Introduction

Established in 2020, July 31^st, Hypoxia Laboratory SZU (HLSZU) is the collaboration between Shenzhen University General Hospital (SUGH) and Bickler Hypoxia Laboratory (named after Dr. Bickler) of the University of San Francisco, California (UCSF No. 5 ranking hospital in the U.S.). At present, HLSZU is the only standard hypoxia laboratory with test assessment reports well accepted and recognized by health officials worldwide and regulatory bodies including US FDA, CE and NMPA of China.

Bickler Hypoxia Laboratory at the University of California, San Francisco Branch Medical Center has been the world’s leading international famous laboratory for studying the effects of hypoxia on human body for more than 60 years. It is a professional consulting laboratory for ISO standards related to hypoxia. Phillip Bickler, the current head of the laboratory, is a professor in the Department of Anesthesiology at UCSF Medical Center (the second best specialty in the U.S.), the director of the Department of Cerebral Neuroanesthesiology, and the current president of the International Hypoxia Association. In recent years, the laboratory has carried out product R&D and testing for nearly a thousand medical enterprises and companies around the world, with participating volunteers exceeding ten thousand, making it the first choice for the certification and evaluation of oximetry testing equipment of international renowned brands such as Nellcor, Masimo, Nonin, Nihon Kohden etc. The reports generated by the laboratory is regarded as the most authoritative clinical device study reports by FDA and European certification bodies. It is the main reference standard and quality evaluation document for the registration and listing of oximetry monitoring products in countries all over the world.

Shenzhen University General Hospital (SUGH) completed the filing of NMPA Medical Device Clinical Trial Institution (Device Clinical Trial Institution Filing No. 201900064) on April 4^th, 2019, and obtained qualification to carry out clinical testing and data analysis of medical devices. Clinical test reports issued are recognized by the Chinese NMPA and can be used as the evaluation basis for the registration and listing of medical devices. The cooperation between Bickler Hypoxia Laboratory of the U.S and Shenzhen University General Hospital (a GCP certified unit with NMPA filing and approval), is a fundamental condition and basis for its clinical test evaluation report to be recognized by the Chinese NMPA.

During the incubation period of the HLSZU, Bickler (China) Hypoxia Laboratory in the U.S. has provided product registration evaluation services for 137 foreign and 108 domestic medical enterprises involved in the R&D and production of oximetry products.