From 1 January to 31 December 2023, China’s NMPA accepted a total of 13,260 applications for the first registration, renewal of registration and change of registration of medical devices in accordance with its duties, an increase of 25.4% compared with 2022.

From 2019 to 2022, the market experienced substantial growth, surging from $124.7 million to $1,155.6 million at an impressive Compound Annual Growth Rate (CAGR) of 110.1%. Projections indicate a continued expansion, reaching an estimated $75,568.8 million by 2030, albeit with a moderated CAGR of 39.2%, signaling a deceleration in market growth.

Chinese molecular diagnostic firm Dinfectome said on Monday that its DIFSeq-200 sequencer has obtained approval from the Chinese National Medical Products Administration (NMPA).

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

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.

As the demand for the mass spectrometry market in China has rapidly increased, major domestic and international mass spectrometer manufacturers have accelerated their product registration efforts. In recent years, a variety of different types of mass spectrometry instruments have obtained NMPA certificates.

MGI Tech said last week that its DNBSeq-G99 sequencer has been approved as a medical device by China's National Medical Products Administration (NMPA).

On 5 July 2023, National Medical Products Administration announced the imported Class I medical device product in June 2023. A total of 145 product information, including 7 products in the IVD industry, were finally released.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

Helio Genomics said Thursday that its sister company, Laboratory for Advanced Medicine & Health Group (LAMH), has received approval from the National Medical Products Administration (NMPA) in China for its cell-free DNA-based liver cancer detection test. The assay is the first of its kind to receive this approval.