Japan Updates Labeling Requirements for Regenerative Medical Products

Over the last few months, Japan has upgraded regulations for labeling for medical devices and pharmaceuticals. In mid-September, Japan promulgated new regulations for regenerative products outlining the labeling requirements on containers for – 1. individual unit packaging, 2. the unit of packaging to be sold, and 3. multiple units of packaging (i.e. cardboard box). Labels for each of these 3 categories will vary but normally will include the product code, expiration date, and manufacturing number or manufacturing code. There are some exceptions for these requirements under different scenarios. For example, if the packaging has a small surface area, identification codes can be outlined in a document that is sold with the regenerative product. Also, regenerative products for export, for emergency use, or for products sold to other manufacturing companies will not require labeling. Distributors of regenerative products will need to register each product code with the Medical Information System Development Center.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://www.pmda.go.jp/english/safety/info-services/ctp/0003.html