Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
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
DRG (Diagnosis-Related Group) and DIP (Diagnosis-Intervention Packet) have been introduced since 2021 as payment models implemented by the Chinese healthcare system, aiming to standardize and control hospital expenses. The central
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in November 2024. These updates are presented by China Med Device, LLC, your partner in
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2024. These updates are presented by China Med Device, LLC, your partner
The NMPA released the “Announcement on Further Clarifying Matters Related to the Domestic Production of Imported Medical Devices in China (Draft)” on November 4, 2024. Feedbacks need to be submitted