FDA
The Food and Drug Administration (FDA), the US regulating authority, has updated the information materials dedicated to importing and exporting medical devices. Importing and Exporting: the Basics According to the general rule, the entity involved in the...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published final guidance dedicated to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a voluntary pathway simplify the approach to be...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the procedures associated with the recognition and withdrawals of the FDA-recognized voluntary consensus standards medical device manufacturers may refer to in order to demonstrate conformity...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s medical device regulating authority, has published a guidance document on requirements of shipments clearance at ports of entry. The document is intended to provide additional information on compliance matters...
FDA
The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
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