As China and the Malaysian governments deepen their cooperation on mutual recognition of medical device regulatory systems, leading Chinese medical device companies are seizing unprecedented opportunities for international expansion.

Good News ： ZhiGong Bio’s three innovative flagship products have, for the first time, been approved in Malaysia. “ Pass permit ”

As China and the Malaysian governments deepen their cooperation on mutual recognition of medical device regulatory systems, leading Chinese medical device companies are seizing unprecedented opportunities for international expansion. Against this backdrop, in December 2025, Zhigong Bio’s three core instruments—its independently developed ELISA analyzer, flow cytometer, and time-of-flight mass spectrometer—successfully cleared the China–Malaysia medical device approval mutual‑recognition pathway and obtained registration certificates issued by Malaysia’s Medical Device Authority (MDA). This milestone not only marks a landmark achievement for Zhigong Bio in the ASEAN market but also serves as another exemplary model of China and Malaysia working together in the medical device sector to advance jointly and achieve win‑win outcomes.

The three instruments approved this time span the spectrum from routine immunoassays to advanced cell analysis, and further to precision mass spectrometry. The comprehensive solution for certification underscores the Yantai High-tech Zone’s innovative strength in the field of high-end medical device manufacturing. Enzyme-linked immunosorbent assay analyzer As the core instrument of ELISA technology, it features stable assay performance and convenient, efficient operation, and can be flexibly adapted to a wide range of clinical and laboratory testing applications. Flow cytometer Featuring a dual-laser, eight-color configuration, it enables automated cell analysis and sorting, supporting a wide range of clinical and research applications—including sperm analysis, lymphocyte subset characterization, and DNA ploidy assessment—while delivering highly accurate data with excellent reproducibility. Time-of-Flight Mass Spectrometer Based on MALDI-TOF technology, microbial proteins can be precisely identified and their spectra generated through laser ionization and time-of-flight analysis, with a mature and cutting-edge technical workflow.

This successful approval marks a solid step forward in Zhigong Bio’s international expansion, as the company transitions from a reagent supplier to a provider of comprehensive, high-end diagnostic‑instrument solutions. The company plans to establish deep collaborations with Malaysia’s leading healthcare institutions, universities, and distribution partners, supporting the country’s advancement in precision diagnostics and translational medicine through joint development of demonstration laboratories, clinical research initiatives, and systematic training programs.

Looking ahead, Zhigong Bio will continue to leverage the increasingly robust regulatory and industrial cooperation framework between China and ASEAN countries, bringing more innovative, high‑quality IVD solutions to the Southeast Asian market and contributing the strength of Chinese technology enterprises to the building of a community of health for all.