Research on the Classification Management of Digital Therapeutics Software / 中国医疗器械杂志

According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.

Single-use Medical Devices Re-processing: Regulatory Status Quo / 中国医疗器械杂志

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.

Scientific Opinion on the Regulatory Status of 1,3-Dimethylamylamine (DMAA).

1,3-Dimethylamylamine (DMAA) is a pressor amine often found in food supplements for athletes at dosages of 25-65 mg. Historically, the compound has been used as a nasal decongestant but its oral application is largely unstudied leaving the regulatory status of such food supplements as unlicensed medicines undetermined. We therefore reviewed the literature on DMAA and similar amines in order to deduce an effective oral dosage. Based on our findings we conclude that oral preparations with >4 mg DMAA per dose unit should be considered as effective as a bronchodilator. Food supplements that exceed that limit are in fact subject to the Medicines Act and require licensing. Dosages higher than 100-200 mg are expected to cause serious adverse events.