Many Western medical companies are coming out with unique software with healthcare applications. Some stand-alone software programs in Japan are classified as program medical devices. Program medical devices generally include a computer program (intangible) or tangible recording media (any magnetic tape, disk, or other physical medium containing the Source Codes). In contrast to program medical devices, regular medical devices with software components are usually tangible equipment or materials. An example of a CDx program medical device is when tissue samples are collected in Japan and sent to the West for analysis (run through software applications overseas) and then a report is sent back to Japan with certain results/data.
On March 31, 2021, the Ministry of Health, Labor, and Welfare published the first “Guidelines for Program Medical Device Applicability” and the first “Program Medical Device Case Database” for the purpose of clarifying and refining the judgment of applicability to medical device programs. The guidelines provided a detailed explanation of the basic concept of the applicability of program medical devices.
On July 11, The MHLW published a new program medical device database. The Program Medical Device Case Database is a collection of cases regarding the applicability of various programs to medical devices. This database contains 59 types of health management programs. The database shows: (1) Intended use, (2) Target audience (healthcare professionals/general users), (3) Outline of the program, and (4) Basis for determining the applicability to medical devices, for each of the 52 programs.
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.