Dear Network,
I am looking for someone who can give me advice on the Japanese Regulations.
The device is not qualified as a medical device in Japan, would like to know what extra Standards, Regulations that the manufacturer needs to follow.
If you know any Consultants who can help, please let me know, many thanks.
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Sally Chan
Regulatory Affairs Manager - EU, US, China
https://www.linkedin.com/in/chan-wing-shan-sally-1a60b099/------------------------------