When Does Your App Become a Medical Device?

When Does Your App Become A Medical Device?

Read the case study to learn when a health app will be classified as a medical device and how RegASK assisted a client to develop and launch their health app to the target market.

Objective

A food supplement company wanted to know if their newly developed app will be considered as a medical device and how it is subject to regulation in Japan.

Solution

  • Provided an overview of the medical devices legislation in Japan
  • Defined how the app would not be classified as a medical device
  • Recommended on design and features to be removed, added or adjusted to meet the above goal
  • Consulted with authorities on behalf of the client to validate the concept before launching the app

Results

The client was able to:

  • Be aware of the regulations and enforcement their app is subject to
  • Get a clear understanding of their app classification
  • Avoid noncompliance and potential fine by the local regulator
  • Develop a new health app and bring them to market

 

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