Artixio

End to End Regulatory Partner in China

Navigating NMPA Requirements from Strategy to Post-Market Success

There are numerous opportunities in China for life sciences companies because of its growing healthcare needs. China offers market size of approx. USD 180 billion in pharmaceuticals, USD 96 billion in medical devices, and an emerging cosmetics and nutraceuticals market, making the country destination for companies seeking growth. However, to enter the Chinese market it is necessary to have a thorough understanding of the evolving regulatory landscape governed by National Medical Products Administration (NMPA).
Artixio’s team has decades of experience in providing comprehensive regulatory solutions- from market strategy to product registration and lifecycle maintenance.

Regulatory Authorities in China

The NMPA is the main regulatory body for pharmaceuticals, medical devices, and cosmetics in China. The key bodies within NMPA that regulate various lifesciences products include the National Institutes for Food and Drug Control (NIFDC) and the Centre for Drug Evaluation (CDE). These bodies are directly involved in clinical trial applications and drug registration approvals. Additionally, the Centre for Medical Device Evaluation (CMDE) is responsible for evaluating medical devices.

Pre-Registration

Registration services

Post-Registration

Our Services

Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access

Why Artixio?

Successful Approvals and Ongoing Product Lifecycle Maintenance for 250+ Products in China
Strong Regional Expertise, Experts with 15-35 years of experience
End-to-End Partner from Concept to Market & Post Market
Proven Experience in Navigating through Complex, often Ambiguous Regulations
ISO 9001:2015 quality standards governed services.
Client focused, flexible services and solutions.
Flexible Business Model including project based, managed services and FTE staffing model.
Hybrid-Local-Centralized Support across Regulatory functions.

Industries We Serve in the China

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

FAQs

Do you provide services for local agent in China ?
Yes, Artixio can act as your local agent/ represent your organization to NMPA, managing communication, audit support, response to queries and coordinate submission/post submission activities.
We support post approval activities such as change/variations management, CMC change management, artwork and labelling modifications, advertisement and promotional material review, product renewals, ongoing regulatory intelligence and monitoring.
We support companies with the development and implementation of Quality Management System, trainings, conduct mock audits, vendor audits as per China GMP, ISO 13485, or CSAR requirements.

We help identify and qualify importers/distributors, ensure regulatory compliance of supply chain partners, and manage documentation and contracts needed for GACC clearance and ongoing distribution in China.

Our Global Reach: Serving Life
Sciences Clients Worldwide

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

Insights from Artixio - Tips & Articles

In Vitro Diagnostics: Meaning, Types And Benefits

In Vitro Diagnostics: Meaning,

The term “in vitro” is a Latin word that means “in glass”. Thus, from...

June 20, 2025
IVD Medical Devices Registration & Approval In India

IVD Medical Devices Registration

The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...

June 17, 2025
Pharma Manufacturing Booms in Hidalgo, Mexico

Pharma Manufacturing Booms in

Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...

June 18, 2025