The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered health related device:
The FDA verified through post-marketing surveillance that the above mentioned health related
device is not registered and the Certificate of Heath Related Device Registration (CHRDR) has not yet
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 unregistered health related device has not gone through evaluation process of the FDA,
the agency cannot assure its quality and safety.
In light of the foregoing, the public is advised not to distribute, advertise the violative product in the market.
All concerned establishments are warned not to distribute, advertise, or sell the said violative
health related device until CHRDR is issued, otherwise, regulatory actions and sanctions shall
be strictly pursued.
All FDA Regional Field Offices and Regulatory Enforcement units in coordination with law
enforcement agencies and Local Government Units are requested to ensure that this product is
not sold or made available in the market or areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of this unregistered product.
For more information and inquiries, kindly contact the FDA Center for Device Regulation,
Radiation Health and Research through e-mail at [email protected],or call (02) 857-1900 loc.
To report any sale or distribution of Unregistered health device, the Online reporting Facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.