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Regulatory Compliance

Cellular technology adds exciting new possibilities for healthcare but can also bring regulatory burden. When you incorporate a wireless module into your medical device, you must comply with wireless technology Type Approval requirements that apply in over 100 countries. And, there is no one-size-fits-all approach, as regulatory and testing requirements can vary by market based on your device’s technology. Despite these obstacles, the benefits of cellular technology outweigh the challenges of certifying a wireless product, even in the most challenging markets. In this one-hour webinar,...
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。