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2026 China NMPA Bluebook is here:
The NMPA, together with National Health Commission and National Healthcare Security Administration, issued the “Advancing UDI Implementation for Subsequent Device Categories” and “UDI Implementation under
The NMPA Center for Medical Device Evaluation (CMDE) issued the “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on March 13, 2026. This initiative
The NMPA approved Shanghai Lixiao’s thermal vapor therapy equipment and the single-use prostate thermal vapor therapy device on February 28, 2026. The thermal vapor therapy
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in March 2026. These updates are presented by China
In 2025, polydeoxyribonucleotide (PDRN) has rapidly emerged as one of the most closely watched bioactive materials in the global skincare and medical aesthetics industry. Across
The National Institutes for Food and Drug Control of NMPA released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and
NMPA published the “Guideline for Registration of Mobile Medical Devices” on May 7, 2025, replacing the 2017 version. This updated guideline is to facilitate manufacturers
China has applied provisional import tariff rates lower than the most-favored-nation rates on 935 items starting from January 1, 2026, the Customs Tariff Commission of
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in February 2026. These updates are presented by China
The Guangdong Provincial Medical Products Administration and the Guangdong Provincial Health Commission issued the “Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, also referred to as the “Specification for Medical Device Production.”
The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to