Regulatory

Interpretation of the Measures for Supervision and Management of Online Sales of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171222-2 Supervision & Inspection,Distribution 2017-12-22 2017-12-22

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

Measures for the Administration of Internet Drug Information Services

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2004年第9号 Distribution 2017-11-21 2017-11-21

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

Decision of the State Food and Drug Administration on Amending Some Regulations

Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第37号 Distribution,Manufacturing 2017-11-21 2017-11-21

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

Announcement of the State Administration on Relevant Matters Concerning the Registration of Medical Device Operation

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第129号 Distribution 2017-11-03 2017-10-27

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

Interpretation of the Management Measures for Medical Device Recall II

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170524 Supervision & Inspection,Distribution 2017-05-24 2017-05-24

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

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

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

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170428 Supervision & Inspection,Distribution 2017-04-28 2017-04-27

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

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Interpretation of the Measures for Supervision and Management of Online Sales of Medical Devices

Measures for the Administration of Internet Drug Information Services

Decision of the State Food and Drug Administration on Amending Some Regulations

Announcement of the State Administration on Relevant Matters Concerning the Registration of Medical Device Operation

Interpretation of the Management Measures for Medical Device Recall II

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

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

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls