INSIGHTS

Medical

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.

Service

Global Claims Testing Services

We optimize your product's global marketability while adhering to diverse regulatory requirements through expert regulatory insights, tailored testing protocols, and efficient laboratory management.

Service

Global R&D and Product Development

We optimize your cosmetic product development through a China-first compliance strategy, ensuring regulatory compliance and efficacy across major markets worldwide.

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.

Service

M&A Advisory Services for Highly Regulated Industries in China

We provide regulatory assistance through every stage of M&A transactions, from preliminary evaluations and due diligence to post-transaction support.

Service

Medical Device Registration Services in China

We manage the entire NMPA process, from preliminary assessments and documentation to application submission and post-registration support.

Service

Drug Registration Services in China

We streamline your drug registration process through NMPA approval, from preliminary assessments and documentation to application submission and post-registration support.

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.

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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