The Philippines FDA Publishes New Guidance on Medical Device Recalls
The Philippines Food and Drug Administration (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.
A copy of the full FDA Circular 2016-012 is available here.
Contact Asia Actual to register medical devices in the Philippines under the new Circular.