The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical devices:
- Smileplus Bandage Children’s Cartoon
- Smileplus Bandage Children’s Colored for Kids
The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act 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 from FDA are prohibited.
Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The use of such violative product may pose potential health hazard to the consuming public.
In light of the above, the public is advised not to purchase this product in the market. Moreover, the public is advised to always check if a medical device is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing-in the name of the product before purchasing.
All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.
All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.