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Regulatory Compliance

Wireless module medical device compliance webinar
April 11, 2019 | 9am CT In our first wireless compliance webinar , we highlighted the two main pathways to medical device wireless compliance: modular approval and system approval. Modular approval can be faster, more cost effective, and more adaptable than the system approach. However, it comes with regulatory implications that can vary from one market to the next. In this webinar, wireless compliance experts at UL provide an in-depth look at modular approval requirements so you can determine the best compliance strategy for your product. Here’s what you will learn: US FCC Modular...
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。