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PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES
Views708 Release time2018/10/11

With FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines government announced intentions to gradually switch to power-free gloves.  A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.

This action comes in follow up to an FDA Advisory from earlier in the year outlining the risk associated with powered gloves.

The Philippines FDA has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.

The Circular provides guidance on how to conduct a recall in the Philippines and criteria for recall triggers. Also included is information on the composition and responsibilities of the Product Recall Committee and Market Authorization Holder.

Other steps toward harmonization are expected early in the new year.


 

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