Yes, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) may accept CE marking approval as a reference for medical device and diagnostics registration, but it does not guarantee automatic approval. Japan has its own regulatory requirements, and while CE marking indicates compliance with European regulations, it does not automatically translate to compliance with Japanese regulations.
To register a medical device in Japan, manufacturers typically need to submit a separate application to the PMDA, even if the device has already received CE marking approval. However, having CE marking approval can sometimes simplify the registration process in Japan, as it demonstrates that the device meets certain international standards for safety and performance.
It's important for manufacturers to consult with regulatory experts or local representatives familiar with Japanese regulations to understand the specific requirements and process for registering their medical devices in Japan.
