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Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China .

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.

Accidental sharps injuries are a serious problem in healthcare, many healthcare workers acquire infectious diseases from bloodborne pathogens by sharps injuries during their work. The cost of injury and exposure takes an emotional and financial toll, which has attracted worldwide attention. This paper analyzed the regulatory requirements on sharps injury prevention devices in the United States and the European Union, described the classification and basic requirements of sharps injury prevention devices, evaluation of protective functions, risk identification and control to provide references for regulation and development of such products in our country.

This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.

Artificial intelligence, as the breakthrough of current information technology, is gaining importance and being applied in more and more industries. Research on the application of artificial intelligence to the medical field has gradually matured and some products have come out. Relevant products in the United States have been approved by the FDA, mainly for image-based software products. In this paper, we studied the cases of image-based artificial intelligence aided diagnosis software approved by the US FDA, and analyzed the listing routes, clinical evaluation methods and clinical data processing of representative artificial intelligence products, and summarized the clinical evaluation characteristics of FDA for image-based artificial intelligence aided diagnosis software. Finally, problems that may be encountered in the clinical evaluation of similar products in China were considered, and relevant suggestions were put forward.

Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency.At present,many countries are relatively strict in the management of high risk medical devices,especially for class Ⅲ medical devices.Taking clinical trials as examples,they cost too many human,material resources.FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process.Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States,this paper compares and analyzes the simplified status of medical device approval in China.In the end,the significance of exemption in the registration and approval process is expounded,and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.

This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.

During the practice of supervision and management of medical device in different countries, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device.

The paper compares the medical device registration system between China and FDA in U.S.A., with the main focus on the problems of design default of supervision and management in Chinese system. It analyzes the primary elements of substantial equivalence approval in medical device registration, and points out the design defaults of our medical device registration system and the basic points which need to be handled.

This paper introduces the present situation of clinical engineering in China and in the United States, and analyzes the gaps between them. Finally, from the staff's configuration and the work scope of clinical engineering, the developing trends and implementation strategies of China's clinical engineering are presented too.

The expansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices, which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current "Regulations for the Supervision and Administration of Medical Device (China)", established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to China's regulatory reform. It is suggested that when developing a new scheme of medical devices regulatory reform in China, two prominent aspects have to be considered by policy makers and regulators. Firstly, the global trend of medical devices regulations has to be taken into account. Secondly, the experiences learned from the EU and US systems should be applied to the Chinese regulatory reform in combination with the concrete practice of China.