Public Health Advisory on the Purchase and Use of the Infrared Thermometer for Medical Use Offered for Sale Online
The FDA Advisory No. 434-20 issued on March 20, 2020, warns healthcare professionals and the public about the online sale of infrared thermometers for medical use without proper certification. It emphasizes that a Certificate of Product Registration (CPR) is mandatory for the distribution and sale of these devices. The FDA advises purchasing only those thermometers with a valid CPR and warns establishments against selling unregistered products, as regulatory actions will follow. Additionally, the Bureau of Customs is urged to prevent the entry of unregistered devices, and the public is encouraged to report any violations through the FDA's online reporting facility.
Law Information
- Reference Number
- FDA Advisory No. 434-20
- Date Enacted
- Subcategory
- Food and Drugs Administration of the Philippines
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
March 20, 2020
FDA ADVISORY NO. 434-20
| TO | : | All Healthcare Professionals and the General Public |
| SUBJECT | : | Public Health Advisory on the Purchase and Use of the Infrared Thermometer for Medical Use Offered for Sale Online |
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. HTcADC
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.
To report any sale or distribution of unregistered medical 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.
(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General
Cite This Law
Public Health Advisory on the Purchase and Use of the Infrared Thermometer for Medical Use Offered for Sale Online, FDA Advisory No. 434-20, Mar 20, 2020 (Philippines)
Public Health Advisory on the Purchase and Use of the Infrared Thermometer for Medical Use Offered for Sale Online, FDA Advisory No. 434-20 (Phil. 2020)
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