Helping China to build a regulatory system for high-end medical devices

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…

Medical Exports Restrictions Eased when COVID-19 Hit Europe

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…

Professional Claimant Cases Drop, More Wins for Companies

Background On 2nd December 2019, the State Administration for Market Regulation (SAMR) issued the Interim Measures for Handling Complaints and Reports Concerning Market Supervision and Administration, which states that market supervision and administration agencies should not accept complaints arising from circumstances such as “purchases not made for lifestyle and consumption Read more…