Medical Equipment
Agent Import of Class I and Class II Medical Devices
Medical Devices Exported to Japan: Necessary Certifications and Precautions
When exporting medical devices to Japan, manufacturers need to understand and comply with a series of complex regulations and procedures. This article provides a concise guide covering Japans medical device legislation and regulatory authorities, product definitions and classifications, market access procedures, marketing authorization holder management, quality systems, post-market surveillance, and clinical trials.
PSB Record: Shanghai No.31011502009912
