Devyser has achieved a significant regulatory milestone with its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.

China has seen a surge of entry from foreigners during the third quarter this year, statistics from the National Immigration Administration showed.

From 20 September to 3 October, 2024, CACLP held a series of five successful online promotional webinars, aimed at fostering international collaboration within the in vitro diagnostics (IVD) industry.

Mr. Eui-Yul Choi, Chairman of Korea In Vitro Diagnostic Medical Device Association, CEO of Boditech Med, led a delegation to visit China Association of In-Vitro Diagnostics (CAIVD), on 26 June 2024.

As of 30 April 2024, there were 82 Chinese IVD listed companies, of which 61 were listed companies with main IVD business (IVD business accounted for more than 50% of the total business), and 21 were listed companies with IVD-related business.

The fully automatic biochemistry analyzer, characterized by high technical content, high accuracy, high precision, high flexibility, and high working efficiency, has become one of the indispensable instruments in the modern clinical laboratory for the increasing testing work.

At the early stage of development of chemiluminescence in China, many manufacturers have gone through a road of breakthrough of unique items in the market, and of course, the expansion of some items has also provided important value to clinical practice.

If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.

Immunoassay is the largest subdivision in in vitro diagnosis and is in rapid develop-ment, in which chemiluminescence has gradually replaced enzyme-linked immuno-sorbent assay as the mainstream immune diagnosis in China.

China's medical device industry has grown at a compound annual growth rate of 10.54% over the past five years and has become the second largest market in the world.