Amidst the heightened scrutiny under the updated MoCRA FDA regulations, many companies are feeling the pressure. Here's the success story of global enterprise S, which partnered with Provision to establish a clear, strategic response and overcome the complex regulatory hurdle. This wasn't just about procedure; it was about a sincere partnership. The Challenge: A Global Company Confronts Unfamiliar Regulations Since the enforcement of the Modernization of Cosmetics Regulation

Companies looking to enter the U.S. cosmetics market should pay close attention to the latest news from the FDA regarding MoCRA...

Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...

On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...

What the End of the “De Minimis” Rule Means for FDA-Regulated Imports As of July 2025, the U.S. FDA has officially eliminated the...

March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...

Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...

February 07, 2025 The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era of regulatory oversight for the...

February 6, 2025 Common Mistakes to Avoid as an FDA Initial Importer When importing medical devices into the United States, manufacturers...

February 5, 2025 Risks of Not Having an FDA Initial Importer When importing medical devices into the United States, failing to designate...

February 4, 2025 Responsibilities of an FDA Initial Importer When importing medical devices into the United States, manufacturers must...

February 3, 2025 Why Choosing the Right Initial Importer Matters Selecting the right FDA Initial Importer is a critical decision for...

January 31, 2025 Understanding the Role of an FDA Initial Importer For foreign medical device manufacturers  looking to enter the U.S....

January 30, 2025 Keyword Phrase:   FDA Initial Importer Requirements Understanding the Role of an FDA Initial Importer If you manufacture...

January 29, 2025 The FDA strives to take decisive steps to help consumers make healthier food choices by proposing a standardized...

January 10, 2025 Importing medical devices into the United States is a complex process that requires strict adherence to regulations set...

January 10, 2025 The way we define “healthy” in the United States is undergoing a significant transformation, thanks to updated...

December 17, 2024 In the fast-paced world of food importation, delays at the border can mean missed opportunities and wasted resources....

December 12, 2024 The U.S. Food and Drug Administration (FDA) has released updated guidance for the cosmetics industry, focusing on the...

December 09, 2024 When it comes to navigating FDA regulations, achieving 510(k) clearance can feel like running a marathon. The process...