Regulatory

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2025年第19号 Clinical Evaluation 2025-05-13 2025-05-13

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

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

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

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240731 Clinical Evaluation 2024-07-31 2024-07-30

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 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

Technical guidance principles for product comparison instructions included in the list of medical devices exempt from clinical evaluation

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f5 Clinical Evaluation 2021-09-28 2021-09-18

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

List of Medical Devices Exempted from Clinical Evaluation (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210519-1-f7 Clinical Evaluation 2021-05-19 2021-05-18

Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD

FILTER

Product Life Cycle

Status

Level of Legal Effect

Product Categories

Issuing Organization

Latest Regulations

10 Results

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 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)

Technical guidance principles for product comparison instructions included in the list of medical devices exempt from clinical evaluation

List of Medical Devices Exempted from Clinical Evaluation (Draft for Comments)