Category: China Market Updates

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The regulation will take effect on

The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process”

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2025. These updates are presented by China Med Device, LLC, your partner

What Devices Received HUD Designation As examples, the following devices, categorized by indications, have been designated HUD status: Indication Device Manufacturers Year of HUD Designated Cardiology Realheart® Total Artificial Heart

FDA’s Humanitarian Use Device (HUD) program offers a crucial lifeline to patients with rare conditions who might otherwise be left behind in the march of technological progress. In recent years,

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med Device, LLC, your partner in

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in February 2025. These updates are presented by China Med Device, LLC, your partner in

The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025, a revised version of the same-named regulation implemented on June 1, 2021. It

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

The General Office of the State Council issued the “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry” on January