01 Policy Support
In recent years, China has attached great importance to the development of AI. The Central Committee of the Communist Party of China, the State Council, and departments such as the Ministry of Science and Technology and the more…
01
General Overview
According to the statistics of the Data Center of the High – end Medical Device Institute, as of June 30, 2025, there were 35,359 medical device manufacturing enterprises within the territory of China, an increase of 5.86% more…
On July 6, 2025, the Treasury Department of the Ministry of Finance of China issued the “Notice on Taking Relevant Measures for Medical Devices Imported from the EU in Government Procurement Activities” (Caiku [2025] No. more…
Recently, the Beijing Municipal Drug Administration released the Q&A related to “New 300 Questions on Beijing Medical Device Review and Inspection (Volume II)”, which mainly focuses on six sections: active products, passive products, clinical inspection products, medical device quality management system, classification and definition, and innovative medical devices. more…
On the 10th, in order to further strengthen the supervision and management of in vitro diagnostic reagent products related to next-generation gene sequencing, the National Medical Products Administration organized and formulated the “Guidance Principles for the Classification and Definition of In Vitro Diagnostic Reagents Related to Next-generation Gene Sequencing” (hereinafter referred to as the Guidance Principles), which is hereby released. more…
This report aims to conduct an in – depth analysis of the clinical demand, market size, localization rate, and competitive landscape of domestic cardiac electrophysiology (ablation catheters) in 2024. more…
Innovative medical devices refer to those that legally hold invention patents for core product technologies in China. The main working principles or mechanisms of action of the products are first developed domestically. The more…
On April 28th, the National Medical Products Administration released a significant document – the “Quality Management Specifications for the Online Sale of Medical Devices” (hereinafter referred to as the “Specifications”), more…
