Applications for the registration of lumbar massagers at the PMDA in Japan can be submitted through the ** system designated by the PMDA. Here are the general steps:
Log in to the PMDA Online Portal: Access PMDA's portal, commonly known as the PMDA e-Submission Portal. This portal provides information on medical device registration and related businesses.
Create an account: If you haven't already registered on the PMDA Online Portal, you'll need to create one. This usually involves providing the necessary information, and setting up login credentials.
Visit the application page: Once you are logged into your account, you can access the relevant medical device registration application page. This page will provide detailed guidelines and requirements to help you fill out your application.
Fill out the application**: An electronic version of the application may be provided**, and you will need to fill in all the necessary information. Ensure that accurate and complete information is provided in accordance with the requirements of the PMDA.
Upload Documents: Upload the prepared technical files and other necessary documents to the system. The format and requirements of the document may be detailed in the guidelines of the PMDA.
Payment fees: Depending on the product's classification and registration fees, payment options may be available. Make sure to pay the relevant registration fees.
Submit an application: Review all provided information and documents to ensure that nothing is missing. Once completed, submit the registration application through the system.