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2026 China NMPA Bluebook is here:
NMPA Center for Medical Device Standardization Administration Issued the draft national standard “Post-Market Surveillance for Medical Device Manufacturers” on July 19, 2024, for feedback. Feedback needs to be submitted by
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted by August 30, 2024. Implementing
To respond to the emerging trend of adopting software in health care, China has told its regulators what to look for when approving software and how evaluating its quality and
On August 28, 2024, the NMPA released the “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment).” Feedback needs to be submitted
The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. It revises the classification processes for devices, combination products and newly developed medical devices,
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
NMPA published 12 medical devices guidelines on August 12, 2024. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device Guidelines The guidelines are prepared by
NMPA published the final document of “Guideline for On-Site Inspection of Medical Device Operation Quality Management” on July 30, 2024. The draft was issued on June 27, 2024, for feedback.
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
The NMPA issued an inspection result on July 19, 2023, identifying the size error in product technical requirement (PTR). NMPA organized a remote inspection of SAMO S.p.A, an Italian orthopedic
PD-L1, a transmembrane protein, binds to PD-1 to transmit inhibitory signals, helping tumor cells evade T-cell attack. Blocking the PD-1/PD-L1 pathway is effective in cancer treatment. PD-L1 expression levels predict
NMPA published the “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings” on July 19, 2024. It green lights the urgent importation and use of