[FMECA and Failure Data Analysis of Domestic Wheeled Walking-Aid].

The gradual acceleration of the aging population in China has led to an increased demand for mobility aids, and the reliability of domestic wheeled walking-aid is one of their important attributes, but there is little research on the reliability of mobility aids. This paper conducts the failure mode, effects and criticality analysis on domestic wheeled walking-aid. By collecting, collating and analyzing the 26 failure modes, the key modules are the chassis and the lifting system.

[Methodological Study of Reliability Test of Percutaneous Ventricular Assist Device].

Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering.

Supraglottic airway devices: a powerful strategy in airway management.

The escalating airway management demands of cancer patients have prompted us to continually curate airway devices, with supraglottic airway devices (SADs) playing a significant role in this regard. SADs serve as instrumental tools for maintaining an open upper airway. Since the inception of the earliest SADs in the early 1980s, an array of advanced and enhanced second-generation devices have been employed in clinical settings.

Status and developmental trends in recombinant collagen preparation technology.

Recombinant collagen is a pivotal topic in foundational biological research and epitomizes the application of critical bioengineering technologies. These technological advancements have profound implications across diverse areas such as regenerative medicine, organ replacement, tissue engineering, cosmetics and more. Thus, recombinant collagen and its preparation methodologies rooted in genetically engineered cells mark pivotal milestones in medical product research.

[Study on Clinical Application and Supervision of LC-MS in Diagnosis Test].

From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.

[Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis].

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.

[Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation].

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders.

[Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT].

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science.

[Introduction and Discussion of IMDRF ].

Objective: To interpret the key contents of the guidance of issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system.

Methods: The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed.

Results: The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks.

Decellularized extracellular matrix materials for treatment of ischemic cardiomyopathy.

Ischemic cardiomyopathy (ICM) affect millions of patients globally. Decellularized extracellular matrix materials (dECM) have components, microstructure and mechanical properties similar to healthy cardiac tissues, and can be manufactured into various forms of implantable biomaterials including injectable hydrogels or epicardial patches, which have been extensively reported to attenuate pathological left ventricular remodeling and maintain heart function. Recently, dECM medical devices for ICM treatment have been approved for clinical use or studied in clinical trials, exhibiting considerable translation potential.

Bioactive Alkaloids as Secondary Metabolites from Plant Endophytic Genus.

Alkaloids represent a large family of natural products with diverse structures and bioactivities. These compounds and their derivatives have been widely used in clinics to treat various diseases. The endophytic is a filamentous fungus renowned for its extraordinary ability to produce active natural products of high therapeutic value and economic importance.

Validation of a training system for laparoscopic longitudinal suturing in lesion.

Background: A training system that allows the trainee to perform laparoscopic suturing in a realistic environment and measures the force applied to the tissue would be invaluable. This study aims to establish the construct and content validity of the training system we developed for the objective assessment of surgeons' skills.

Methods: Ten novices, 6 residents, and 6 experts performed the suturing and knot-tying task using the training system.

[Research Status and Trend of Devices for Treating Advanced Heart Failure].

Heart failure (HF),a chronic progressive disease,is a global health problem and the leading cause of deaths in the global population.The pathophysiological abnormalities of HF mainly include abnormal cardiac structure (myocardium and valves),disturbance of electrophysiological activities,and weakened myocardial contractility.In addition to drug therapy and heart transplantation,interventional therapies can be employed for advanced-stage HF,including transcatheter interventions and mechanical circulatory assist devices.

[Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures].

To investigate, analyze, and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI, as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province. The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant. The aim is to identify the main risk factors associated with the clinical use of absorbable sutures.

[Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products].

By discussing the relevant requirements of , this study analyzes FDA's review concerns for premarket pathways and predicate product selection of device-led combination products' five typical situations, in order to provide reference for Chinese manufacturers and investigators in device-led combination products registration.

[Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures].

With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.

[Discussion and Concern on Animal Study for Orthopaedic Implantable Devices].

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.

[Concerns of Technical Evaluation on Registration of All-inside Meniscus Suture System].

Objective: To summarize the product registration declaration ideas and registration technical review of the all-inside meniscal suture system, and to systematically think about of the technical review concerns of the all-inside meniscal suture system products to provide technical guidance for improving the quality of registration and application and regulatory efficiency.

Methods: Consult the public information of such products at home and abroad, and summarize the experience of registration review of such products.

Results: The technical review of the all-inside meniscus suture system registration mainly focuses on product basic information, pre-clinical research, clinical evaluation and product technical requirements.

[Regulatory Consideration for Animal Study of Medical Device].

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.

A robust MRI contrast agent for specific display of the interstitial stream.

Experimental and clinical studies have reported phenomena of long-range fluid flow in interstitial space. However, its behaviours and functions are yet to be addressed. The imaging of the interstitial stream can clarify its transportation route and allow further understanding of physiological mechanisms and clinical relevance.

[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle].

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.