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Latest Regulations

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Guidelines for Naming Common Names of Medical Software
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第48号-f4 Pre-Market 2021-07-15 2021-07-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Naming Common Names of Respiratory, Anesthetic, and First Aid Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第48号-f5 Pre-Market 2021-07-15 2021-07-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Naming Common Names of Obstetrics and Gynecology, Assisted Reproductive and Contraceptive Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第48号-f6 Pre-Market 2021-07-15 2021-07-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Guiding Principles for Classification and Definition of Artificial Intelligence Medical Software Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第47号 Pre-Market 2021-07-08 2021-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Summary of Attribute Definition Results for the First Batch of Pharmaceutical Device Combination Products in 2021
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210707 Pre-Market 2021-07-07 2021-07-07
Status Issued By Level of Legal Effect Product Category Valid Center for … Work Documents Combination Product
Announcement of the National Medical Products Administration on Publishing the Catalogue of Class II Medical Devices Exempted from Business Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第86号 Distribution 2021-06-30 2021-06-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Guidelines for Technical Review of Registration of Vision Screening Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f1 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Breast X-ray System Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f2 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Application of Shelf Life of Passive Implantable Medical Devices (Revised in 2021) (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210610-1 Registration & Filing 2021-06-10 2021-06-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Medical Assistance Decision Software (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210609 Pre-Market 2021-06-09 2021-06-09
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
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