Scope of Verification
Verification should be conducted to determine whether the use of enzyme electrode-based blood glucose measuring devices may be affected by hydroxycarbamide when used on subjects taking hydroxycarbamide or on their specimens.
Required Labeling Information
Based on the results of the verification described above, it should be confirmed whether the following information is included in the tenpu bunsho. Depending on the actual conditions of use of the product, the wording does not need to be exactly identical to the examples below.
(1) For medical devices, ensure that the following information is included under the "Precautions for Use" section, specifically in the <Interactions (Regarding concomitant use with other drugs or medical devices)> subsection under "Caution for Concomitant Use (Precautions when used together)".
| Product name | Clinical Symptoms / Management Measures | Mechanism / Risk Factors |
| Hydroxycarbamide | If the measured value is higher than the actual glucose concentration and this measurement is used to determine the insulin dose, there is a risk of hydroxycarbamide. | If the patient is taking hydroxycarbamide, false high values may be observed. |
(2) For in vitro diagnostic medical devices, ensure that the following statement is included under the "Precautions for Operation" section, specifically in the "Interfering Substances / Interfering Drugs" subsection:
"In specimens from patients receiving Hydroxycarbamide, false high values may be observed. If these measurement results are used to determine the insulin dose, there is a risk of Hydroxycarbamide."
Revision and Information Dissemination
If the statements described in item (1) or item (2) above are not included in the current tenpu bunsho, the tenpu bunsho should be promptly revised to include the required information, and the necessary safety information should be provided to medical institutions and other relevant parties.
Reporting Requirement
For all blood glucose measuring devices using the enzyme electrode method, the results of the verifications and any revisions to the tenpu bunsho described above should be reported to to the Medical Device Safety Measures Division, Standards and Safety Measures Department, PMDA, by February 6, 2026.
Unlock Your Medical Device Potential with Us
Navigating post-market safety measures and labeling updates in Japan requires careful regulatory assessment and timely action. Qualtech brings over 26 years of experience supporting medical device manufacturers in managing PMDA safety requirements, labeling revisions, and authority communications.
Whether you are responding to safety notices or proactively reviewing product documentation, our regulatory experts can support you in maintaining compliance and minimizing market risk.
Connect with us today to ensure your products remain compliant in the Japanese market.
Reference
Self-inspection of Package Inserts for Blood Glucose Monitoring Devices, etc.