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QMS/PMS

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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Post-market Periodic Risk Evaluation Report Mandatory For License Holder In China

2022-06-29

As per Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events, NMPA has regulatory requirements for…

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NMPA Enhances Cross-reginal MAH Surveillance

2022-05-30

The implementation of medical device MAH in China is aiming at promoting the reform of medical device review…

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Interpretation Of Relevant Regulatory Documents And Response Strategies On China National Medical Device Quality Sampling And Inspection Work In 2022

2022-03-23

In recent years, with the national policy and the continuous adjustment and optimization of the industrial structure around…

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NMPA Strengthening The Supervision And Management Of Medical Device Registration

2022-02-27

In 2021, NMPA continues to strengthen the supervision and management of medical device registration. Class I filing surveillance…

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