YesDTC Holdings has been notified that the Japanese government agency in charge of medical device regulation has placed the ActiPatch Therapy and the Allay Menstrual Pain Therapy products manufactured by BioElectronics in the Class II category.
YesDTC Holdings is the exclusive distributor for all Bioelectronics products in Japan.
Joseph Noel, CEO of YesDTC Holdings, said: “The Class II designation will allow YesDTC to partner with other Japanese distributors that currently hold medical device licenses, thereby speeding our entry into the lucrative Japanese medical device market.
“With this designation, direct to consumer marketing without a healthcare provider’s prescription is permitted and no further clinical trials will be needed. The pain relief product vertical is very large in Japan and the demand for non-drug based therapies very strong.”
Beginning with the start of the third calendar quarter, YesDTC moved from the development phase into a revenue production phase. In addition to the Bioelectronics product line that will be marketed into Japan, YesDTC recently launched its first North American direct response television program, called Simply Music. YesDTC recently moved this program out of the test phase.
YesDTC is currently in production for its second North American program for the MediPendant personal medical alarm, which is manufactured by Medical Alarm Concepts Holdings.