Yes, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) may accept US FDA approval as a reference for medical device and diagnostics registration, but similar to CE marking approval, it does not guarantee automatic approval in Japan. Japan has its own regulatory requirements, and while US FDA approval indicates compliance with US regulations, it does not automatically translate to compliance with Japanese regulations.
Manufacturers seeking to register a medical device in Japan typically need to submit a separate application to the PMDA, even if the device has already received US FDA approval. However, having US FDA approval can sometimes simplify the registration process in Japan, as it demonstrates that the device meets certain international standards for safety and performance.
As with CE marking approval, 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.
