
Four Documents in Support of Order 739 Released
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, Order 739. Four supporting regulations have been
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, Order 739. Four supporting regulations have been
NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedbacks need to be submitted by April 17, 2021. It is responding to the “2021 Medical
NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before. “Medical device manufacturers should take the initiative to collect all
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019. Medical device master file in China is a technical document
New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released. It was adopted by the China State
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros in February 2021. These updates are presented by China Med Device, LLC, your partner in
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros for January 2021. These updates are presented by China Med Device, LLC, your partner in
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On March 16, 2021 the amendment
NMPA granted nine manufacturers innovation approval and priority review status, including four overseas ones. The List Oncology Mevion Medical Systems: Proton Therapy System Biosense Webster (Israel): Magnetic Positioning Multi-channel Pulsed
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway for clinical evaluation, which is
NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing
The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and
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