Public told not to buy medical device product not registered with FDA

Published May 6, 2018, 7:07 PM

by Francine Ciasico

By Analou De Vera

Health authorities warned health professionals as well as the public against patronizing a medical device product that was found unregistered with the Food and Drug Administration.

FDA logo (Google image) Manila Bulletin
FDA logo (Google image) Manila Bulletin

The FDA in its advisory 2018-161, that the product: Medison Blood Lancets has been found unregistered but is available in the market.

“FDA postmarketing surveillance (PMS) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration,” the FDA stated.

“Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public,” the agency added.

The FDA advised the public not to purchase the said product and always check before buying if a medical device is registered with the agency “by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.”

“All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA said.

 
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