의료기기 이야기

This month, the U.S. Food and Drug Administration (FDA), finalized guidance requiring manufacturers to notify them of discontinuations or meaningful interruptions in manufacturing for many devices during or in advance of a public health emergency (PHE). This relatively new authority was established through the 2020 CARES Act and amended by the 2023 Omnibus Consolidated Appropriations Act, alteri..

The regulator in Mexico, COFEPRIS, released a 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), which inserted regulatory requirements for Software as a Medical Device (SaMD). Software was included officially in the definition of medical devices and rule 16 was added to Appendix II to classify software according to risk (Class I, II, or III..

We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical de..