China authorities, including the National Health Commission (NHC), Ministry of Education, Ministry of Science and Technology and National Administration of Traditional Chinese Medicine, released the Measures for the Ethics Review of Life Sciences and Medical Research Involving Human on Feb 18, 2023. more…
On April 17th, the launch meeting of the “14th Five Year Plan” National Key R&D Plan “Diagnosis and Treatment Equipment and Biomedical Materials” key special projects “Construction of Quality Evaluation Technology and Clinical Application Quality Assurance System for Radiation more…
In the Chinese Medical Device Classification Directory, Part 16 is ophthalmic instruments, including all kinds of ophthalmic instruments and related auxiliary instruments used in ophthalmic examination, operation, treatment and protection, excluding ophthalmic rehabilitation training more…
On April 19, 2023, the State Medical Products Administration (NMPA) released the Annual Statistical Data of Drug Supervision and Administration (2022), which disclosed the acceptance, approval and supervision of medical devices. more…
The statistical products in this paper are molecular biology analysis equipment, including subdivided varieties: molecular biology analysis equipment accessories, sanger sequencing instrument, nucleic acid amplification analyzer, nucleic acid molecular hybridization instrument, gene sequencer, nucleic acid amplification instrument, other molecular biology analysis equipment more…
Recently, in order to strengthen the management of medical device clinical trial institutions (hereinafter referred to as institutions) and standardize their supervision and inspection work, in accordance with relevant more…
For manufacturers operating medical devices in China, NMPA has issued the deadline for submitting the 2022 Annual Quality System Self-Inspection Report to China’s provincial level NMPA on March 31st, 2023. more…
According to the announcement, the ninth batch of excellent domestic medical equipment product catalog selection will be launched recently, the ninth batch of selection of 13 categories, including: Ultrasonic endoscope system, mobile special medical magnetic resonance imaging equipment for infants, artificial intelligence assisted imaging diagnosis (fracture), minimally invasive breast incision equipment, near-infrared brain oxygen saturation monitor, non-invasive hemodynamics monitoring system, dynamic brain electrical impedance imaging system, high flow respiratory more…
Recently, according to the Medical Device Registration and Archival Management Measures, In Vitro Diagnostic Reagents Registration and Archival Management Measures Medical Device Clinical Trial Institutions Conditions and Archival Management Measures , Medical Device Clinical Trial Quality Management Standards and other relevant provisions, The Comprehensive Department of the NMPA publicly solicits opinions on the Supervision and Inspection Points and Judgment Principles of Medical Device Clinical Trial Institutions (Draft for Soliciting Opinions). more…
