INSIGHTS

Regulatory Affairs

Regulatory Analysis

China’s New Medical Devices Administration Law: A Comprehensive Regulatory Framework

China's proposed Medical Devices Administration Law heralds a new era in medical device regulation, promising enhanced safety, accelerated innovation, and improved market access.

Series, Regulatory Text

NMPA Guidelines for Submission of Cosmetics Safety Assessment China, Part I

Introduction of a comprehensive framework for evaluating and documenting the safety of cosmetic products in China.

Regulatory Analysis

Navigating China’s Drug Instruction and Labelling Regulations

Explore the details of China's drug instruction and labeling requirements to ensure regulatory compliance and optimize patient safety in the world's second-largest pharmaceutical market.

Regulatory Analysis

China’s Medical Device Labeling Regulations: Implications for Foreign Brands

This article examines the current labeling requirements for medical devices in China, their impact on foreign brands, and the critical importance of local regulatory expertise.

Regulatory Analysis, Industry Insight

Navigating the Maze

Dive deep into China's OTC drug registration process, exploring overseas clinical trial acceptance, first-in-market opportunities, and local testing requirements. Gain crucial insights for successful market entry and regulatory compliance in this comprehensive guide.

Industry Insight

From Control to Innovation

The Transformation of China's Drug Administration Law. China’s pharmaceutical regulatory landscape is undergoing a dramatic shift, with far-reaching implications for both domestic and international players.

Regulatory Analysis, Industry Insight

Navigating China’s Evolving Drug Registration Landscape: A Comprehensive Guide for Regulatory Professionals

Dive deep into China’s drug registration process, exploring overseas clinical trial acceptance, first-in-market opportunities, and local testing requirements.

Since 2012, Knudsen & CRC has been at the forefront of supporting international brands in overcoming regulatory barriers in highly regulated markets. Our expertise spans across Cosmetics, Skincare, Food & Beverages, Nutritional Supplements, Functional Health Foods, and more. At Knudsen & CRC, we go beyond traditional compliance, we’re shaping a world where international brands thrive in highly regulated markets. Our diverse team of global experts doesn’t just navigate complex regulations—we transform them into opportunities for growth.
We are pioneering change, fostering collaboration, and delivering transparency. Together, we’re not just meeting standards; we’re setting them.

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