Li Li, commissioner of China's National Medical Products Administration (NMPA), led a delegation to Vietnam and Thailand from 11 to 15 November to enhance bilateral collaboration in pharmaceutical regulation. During the visit, Li signed memorandums of understanding (MoUs) with health authorities in both countries.

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.

In 2020, NMPA approved 18 types of class III molecular diagnostic instruments, and the provincial medical product administration approved 11 types of class II molecular diagnostic instruments, a total of 29.

Burning Rock Biotech and drugmaker Dizal said Thursday that they have received approval from China's National Medical Products Administration (NMPA) for a next-generation sequencing-based companion diagnostic for the lung cancer drug sunvozertinib.

The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administration (hereinafter referred to as NMPA).

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

In April, the recent release of the 2024 medical device classification encompasses 223 results, including 93 products related to In Vitro Diagnostics (IVD). Among these, 27 IVD-related products are suggested for Class III medical device management, 45 for Class II, and 14 for Class I.

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

C-luminary Biotech was founded in 2018 and is headquartered in Chengdu, China, with a research and development center in Suzhou and industrial platforms in Sichuan and Hunan, is a professional enterprise engaged in the research, development, production, and sale of in vitro diagnostic products.

In 2023, a total of 12,213 first registrations, renewals of registrations and changes of registrations of medical devices were approved by NMPA, representing an increase of 2.3% in the total number of registration approvals compared with 2022.