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.

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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?

FAQs

What is required for foreign companies seeking regulatory approval in China?

Foreign companies must comply with additional requirements such as appointing local representation, meeting Chinese safety standards, and ensuring that products adhere to local labeling and packaging regulations.

How do I stay updated with regulatory changes in China?

Staying informed on regulatory changes in China requires close monitoring of updates from relevant authorities. Regular communication with local partners and regulatory experts helps ensure compliance with evolving requirements.

How can Artixio help with regulatory approvals in China?

Artixio works closely with local regulatory bodies to guide your product through the approval process. We ensure that all documentation, testing, and compliance requirements are met for a smooth entry into the Chinese market.

What are the challenges foreign companies face with regulatory compliance in China?

Foreign companies often encounter challenges such as language barriers, local representation requirements, and navigating the country’s regulatory processes. Artixio helps manage these challenges by providing local expertise and regulatory guidance.