Regulatory

Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第1号 Usage,Distribution,Manufacturing 2018-08-13 2019-01-01

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

Notice on Issuing the Management Measures for the Configuration and Use of Large Medical Equipment (Trial)

Regulation No. Product LifeCycle Issued Date Implemented Date 国卫规划发[2018]12号 Usage 2018-06-13 2018-05-22

Status Issued By Level of Legal Effect Product Category Valid National Heath … UNKNOWN UNKNOWN

Interpretation of Management Documents for Configuration and Use of Large Medical Equipment

Regulation No. Product LifeCycle Issued Date Implemented Date NHFPC-20180613 Supervision & Inspection,Usage 2018-06-13 2018-06-13

Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device

Notice on Issuing the Implementation Rules for the Management of Class A Large Medical Equipment Configuration License

Regulation No. Product LifeCycle Issued Date Implemented Date 国卫规划发[2018]14号 Usage 2018-06-13 2018-05-30

Status Issued By Level of Legal Effect Product Category Valid National Heath … Normative Documents Medical Device

The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"

Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08

Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents Combination Product

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 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 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 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 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 of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第154号 Usage,Distribution,Manufacturing 2016-09-22 2016-09-19

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

Measures for Quality Supervision and Management of Medical Device Use

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第18号 Usage 2015-10-21 2016-02-01

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

Medical Device Sampling and Adverse Event Monitoring Part (1)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-3 Supervision & Inspection,Usage 2015-01-22 2015-01-22

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

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Management Measures for Monitoring and Reevaluation of Adverse Events in Medical Devices

Notice on Issuing the Management Measures for the Configuration and Use of Large Medical Equipment (Trial)

Interpretation of Management Documents for Configuration and Use of Large Medical Equipment

Notice on Issuing the Implementation Rules for the Management of Class A Large Medical Equipment Configuration License

The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and 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 of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Measures for Quality Supervision and Management of Medical Device Use

Medical Device Sampling and Adverse Event Monitoring Part (1)