Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.

Discussion and Concern on Animal Study for Orthopaedic Implantable Devices / 中国医疗器械杂志

In recent years, new orthopaedic implantable devices continue to emerge, which require higher requirements for technical evaluation. Animal study is an important part of the research and development process for the new orthopedic implantable devices, which provides relevant evidence for product design and stereotyping. By introducing the purpose of animal study, and the application of 3R principle (replacement, reduction, refinement) in this field, we summarize the concern on the animal study, in order to provide reference for the development and research of new orthopedic implantable devices and biomaterials. At the same time, the application of evidence-based research methods such as systematic review in the field is introduced, which provides new tools and approaches for the technical review and regulatory science.

Regulatory Consideration for Animal Study of Medical Device / 中国医疗器械杂志

Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.

Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander / 中国医疗器械杂志

With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.

Discussion on Technical Review Guidance for Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues / 中国医疗器械杂志

OBJECTIVE@#This paper introduces the key content and background of Technical Review Guidance for the Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues.@*METHODS@#The core contents and importance of the construction of personalized design validation and verification and additive manufacturing system are described respectively.@*RESULTS@#The personalized design needs to be carried out under the control of interactive cooperation between healthcare professional and engineer. And the performance of personalized device must be validated and verified completely. At the same time, in view of the particularity of the quality management system of additive manufacturing, the technical focus is expounded.@*CONCLUSIONS@#New ideas and methods shall be used in evaluate and administrate personalized additive manufacturing medical device.

Classification of emotional brain networks based on weighted -order propagation number / 生物医学工程学杂志

Electroencephalography (EEG) signals are strongly correlated with human emotions. The importance of nodes in the emotional brain network provides an effective means to analyze the emotional brain mechanism. In this paper, a new ranking method of node importance, weighted -order propagation number method, was used to design and implement a classification algorithm for emotional brain networks. Firstly, based on DEAP emotional EEG data, a cross-sample entropy brain network was constructed, and the importance of nodes in positive and negative emotional brain networks was sorted to obtain the feature matrix under multi-threshold scales. Secondly, feature extraction and support vector machine (SVM) were used to classify emotion. The classification accuracy was 83.6%. The results show that it is effective to use the weighted -order propagation number method to extract the importance characteristics of brain network nodes for emotion classification, which provides a new means for feature extraction and analysis of complex networks.

Consideration for the Common Problems of Combination Products Attribution Defnition / 中国医疗器械杂志

This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.

Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.