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About Us

Company profile

PureFDA, a leading medical device CRO with SaaS + Data service, specializing in regulatory compliance consulting on medical device and IVD. Our service networks cover regulatory compliance business in more than 19 countries and regions, including China, the United States, European Union, the United Kingdom, Australia, Brazil, Canada, Colombia, Korea, Thailand, Indonesia, Costa Rica, India, Israel, Japan, Malaysia, Mexico, Saudi Arabia, Singapore.

With a world-class professional team who possesses the requisite expertise in regulatory compliance, clinical trials, and market access, we can provide one-stop solutions to help you with medical devices, in-vitro diagnostics, AI medical software, etc.

Our capabilities:

● Access to 100+ countries’ market

● 1,000+ successful cases of overseas registration and certification

● Database covering 600,000+ global distributors, 1,000,000+ global clinical trials and 3,000,000+ global registration of medical devices.

We endeavor to help medical device and IVD companies enter the international market smoothly with our comprehensive solutions ranging from marketing strategy to regulatory compliance.

● Successful cases

As a global consulting firm focusing on medical device market access, our consulting services span over multiple countries, bridge clinical and commercial aspects, and cover the entire industry value chain. Our professional registration team provides full ranges of services from pre-submission evaluation to follow-up consultation for medical devices and in vitro diagnostic reagents. We have assisted many Chinese manufacturers with successful operations in the United States, Europe, Latin American countries and so on. The following are some typical cases:

☆ In the United States:

PureFDA helped Changsha Renji Medical Equipment Co., Ltd and Jinan Babio Biotechnology Co., Lt obtain FDA VTM white list.

☆ In Europe:

PureFDA helped Sansure Biotech Inc obtain 3 CE 2934 List A certificates for their Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit, Hepatitis C Virus DNA Quantitative Fluorescence Diagnostic Kit, and Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit.

PureFDA helped Shenzhen New Industries Biomedical Engineering Co., Ltd obtain 10 CE 2934 List A certificates for their Anti-HBs (CLIA), Anti-HBs (CLIA) Controls, HBeAg (CLIA), HBeAg (CLIA) Controls, Anti-HBc IgM (CLIA), Anti-HBc IgM (CLIA) Controls, Anti-HBe (CLIA), Anti-HBe (CLIA) Controls, Anti-HBc (CLIA), Anti-HBc (CLIA) Controls.

PureFDA helped Jiangsu iiLO Biotechnology Co., Ltd and other companies obtain CE 2934 certificates for their covid-19 antigen self-test reagents.

PureFDA helped BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC and other companies obtain CE 1434 certificates for their covid-19 antigen self-test reagents.

PureFDA helped INTCO MEDICAL TECHNOLOGY CO., LTD, Shanghai Huayuan Anhui Jinhui Pharmaceutical Co., Ltd and Genrui Biotech Inc obtain HSC common list.

PureFDA helped Jinan Babio Biotechnology Co., Ltd and Zhuhai Lituo Biotechnology Co., Ltd obtain French antigen self-test white list.

☆ In Latin American countries:

PureFDA helped an Chinese anonymous company obtain Colombian product registration certificate.

☆ More successful cases please reach out to our staff.

PureID is committed to empowering medical innovation with new generations of technology based on our expertise in computer technology and big data. We strive to establish a standardized and digitalized system for helping medical devices going global and contribute to the digitalization for the Chinese medical device industry.

Core Values:
Everything we do at PureID is guided by our core values:
●Continuous Learning, 

Social Responsibility:
We live the commitment to shaping the industry and inspiring and engaging in corporate social responsibility fulfillment and public welfare projects. As a contributor to the medical industry, we work with global medical professionals and public interest groups for a better world.