INSIGHTS

Medical Regulatory Team

Regulatory Analysis

China’s Regulatory Framework for Disinfection Products

Explore the booming growth of China's disinfection product industry and uncover the essential regulations shaping its compliance and market success.

Market Guide

Understanding Regulatory Compliance for Disinfections in China: A Comprehensive Guide

This piece gets into everything in China's disinfection regulations, from product classification to licensing requirements and quality control standards.

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.

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

Compliance Guidelines for Disinfection Product Manufacturers in China

A comprehensive guide for foreign manufacturers entering China's disinfection product market, ensuring compliance from pre-market requirements to post-market responsibilities.

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.

Regulatory Text

Administrative Measures for Drug Registration

Outline comprehensive regulations for drug research, registration, and market authorization, ensuring safety, efficacy, and quality control across TCM, chemical drugs, and biological products.

Regulatory Text

Specification for Hygienic Supervision of Disinfection Products

Outline comprehensive regulations for disinfectant manufacturers, importers, and users, emphasizing strict hygiene supervision to safeguard public health in the medical sector.

Regulatory Text

Administrative Measures on Disinfection

Outline comprehensive regulations for disinfection management, product standards, and service providers, aiming to prevent infectious diseases and protect public health.

Regulatory Text

Notice of the National Health and Family Planning Commission on Regulations on Hygiene and Safety Evaluation of Disinfection Products

A comprehensive framework for evaluating, classifying, and managing disinfection products.

Regulatory Text

Management Practice for Labeling and Instructions of Disinfection Products

Provide comprehensive guidelines for labelling of disinfectants, ensuring product safety and efficacy through stringent regulatory oversight and standardized information disclosure

Regulatory Text

Drug Administration Law of the People’s Republic of China

Provide a comprehensive framework for drug development, production, and distribution, emphasizing safety, efficacy, and accessibility while promoting innovation in both modern and TCM sectors.

Regulatory Text

Regulations on the Administration of Drug Instructions and Labels

Provide regulatory standards for drug information disclosure, ensuring clear, accurate, and scientifically-backed instructions and labeling.

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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