Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.
For foreign medical device firms, FDA establishment registration and U.S. Agent designation are not optional—they are mandatory requirements for accessing the U.S. market. Errors in either process can lead to shipment delays, import holds, or FDA Import Alerts that disrupt business operations and market access. Drawing on nearly 50 years of regulatory experience and
BEWARE – FDA Inspections in China with 5 day notice mdi recently received an email from one of our clients in China that read: “We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday. Is this normal to be contacted from
mdi Consultants, Inc