“Fetal Monitor iCTG” has obtained PMDA – Japan’s Pharmaceutical Affairs regulatory approval. We are also ISO13485 certified. Please contact us if you are a Distributor in the country where Japan’s Pharmaceutical Affairs regulatory approval is valid. Our products are also already registered with the Thai FDA. We are under preparing to acquire US FDA as well as FDA of other countries.
We are also looking for doctors who would like to have a clinical trial of our device.