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

Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f7 Pre-Market 2024-01-03 2024-01-02

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

Notice on Publicly Soliciting Opinions on the Guiding Principles for Writing Medical Device Instructions

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231108 Pre-Market 2023-11-08 2023-11-07

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

Notice of the Comprehensive Department of the National Medical Products Administration on Matters Related to Changes in the Instruction Manual of Some In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注函〔2023〕349号 Pre-Market 2023-07-07 2023-06-28

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

Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised Draft for Comments in 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f5 Pre-Market 2022-11-01 2022-11-01

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

Announcement of the State Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration on Doing a Good Job in the Second Batch of Implementing Unique Identification of Medical Devices (No. 114 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第114号 Pre-Market 2021-09-17 2022-06-01

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

Guidelines for updating and technical review of tumor associated diagnostic reagent manuals based on similar therapeutic drugs

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f1 Pre-Market 2021-04-15 2021-04-07

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

Announcement of the National Medical Products Administration on Further Standardizing the Instructions for Medical Ultrasound Couplants and Other Related Content

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第143号 Pre-Market 2021-01-05 2020-12-25

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

Notice on Matters Related to Submitting Unique Identification of Medical Devices in the eRPS System

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第26号 Pre-Market 2020-12-29 2020-12-29

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

Notice of the National Medical Products Administration on Issuing the Guidelines for Writing Instructions for Hard Breathable Contact Lenses for Corneal Sculpture (Revised in 2020)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第47号 Pre-Market 2020-07-06 2020-07-01

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

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