Medical Devices

Breaking news – NMPA restarts overseas factory inspections in earnest
Breaking news – NMPA restarts overseas factory inspections in earnest

NMPA overseas factory inspection results have seen at least three medical device manufacturers notified by the authorities this week alone...

March 1, 2024
Breaking news – NMPA restarts overseas factory inspections in earnest
GB9706 series standards status update
GB9706 series standards status update

GB9706 series standards status update has been released by the National Institutes for Food and Drug Control (NIFDC) on January 19, 2024.

February 29, 2024
GB9706 series standards status update
China medical device industry standards: Newly released and revised standards in February 2024 for implementation
China medical device industry standards: Newly released and revised standards in February 2024 for implementation

China medical device industry standards have a new list released on February 19, 2024, with some being revised for implementation as well.

February 29, 2024
China medical device industry standards: Newly released and revised standards in February 2024 for implementation
China Greater Bay Area demand for medical products surges by 154% in 2023
China Greater Bay Area demand for medical products surges by 154% in 2023

China Greater Bay Area demand for medical products surges as Guangzhou customs supervised over 101 batches of imported products in 2023...

January 16, 2026
China Greater Bay Area demand for medical products surges by 154% in 2023
China medical device standards 2023 annual report issued
China medical device standards 2023 annual report issued

China’s NMPA has released its annual report for medical device standards management for 2023. There are now 1,974 standards.

March 1, 2024
China medical device standards 2023 annual report issued
China medical device registrations 2023 annual report issued
China medical device registrations 2023 annual report issued

China medical device registrations 2023 annual report has been issued by the NMPA.

March 13, 2026
China medical device registrations 2023 annual report issued
Cisema presenting at FORUM Institut: Medical Device in China - Market Potential and Product Approval
Cisema presenting at FORUM Institut: Medical Device in China - Market Potential and Product Approval

Cisema will give a presentation with Forum to talk about the medical device Market Potential and Product Approval in China on June 4-5, 2024.

February 21, 2024
Cisema presenting at FORUM Institut: Medical Device in China - Market Potential and Product Approval
Webinar: Medical Device Pathways to Market for China
Webinar: Medical Device Pathways to Market for China

Webinar: Medical Device Pathways to Market for China on February 15, 2024. This will help you understand the right way for your products.

March 26, 2024
Webinar: Medical Device Pathways to Market for China
China real-world evidence research design for medical devices guideline has been released
China real-world evidence research design for medical devices guideline has been released

Real-world evidence research design and statistical analyses guideline has been released by China’s Center for Medical Device Evaluation.

February 9, 2024
China real-world evidence research design for medical devices guideline has been released
China IVD IFU Guidelines released
China IVD IFU Guidelines released

China’s NMPA has released revised guidelines on preparing IVD IFU (Instructions for Use) by CMDE on January 3, 2024.

March 13, 2026
China IVD IFU Guidelines released
China Medical Device Standards Catalogue 2024 update has been released
China Medical Device Standards Catalogue 2024 update has been released

China’s NMPA has released an update of the Medical Device Standards Catalogue on January 15, 2024. It includes 1974 medical device standards.

February 1, 2024
China Medical Device Standards Catalogue 2024 update has been released
China medical device business quality management standards issued by NMPA
China medical device business quality management standards issued by NMPA

China’s NMPA has issued revised medical device business standards which will come into effect on July 1, 2024.

January 3, 2024
China medical device business quality management standards issued by NMPA

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