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Regulatory Compliance

How device companies can prepare for a no-deal Brexit
February 20, 2019 | 9am CT Emergo’s regulatory experts in Europe are closely monitoring developments in British Parliament to assess how potential Brexit outcomes could affect the medical devices industry. As Brexit Day approaches, a no-deal (or Cliff Edge) Brexit is emerging as a realistic scenario even though it would bring serious, immediate consequences for all industries operating in the UK and mainland Europe. A sudden hard border between the UK and EU could cause substantial disruption in the medical device sector, with implications for device manufacturers, healthcare providers, and...
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。