Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products / 中国医疗器械杂志

By discussing the relevant requirements of the Principles of Premarket Pathways for Combination Products Guidance, 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.

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.

Research on Supervision System of Combination Product in FDA / 中国医疗器械杂志

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.

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.

Consideration for the Common Problems of the Preclinical Part in Medical Devices including Antimicrobial Agents Registration / 中国医疗器械杂志

This article summarizes and analyzes the common problems of the preclinical part in medical devices including antimicrobial agents registration. It is hoped to be helpful for researchers and manufacturers in the registration of medical devices including antimicrobial agents.

Compatibility of pre-filled syringes with pharmaceutical products / 中国药科大学学报

@#Pre-filled syringes are becoming increasingly popular for packaging and delivering system of pharmaceutical products. However, their compatibility with biotherapeutics needs to be carefully assessed. This review highlights and makes critically review on the extractables and leachables, the safety evaluation and analytical methods related to the compatibility study.