Concerns of Technical Evaluation on Registration of All-inside Meniscus Suture System / 中国医疗器械杂志

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.@*CONCLUSIONS@#The difficulty of product registration and declaration of the all-inside meniscus suture system lies in the provision of pre-clinical research data of the product, and the applicant needs to strengthen the basic research ability, formulate scientific technical indicators and test methods to ensure the safety and effectiveness of the product, and also provide sufficient supporting data for the registration declaration.

Thoughts on Improving Joint Review of Combination Products / 中国医疗器械杂志

This article combines the joint review of combination products in recent years, sorts out the links and common problems in the joint review process, introduces the work carried out to optimize the joint review process of combination products, and puts forward relevant suggestions for improvement, aim to improving the work of joint review and providing reference for relevant product declaration.

Overview of the Work Related to Regulatory Scientific Research of Combination Products / 中国医疗器械杂志

Based on the research situation of the regulatory scientific research project of combination products technical evaluation in recent years, this study introduces the relevant research on how to optimize the supervision of combination products, summarizes the research progress and research results of the project, in order to promote the development of related industries.

Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression / 中国医疗器械杂志

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.

Analysis of the Common Problems of Combination Products Application / 中国医疗器械杂志

The number of combination products is increasing, and the cutting-edge and innovative technologies are constantly being used. How to evaluate combination products become difficult points. This study team summarizes the supervision conditions of the combination products and analyzes the common problems of these products application from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in these products registration.

Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System / 中国康复理论与实践

The technical review for clinical trials of implantable sacral nerve stimulation system needs to focus on the basic principles of trials, clinical institutition and design elements of clinical trial protocols.

Analysis and Study in Testing of Infrared Therapy Equipment / 中国医疗器械杂志

This article summarizes the common problems in registration and supervision testing of infrared therapy equipment, combines YY 0306-2008 Particular requirements for the safety of heat radiation therapy equipment, GB 9706.1-2007 Medical electrical equipment-Part 1:General requirements for safety, Registration technical review guidelines for infrared treatment equipment, etc. This paper analyzes and discusses the following aspects, including classification and applicable standards, performance indicators and overtemperature protection. Some suggestions and solutions are given to provide some guidance for medical equipment manufacturers in design, research and development and registration, in order to avoid the problem effectively and improve the passing rate of testing.

Digital Breast Tomosynthesis Mammography System Registration Application Data Technical Review Concerns / 中国医疗器械杂志

In this paper, the focus of technical review of the registration application data of digital Breast Tomosynthesis Mammography System was sorted out, so as to provide reference for researchers and manufacturers in China when applying for registration and preparation of such products.