment and exemptions need to be standardized and extended, respectively. The...
Asia
The Chinese Food and Drug Administration (CFDA) is the regulatory body in China that oversees the safety and efficiency of foods, pharmaceuticals, medical devices, and cosmetics. The CFDA recently issued regulations to enforce record-keeping of clinical trial...
Asia
China Food and Drug Administration (CFDA) recently proposed policies to streamline and accelerate drug and medical device approvals as part of its regulatory reform. Below are highlights of some noteworthy changes that impact new drug and device approval...
