Background Due to the limited workload capacity of testing institutes and relevant government departments, many medical devices were unable to fulfil the testing and registration requirements under the State Council’s Decree 739, Measures for the Supervision and Administration of Medical Device Manufacturing, by the deadline of 1st May 2023. This posed Read more…
Background High-end medical devices—such as software/artificial intelligence (AI)-based medical devices—continue to advance rapidly, and are now widely used in healthcare systems around the globe. However, the current regulatory system in China is still based on high-risk, hardware-based medical devices, which causes problems for manufacturers of software and AI-based high-end medical Read more…
Background Since March 2020, Europe has been struggling to contain COVID-19, with some countries seeing multiple waves of outbreaks, causing the demand for medical supplies to soar. On 31st March 2020, the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC) and the National Medical Products Administration jointly issued Read more…
Allow faster access by Chinese patients to new and innovative medical devices.
Disposable medical devices excluded from Two-invoice System in 2 provinces and 2 tier-1 cities
