Regulatory Affairs Consultant in China
Artixio provides comprehensive regulatory affairs services in China, supporting all life sciences industries. We help our clients achieve regulatory approval and streamline market entry, with a focus on compliance at every stage.

Services We Offer
Regulatory Affairs Solutions in China
At Artixio, our strategy for regulatory affairs in China with a strong understanding of local requirements and industry expectations. Our team works closely with the local authorities, stays upto date on the changing regulations, and offers clear, reliable support for your product across every stage.
Artixio’s expert team manages the entire regulatory process—from product approval and clinical trials to market entry for pharmaceuticals to medical devices and cosmetics. We support your product at every stage while meeting all required standards for a successful launch in the Chinese market.
National Medical Products Administration (NMPA) regulatory authority is responsible for regulating the pharmaceuticals, medical devices and cosmetics products in China. It handles product registration, clinical trials, and market authorization. State Administration for Market Regulation (SAMR) oversees approvals for food and dietary supplements, while Ministry of Agriculture (MOA) manages veterinary product regulations. Artixio offers consulting services for regulatory affairs in China to support companies through each step of the registration and approval process.
Regulatory Affairs Process In China

The registration application must include the below mentioned information: –
Product Classification & Feasibility Check
Determine the correct classification (e.g., drug, medical device, IVD, cosmetic)
Assess if the product meets China-specific requirements
Local Agent Appointment
- Designate a China-based legal representative or marketing authorization holder (MAH)
- Required for foreign companies to interact with NMPA (National Medical Products Administration)
Dossier Preparation
- Compile technical documents per NMPA guidelines
- Include administrative, quality, preclinical, clinical, and labeling documentation
- Must be in Chinese (translation required)
- Submit application through the appropriate channel (drug, device, etc.)
On-Site Inspection (if required)
- GMP inspection or Quality Management System audit for drugs and high-risk devices
- May involve foreign manufacturing sites
Why Artixio?
- Industry-recognized, award-winning regulatory expertise
- Proven success in 1000+ product licenses across sectors
- In-house experts with 15-30+ years of experience
- End-to-end support, from product concept to market launch
- Regulatory intelligence-driven, helping you stay ahead
- Focused on quality and customer satisfaction (ISO 9001:2015)
FAQs
What is required for foreign companies seeking regulatory approval in China?
How do I stay updated with regulatory changes in China?
How can Artixio help with regulatory approvals in China?
What are the challenges foreign companies face with regulatory compliance in China?
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Regulatory Affairs Across Multiple Countries

India

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