THE Food and Drug Administration (FDA) has warned all healthcare professionals and the public not to purchase and use the unnotified medical device product "AideLai Disposable Face Mask."
In an advisory, the FDA said it has verified through post-marketing surveillance that the AideLai Disposable Face Mask is not notified and no corresponding Product Notification Certificate has been issued.
Pursuant to 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 is prohibited.
Since this unnotified medical device product has not gone through evaluation process of the agency, the FDA said it cannot assure its quality and safety.
It then warned all concerned establishments not to distribute, advertise, or sell the said product until the Product Notification Certificate is issued, "otherwise regulatory actions and sanctions shall be strictly pursued."
"Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of CMDN-xxx," it said.
All law enforcement agencies and local government units were requested to ensure that the product is not sold or made available in the market.
The Bureau of Customs was also urged to restrain the entry of the unnotified product. (PR)