The Food and Drug Administration (FDA) received reports regarding rampant online selling of the infrared thermometer for medical use in different online platforms.
A Certificate of Product Registration is required for infrared thermometers prior to distribution and sale. In view of this, FDA hereby advises all healthcare professionals and the public to purchase and use only infrared thermometer for medical use with Certificate of Product Registration (CPR) issued by FDA.
All concerned establishments are warned not to distribute, advertise, or sell unregistered infrared thermometer until a CPR 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 only registered infrared thermometer are sold or made available in the market or in their areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of unregistered above-mentioned medical device 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) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:->FDA Advisory No.2020-434