Japanese Regulators Relax Medical Device Stability Testing Requirements

Japan’s Ministry of Health, Labour and Welfare has exempted stability test report requirements for some medical devices submitted to the Pharmaceutical and Medical Devices Agency (PMDA) for registration.

Stability testing remains a requirement, however, for medical devices using new or innovative materials with little or no stability data, or that are structurally different enough from their predicate devices to require verification of stability. Testing requirements also remain for the following device types:

• Biological products
• Medical devices containing biological products
• Devices containing radioactive materials
• Devices containing pharmaceutical products
• Dedicated analysis systems using main reaction
• Devices with special storage requirements such as refrigeration

For medical devices now exempt from PMDA stability testing requirements, manufacturers must still provide in their Japan medical device registration applications descriptions of their products’ shelf lives in cases where a shelf life is less than three years. All manufacturers and sponsors should also be prepared to verify stability of their devices and maintain pertinent documentation in case such data is requested by regulators or quality system auditors.

In instances where a manufacturer of a device already registered with the PMDA changes its product’s shelf life, that manufacturer should submit a Minor Change Application.