What are medical devices?

Medical devices are products classified and regulated based on Japan's Pharmaceuticals and Medical Devices Act (PMD Act) for the purpose of diagnosing, preventing, or managing diseases. Each product has its own specified classification and labeling requirements.

What kind of products are in the medical devices category?

We offer a selection of items that support women's health, including general medical devices and controlled medical devices. We only list products that are designed for home use and meet quality and labeling standards.

What are the classifications of medical devices (General / Controlled / Highly Controlled)?

Medical devices are classified into categories such as general medical devices, controlled medical devices, and highly controlled medical devices, depending on their risk level. The required approvals/registrations, labeling obligations, and other management requirements vary by classification.

Are there standards for home-use medical devices?

Yes. Even medical devices designed for home use must meet approvals/registrations under the PMD Act, as well as labeling and quality standards.

What is important when choosing a medical device?

It is important to understand and use medical devices correctly. Please confirm that the instructions for use are clear, that the product meets labeling and quality standards, and follow the precautions on each product page.

What standards does fermata use for handling medical devices?

At fermata, we select medical devices based on the following criteria: they must be approved/registered for sale in Japan, meet labeling and quality standards, have clear instructions for use, and not make excessive claims of efficacy.