FDA to Refuse Admission of Devices from Chinese Company for MDR Violations, Unapproved Marketing
A Chinese beauty product manufacturer’s devices will be subject to refusal at the border for failure to register their product with FDA and violations of Medical Device Reporting regulations, said the Food and Drug Administration in a warning letter. According…
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
to FDA, Nanhai Meishida Beauty Equipment did not indicate that it had trained employees in MDR procedures. It also markets a “13 in 1 Beauty Instrument” with a “high-frequency function” that induces “sterilization and evaporation,” as well as “hyperemization,” among other things. The company didn’t get permission from FDA in the form of premarket approval or an investigational device exemption, FDA said.