Regulatory

Announcement of the State Administration on approving the release of 7 medical device industry standards, including YY/T0661-2017 "Semi crystalline Polylactide Polymer and Copolymer Resin for Surgical Implants"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第118号 Product Type Testing 2017-09-25 2018-10-01

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

Announcement of the State Administration on Issuing the Identification and Quantitative Supplementary Testing Methods for Fluorescent Substances in PVC Infusion and Blood Transfusion Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第110号 Product Type Testing 2017-09-15 2017-09-12

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

Announcement of the State Administration on Approving the Issuance of Four Medical Device Industry Standards, including YY/T 1574-2017 Guidelines for Alginate gel Fixation or Microcapsulation of Tissue Engineering Medical Device Products

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第99号 Product Type Testing 2017-08-18 2018-09-01

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

Announcement of the State Administration on approving the release of eight medical device industry standards and one amendment form, including "Sterile catheters for single use in intravascular catheters Part 1: General requirements"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第84号 Product Type Testing 2017-07-17 2017-07-17

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

Announcement of the State Administration on Abolishing 21 Medical Device Industry Standards, including YY0097-1992 Magnetic Therapy Health Cup

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第82号 Product Type Testing 2017-07-12 2017-07-07

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

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Announcement of the State Administration on approving the release of 28 medical device industry standards, including the "Disposable Centrifuge Plasma Seperator"

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第49号 Product Type Testing 2017-05-02 2018-04-01

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

Management Measures for Medical Device Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第33号 Pre-Market,Product Type Testing 2017-04-26 2017-07-01

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

FILTER

Product Life Cycle

Status

Level of Legal Effect

Product Categories

Issuing Organization

Latest Regulations

97 Results

Announcement of the State Administration on approving the release of 7 medical device industry standards, including YY/T0661-2017 "Semi crystalline Polylactide Polymer and Copolymer Resin for Surgical Implants"

Announcement of the State Administration on Issuing the Identification and Quantitative Supplementary Testing Methods for Fluorescent Substances in PVC Infusion and Blood Transfusion Devices

Announcement of the State Administration on Approving the Issuance of Four Medical Device Industry Standards, including YY/T 1574-2017 Guidelines for Alginate gel Fixation or Microcapsulation of Tissue Engineering Medical Device Products

Announcement of the State Administration on approving the release of eight medical device industry standards and one amendment form, including "Sterile catheters for single use in intravascular catheters Part 1: General requirements"

Announcement of the State Administration on Abolishing 21 Medical Device Industry Standards, including YY0097-1992 Magnetic Therapy Health Cup

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Announcement of the State Administration on approving the release of 28 medical device industry standards, including the "Disposable Centrifuge Plasma Seperator"

Management Measures for Medical Device Standards