FDA COMPLIANCE MADE EASY
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 28 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.