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QMS/PMS

China NMPA Released Plan For Annual Medical Device Quality Inspections

2024-02-28

As the annual China NMPA medical device quality inspections gear up from March to April, lasting until the…

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Medical Device Quality Alert: NMPA Inspection Results

2023-11-21

The National Medical Products Administration (NMPA) has released findings from its recent quality inspection, revealing that 20 batches…

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NMPA Notice On Unannounced Inspections

2023-11-02

Recently, NMPA conducted unannounced inspections of four enterprises and found the following major deficiencies in their quality management…

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NMPA Suspends Import And Use Of Swedish XVIVO Perfusion System Due To Major Findings From Remote Overseas Inspection

2023-10-27

Recently, the NMPA has announced the suspension of import, distribution, and use of the Swedish XVIVO Perfusion System,…

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China NMPA Releases The Results Of Medical Device Sampling Inspections

2023-08-30

In order to strengthen the supervision and management of medical devices, and ensure that the quality of medical…

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NMPA Suspended The Import, Sales And Use Of ExFuse Bone Graft Of HansBiomed Corp. After Remote QMS Audit

2023-07-17

National Medical Products Administration (NMPA) organized a remote QMS inspection of the ExFuse Bone Graft manufactured by HansBiomed…

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NMPA Notice On The On-Site Inspection Guidelines Of Enterprise Quality Management Specialized In Medical Device Transportation And Storage Services As Appendix For Medical Device Good Supply Practice

2023-06-06

On May 24, 2023, NMPA releases new guidelines aimed at enhancing the supervision and management of medical device…

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NMPA Further Enhancing The Surveillance On Radiofrequency Beauty Devices

2023-05-29

On April 12, the NMPA published Announcement No. 8 of 2023, which outlined the "Guidelines for Registration Review…

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NMPA Onsite Inspection On Manufacturers Or Legal Agent Without Submitting Annual Quality System Self-Inspection Report Since April 2023

2023-04-10

For manufacturers operating medical devices in China, NMPA has issued the deadline for submitting the 2022 Annual Quality…

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China Starts Implementing The Third Batch Of Medical Device UDI

2022-12-16

NMPA issued the Announcement on the implementation of the third batch of Medical Devices UDI (Draft for Comments)…

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NMPA Notice On The Publication Of Guidelines For Quality Management System Audit Of Medical Device Registration

2022-10-23

In order to do a good job of quality management system audit under medical device MAH (Market Authorization Holder) system…

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China Supporting Hong Kong And Macao Medical Device Registrants To Produce Medical Devices In 9 Cities Of The Greater Bay Area

2022-08-04

To promote the reform of the medical device registrant system (Market Authorization Holder, MAH for short) in the…

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