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Regulatory Compliance

Conducting a medical device PMCF webinar
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting structured post-market data about your device. A PMCF study examines how your device performs when used as intended to gain verification of the clinical performance of your product and to collect safety information. Under the MDR, manufacturers are expected to perform more PMCF studies throughout the device lifecycle. Based on their opinion of your data supporting the safety and performance of the product, your Notified Body can require a PMCF study at any time, so it’s...
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
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
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 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.
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。