Rapigen, Inc., an in vitro diagnostics company specializing in rapid diagnostic tests, announced that three of its malaria rapid diagnostic tests (RDTs) — BIOCREDIT Malaria Ag Pf (pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRPII), and BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) — were officially added to the World Health Organization (WHO) Prequalification (PQ) product list on April 14, 2025. With this listing, Rapigen becomes eligible for UN procurement channels and global public health supply programs.

Cepheid today announced that its Xpert® MTB/XDR test has been awarded prequalification status by the World Health Organization (WHO), marking a new milestone in the global fight against tuberculosis (TB). This designation affirms the test's compliance with the WHO's rigorous standards for quality, safety, and performance, and enables procurement through international agencies.

China enacted new measures, effective immediately, targeting the procurement of certain medical devices imported from the European Union in government purchasing programs, according to a notice issued by the Ministry of Finance on Sunday.

The European Commission decided to exclude Chinese companies from EU government purchases of medical devices exceeding €5 million. This measure follows the conclusions of the first investigation under the International Procurement Instrument (IPI), and allows no more than 50% of inputs from China for successful bids.

Presently, the biochemical diagnosis industry is facing fierce competitions in the price, policies, and development models.

In terms of the pharmaceutical macro-political environment, the biomedical industry policies such as medical insurance cost control and target quantity procurement, are gradually implementing.

Anhui Healthcare Security Administration in November issued a notice that a procurement involving 5 product categories and covering 25 provinces starts. The procurement will last 2 years.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

On 28 July, NHSA issued the "Notice on Providing Basic Medical Security for Urban and Rural Residents in 2023 by National Healthcare Security Administration, Ministry of Finance and State Taxation Administration".