If you are thinking about entering the Japanese market for the first time, understanding the PMDA’s regulatory requirements can be overwhelming. Information about medical device regulations on the PMDA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer.
To help medical device manufacturers who want to export medical devices to Japan, we assembled a packet that includes the basic information you need before deciding to enter the Japanese market. It outlines the registration requirements and ongoing obligations to maintain compliance.
If you set aside just one hour to read/watch these items, we guarantee you will have a MUCH better understanding of how the PMDA’s regulatory process works.
No salesperson will call you
Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend mo
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