To strengthen the classification management of medical devices, standardize the dynamic adjustment of the “Medical Device Classification Catalog” (herein referred to as the “Category Catalog”), and formulate this work procedure in accordance with “Regulations on the Supervision and Administration of ...
For the change of product management category due to the dynamic adjustment of the Medical Device Classification Catalogue, the medical device registrant shall implement unique identification in accordance with the requirements of the adjusted management category. Medical device operating enterprises shall ...
In the first half of this year, the State Food and Drug Administration adjusted some of the contents of the "Medical Device Classification Catalog". Spinal probes, clip devices, catheter sterilization connectors, vascular puncture needles, catheter sheaths, dilators, Y-connection valves, high-pressure...
Apply to: This guideline applies to the class II Surgical Astral Lamp. Surgical Astral Lamp (The code in the ‘Medical Device Classification catalog’ is 6854-13.1) is providing visible light for the operation field or patients during the operation process. Not apply to:Operation illuminating lam...
In order to further deepen the reform of the medical device review and approval system, and based on the actual development of the medical device industry and the supervision work, the NMPA organized a dynamic adjustment of the "Medical Device Classification Catalog", selected a batch of...
SaMD Classification Determine classification of a software using NMPA Medical Device Classification Catalog is the first step. In general, if a software has clinical data auto-analysis ability based on deep learning or artificial intelligence algorithm, or aids in diagnosis for medical decision, it is...
In addition to in vitro diagnostic reagents, registered imported medical devices involve products in 21 sub-categories of the "Medical Device Classification Catalog." The top five registered imported medical devices are mainly: dental devices, medical imaging devices, passive implant devices, nerve and...
In addition to in vitro diagnostic reagents, registered imported medical devices involve products in 21 sub-categories of the "Medical Device Classification Catalog." The top five registered imported medical devices are mainly: dental devices, medical imaging devices, passive implant devices, nerve and...
Apply to: This guideline applies to the invasive blood glucose meter. And according to the ‘Medical Device Classification Catalog’ the management code is 6840. The glucometers with movable terminal that transmission through the built-in Bluetooth, WIFI, infrared and etc. are also conformed to ...
Function, principle, methods of this code and its relationship with medical device nomenclature, classification, classified catalog and "UDI" is proposed. ... W Yue - 《Chinese Journal of Medical Instrumentation》 被引量: 12发表: 2012年 IEEE Standard for Health Informatics - Point-Of-Care Medica...