Philippines | FDA Advisory No. 2020-1052 || Public Health Warning Against the Purchase and Use of Unnotified BioSwiss Medical Devices
The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unnotified medical devices:
(*) Taco Bandage
(*) Pineapple Bandage
The FDA verified through post-marketing surveillance that the abovementioned medical devices are not notified and the Certificates of Medical Device Notification (CMDN) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009", the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.
Since this unnotified medical devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.
CONTINUE READING ON ww2.fda.gov.ph