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Regulatory Compliance

Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique challenges because their products are subject to HFE requirements for devices, drugs, cosmetics, or more. In this webinar, we will provide an overview of HFE considerations for combination products. You will learn: Introduction to Human Factors Engineering (HFE) Regulatory imperative for applying HFE (per FDA, IEC 62366, MHRA) Combination product specific guidance for new drugs, generics, and interchangeable...
Learn about the Japanese PMDA regulations which apply to medical devices
The following documents were published by Japan's Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format.
Learn about the Chinese CFDA regulations which apply to medical devices
以下列出中国国家食品药品监督管理局(CFDA)对於医疗器械公司会造成重大影响的文件,不过所提供的文件都只限於中文版。
Learn about the Chinese CFDA regulations which apply to medical devices
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the CFDA only makes these available in Chinese.
Learn about the Health Canada regulations which apply to medical devices
下列文档是加拿大卫生部医疗器械相关规定,也是我们能够提供的服务。
Learn about the Health Canada regulations which apply to medical devices
We have assembled the following documents about Medical Device Regulations from Health Canada as a service to the medical device community.