Regulatory

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

Reply from the General Office of the General Administration of the People's Republic of China on Relevant Issues Concerning the Retail Operation of Corneal Plastic Lenses

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2017]212号 Distribution 2017-04-13 2017-04-10

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

Letter on Soliciting Opinions on the Draft Measures for Investigating and Punishing Illegal Acts in the Operation of Online Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2017]30号 Supervision & Inspection,Distribution 2017-03-29 2017-03-27

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

Reply from the General Office of the State Administration on Relevant Issues Concerning the Business Registration of Blood Glucose Test strips and Other In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2016]629号 Distribution 2016-08-30 2016-08-29

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

Reply from the General Office of the State Council on Issues Related to the Suspected Operation of Unregistered Elastomer Impression Materials

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]534号 Supervision & Inspection,Distribution 2016-07-26 2016-07-26

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

Reply from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]646号 Supervision & Inspection,Distribution 2015-10-22 2015-10-22

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

Notice of the State Administration for Food and Drug Administration on Issuing the Guiding Principles for On site Inspection of Medical Device Operation Quality Management Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]239号 Supervision & Inspection,Distribution 2015-10-15 2015-10-15

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

Reply from the General Office of the State Administration for Food and Drug Administration on Issues Related to Individual Businesses Engaging in Medical Device Business Activities

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]533号 Distribution 2015-09-02 2015-09-02

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

Reply from the General Office of the State Administration for Food and Drug Administration on Relevant Issues Concerning the Operation of Ear Back Digital Hearing Aids with Exemption from Inspection

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]414号 Distribution 2015-07-14 2015-07-14

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

FILTER

Product Life Cycle

Status

Level of Legal Effect

Product Categories

Issuing Organization

Latest Regulations

31 Results

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

Reply from the General Office of the General Administration of the People's Republic of China on Relevant Issues Concerning the Retail Operation of Corneal Plastic Lenses

Letter on Soliciting Opinions on the Draft Measures for Investigating and Punishing Illegal Acts in the Operation of Online Medical Devices

Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices

Reply from the General Office of the State Administration on Relevant Issues Concerning the Business Registration of Blood Glucose Test strips and Other In Vitro Diagnostic Reagents

Reply from the General Office of the State Council on Issues Related to the Suspected Operation of Unregistered Elastomer Impression Materials

Reply from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents

Notice of the State Administration for Food and Drug Administration on Issuing the Guiding Principles for On site Inspection of Medical Device Operation Quality Management Standards

Reply from the General Office of the State Administration for Food and Drug Administration on Issues Related to Individual Businesses Engaging in Medical Device Business Activities

Reply from the General Office of the State Administration for Food and Drug Administration on Relevant Issues Concerning the Operation of Ear Back Digital Hearing Aids with Exemption from Inspection