Japan Changes Device Labeling Requirements from Recommended to Required by Law

On September 13th, the MHLW (Ministry of Health, Labor and Welfare) issued an administrative notice requiring the display of codes (barcode display) on containers to identify medical devices and in-vitro diagnostics. Previously, the display of codes on devices was recommended,  but not required. The effective date of this new required regulation is December 1, 2022.

Up until now, the required display of codes was already recommended on almost all medical devices and IVDs marketed in Japan. This is the result of combined efforts of government authorities and various industry associations for relevant products from the viewpoint of streamlining distribution, ensuring traceability, preventing medical accidents, and improving the efficiency of medical office work.

The standard code includes a product code (GTIN) and manufacturing identifier (lot number, expiration date, etc.), and uses GS1-128 or two-dimensional code GS1 data matrix. Basically, the code needs to be displayed on (1) individual packages (minimum unit of product), (2) selling packages (minimum sales unit) and (3) collective package (Larger boxes that contain multiple selling units).

The product code is also important for accessing electronic package inserts registered in the PMDA‘s package insert (PI) database. Generally speaking, US and European companies are more advanced than Japanese companies in assigning standard codes, but companies exporting medical devices and in-vitro diagnostics to Japan should communicate with their Japanese partner companies in Japan to meet this new legal requirement.