Product Registration Services in China for Life Sciences

Expert Guidance and Regulatory Support for Product Registration in China Across All Life Sciences Industries.

Services We Offer

China Product Registration Services for Life Sciences

At Artixio, we simplify the product registration process in China, helping life sciences companies meet the country’s regulatory requirements.

Artixio supports you through every step of the product registration process in China, from initial document submission to final approval. Our expertise in local regulations ensures that your product meets all required standards, allowing for effective market entry and access to Chinese consumers.

Regulatory Authority in China

The National Medical Products Administration (NMPA), formerly known as the CFDA (China Food and Drug Administration), is the primary regulatory body responsible for overseeing the approval of drugs, medical devices, and other healthcare products in China.

Registration Process in China

Market Research and Classification
Prepare Regulatory Dossier
Initiate contact with the NMPA and follow their process for product review
Conduct clinical trials in China as per NMPA’s guidelines
Once all requirements are met, NMPA will grant approval for market release.
Maintain post-market surveillance to comply with Chinese regulations

Choose Artixio for Product Registration in China

Expert Knowledge of NMPA Guidelines
From initial consultation to final product approval, Artixio supports every step of the registration process.
Customized strategies for your products based on their classification in Taiwan, optimizing timelines and reducing costs.
A local team in Taiwan with in-depth knowledge of the specific product registration requirements

FAQs

Can Artixio assist with the resubmission process if a product is rejected which is submitted by a client?

If a product is rejected, Artixio helps assess the reasons for rejection and offers support in revising and resubmitting the application, ensuring that all issues are addressed before resubmission.

What do I need to know about product registration in Taiwan?

To get your product registered in Taiwan, you’ll need to prepare several documents, including product specifications and any required test results. Our team makes the process straightforward by handling all the details for you.

Is local testing required for product registration in Taiwan?

In some cases, local testing is required to meet Taiwan’s safety standards. We coordinate this testing for you, making sure everything is in line before submission.