Regulatory

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Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2024-08-28 2024-08-26

Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN

Notice of the National Medical Products Administration's Device Review Center on Issuing the Recommended Clinical Evaluation Pathways for Medical Device Classification Catalogue Related Products (2024 Supplement) (No. 11 of 2024)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第11号 Clinical Evaluation 2024-03-18 2024-03-15

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN

Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2023年第33号 Clinical Evaluation 2023-07-24 2023-07-20

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Technical Review Points for Clinical Trials of Intraperitoneal Endoscopic Surgery System (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230424-f2 Clinical Evaluation 2023-04-24 2023-04-24

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Review Key Points Medical Device

Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Classification Catalogue of Medical Devices (No. 30, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第30号 Clinical Evaluation 2022-07-14 2022-07-14

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device

Notice on Publicly Soliciting Opinions on the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220705 Clinical Evaluation 2022-07-05 2022-07-05

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD

Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 02, 03, 05, 06, 16, 18, and 20 of the Classification Catalogue of Medical Devices (No. 24, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第24号 Clinical Evaluation 2022-06-16 2022-06-16

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device

Notice on Issuing Clinical Evaluation Recommended Pathways for Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of the Classification Catalogue of Medical Devices (No. 20, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第20号 Clinical Evaluation 2022-05-19 2022-05-19

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device

Notice on Issuing the Communication and Exchange Procedure for Clinical Real World Data Application Pilot Varieties of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial) (No. 16, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第16号 Clinical Evaluation 2022-04-22 2022-04-18

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device

Recommended clinical evaluation paths for products related to "12 active implantable devices" and "13 passive implantable devices" in the subcategory of the Classification Catalogue of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220406 Clinical Evaluation 2022-04-06 2022-04-06

Status Issued By Level of Legal Effect Product Category Obsolete CMDE/Center for … Work Documents Medical Device

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Notice of the National Medical Products Administration's Device Review Center on Issuing the Recommended Clinical Evaluation Pathways for Medical Device Classification Catalogue Related Products (2024 Supplement) (No. 11 of 2024)

Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023)

Technical Review Points for Clinical Trials of Intraperitoneal Endoscopic Surgery System (Draft for Comments)

Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Classification Catalogue of Medical Devices (No. 30, 2022)

Notice on Publicly Soliciting Opinions on the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials

Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 02, 03, 05, 06, 16, 18, and 20 of the Classification Catalogue of Medical Devices (No. 24, 2022)

Notice on Issuing Clinical Evaluation Recommended Pathways for Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of the Classification Catalogue of Medical Devices (No. 20, 2022)

Notice on Issuing the Communication and Exchange Procedure for Clinical Real World Data Application Pilot Varieties of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial) (No. 16, 2022)

Recommended clinical evaluation paths for products related to "12 active implantable devices" and "13 passive implantable devices" in the subcategory of the Classification Catalogue of Medical Devices