Regulatory

Guidelines for Technical Review of Registration of Group B Streptococcus Nucleic Acid Testing Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f4 Registration & Filing 2021-04-15 2021-04-07

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

Guidelines for Technical Review of Registration of Human Parvovirus B19IgM/IgG Antibody Detection Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f5 Registration & Filing 2021-04-15 2021-04-07

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

Notice of the Comprehensive Department of the State Medical Products Administration on Issuing the Work Procedures for National Medical Device Quality Sampling and Inspection

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2021〕46号 Supervision & Inspection 2021-04-13 2021-04-12

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

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing Inspection Points for Adverse Event Monitoring by Medical Device Registrants

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2021〕43号 Usage 2021-04-09 2021-04-06

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

Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2021-03-18 2021-06-01

Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN

Guidelines for Technical Review of Low Temperature Gas Sterilizer Registration (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f4 Registration & Filing 2021-03-17 2021-03-17

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

Guidelines for Technical Review of Registration of X-ray Imaging Devices for Pediatric Applications (Draft for Solicitation of Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f8 Registration & Filing 2021-03-17 2021-03-17

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

Guidelines for Technical Review of Registration of Anti Mueller's Hormone Assay Reagents (Draft for Solicitation of Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f9 Registration & Filing 2021-03-17 2021-03-17

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

Notice on Receiving Paper Materials for Self Withdrawal of Medical Device Registration Application Projects (No. 4, 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第4号 Registration & Filing 2021-03-17 2021-03-17

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

Announcement of the National Medical Products Administration on Issuing the Medical Device Industry Standard "General Technical Requirements for Oral Collagen Membranes" (No. 39 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第39号 Product Type Testing 2021-03-16 2022-04-01

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

FILTER

Product Life Cycle

Status

Level of Legal Effect

Product Categories

Issuing Organization

Latest Regulations

1882 Results