On September 24, 2013, FDA passed the Final Rule for Unique Device Identifiers (UDI). With some exceptions, the regulation mandates that all medical devices must bear a UDI, which must be issued by FDA or an FDA-accredited issuing agency. FDA or the accredited...
Did you know? If your medical device or drug facility is not registered (or renewed) by December 31, 2013, you may not be able to import products to the United States. The U.S. FDA requires any facility that handles an FDA-regulated good to register. Members of...
Rick Quinn, Partner at Maryland-based international FDA consulting firm FDAImports.com, will be attending and presenting at Mindanao Exporters Congress. The show will be held at the SMX Convention Center of the SM Lanang Premier, in Davao City, Philippines, from...
At the American Association of Exporters and Importers’ recent seminar called “Partnering with OGAs on Risk Management and Globalization,” attendees discussed FDASIA, the U.S.-E.U. Mutual Recognition Agreement, and Good Importer Practices – all things one would expect...
Ben England and Olivia Zuniga of FDAImports.com, an international FDA consulting firm, had a fantastic experience attending and presenting at IFEX Philippines. During the exhibition, Mr. England presented two expert trainings; on the first day, he spoke to industry...
FDAImports.com has opened a new expansion office in Manila, Philippines. Manila is strategically located to allow FDAImports.com to handle client needs in the South Pacific – Malaysia, Indonesia, Thailand, Vietnam, and more. The United States is one of the...
Rick Quinn, Principal at FDAImports.com, and Shelly Li, Regulatory Specialist of ExportToUsa.com.cn, traveled to China to visit companies listed on FDA Import Alert in March. The team intended to increase Chinese companies’ awareness and understanding of FDA...
FDAImports.com announced recently that it would be presenting a webinar on April 15 for companies and trade professionals in the food, drug, cosmetic, homeopathic, dietary supplement, and medical and radiological device industries. The webinar, which is called...
How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes? $500? $750? What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making...
International FDA consulting firm, FDAImports.com, continues to expand its team of regulatory advisors and staff, adding two new members to its growing Maryland headquarters. Thomas Knott, Senior Regulatory Advisor Mr. Knott brings over 30 years of experience and...
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