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Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2023. These updates are presented by China Med Device, LLC, your partner
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2023. These updates are presented by China Med Device, LLC, your partner
Here’s the latest China regulatory and clinical affairs China NMPA News March 2022 for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner
The NMPA released the “Guideline for Medical Device Product Technical Requirements (PTRs)” on February 9, 2022, directing manufacturers on preparing one of the most important documents submitting to NMPA. What
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in January 2022. These updates are presented by China Med Device, LLC, your partner
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in December 2021. These updates are presented by China Med Device, LLC, your partner in
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that,
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020. Clinical data generated outside
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros for November 2021. These updates are presented by China Med Device, LLC, your partner in
The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example names for 31 medical devices.
The NMPA granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan Medtech: Biological Hernia Repair Patch
The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application and change application. The document
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