Canadian, Mexican, Brazilian, European and Asian regulations are not similar or equivalent. Why would you take a chance?
Whereas the United States has always relied on a strictly centralized process through one agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 27 member countries of the European Union, while preserving national “autonomy.”
The biotech industry asserts that the U.S. drugs and or devices approval is much slower than in Europe, and that European patients enjoy earlier access to innovative drugs and technology over U.S. patients. Furthermore, product liability lawsuits are less common in Europe than in the United States. That explains why initial approval of U.S. company-backed devices is increasingly being sought in the E.U. before any application is submitted to the FDA in the United States.
However, CE Marking is not FDA Approval or Clearance. Facility or Establishment Registration and product listing are require to expand your market.
For Domestic and Foreign Companies
FDA has determined that the current evidence supports a qualified health claim concerning the relationship between cocoa flavanols in high flavanol cocoa powder and reduced risk of cardiovascular disease (CVD) for conventional foods.
U.S. FDA’s laboratory testing found that some honey-based products samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction.
Περισσότερες από 1336 ελληνικές εταιρείες τροφίμων είναι εγγεγραμμένες στον FDA των Ηνωμένων Πολιτειών.
Más de 4873 empresas alimentarias españolas están registradas ante la FDA de Estados Unidos.
4473개 이상의 한국 식품 회사가 미국 FDA에 등록되어 있습니다.
Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.