New Medical Device Regulations in Japan: Guidelines for Package Inserts

Effective January 14th, Japan’s Ministry of Health, Labour, and Welfare (MHLW) issued new guidelines for medical device packaging. “The Guideline of Package Insert for Medical Devices†aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent potential adverse events. In sum, the new guidelines are geared to make usage information easier to understand for the end-user. Those companies with device products that have already been approved must revise their product inserts to comply with the new regulation by January 13, 2003.

Basic package inserts should be in compliance with the information provided on the shonin (approval) application and should include: (1) date of publication and most recent revision; (2) shonin number; (3) classification and generic name; (4) trade name; (5) warnings; (6) contraindications; (7) shape and structure; (8) performance, indication for use, efficacy and/or effectiveness; (9) instructions for use and/or handling; (1) cautions; (11) principle of operation; (12) clinical records; (13) method and duration of preservation; (14) handling instructions; (15) maintenance instructions; (16) condition for shonin; (17) packaging information; (18) major reference papers and where they might be obtained; and (19) name and address of manufacturer and/or importer.