Medical Devices

Proposed partial amendments to the Regulation on Stability Test Standard for Medical Devices; (15 page(s), in Korean)

The proposed amendments to the Regulation on Stability Test Standard for Medical Devices is as follows:

1) Measurement period for stability test

- For the measurement period, at least one time point, including the last time point, can be set for long-term preservation tests and accelerated aging tests of medical devices using raw materials without physical or chemical changes, such as metals, when the data at the start of the test is replaced.

2) Clarification of test items

- Test items are divided into biological safety tests, performance tests, and other tests in accordance with the <Regulations on Medical Device Permission, Notification, Review, etc.> and <Regulation on In Vitro Diagnostic Medical Device Permission, Notification, Review, etc.>