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Latest Regulations
7 Results
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Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240828
Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing
2024-08-28
2024-08-26
Status
Issued By
Level of Legal Effect
Product Category
Draft
UNKNOWN
UNKNOWN
UNKNOWN
Policy Interpretation on the Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20201125-1
Pre-Market
2020-11-25
2020-11-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Notice of the State Administration for Market Regulation and other departments on Issuing the Work Plan for Innovative Development of Drug and Medical Device Supervision in the Guangdong Hong Kong Macao Greater Bay Area
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国市监药[2020]159号
Pre-Market
2020-11-25
2020-09-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice on Issuing Guidelines for Writing Application Materials for Special Review of Innovative Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2018年第127号
Pre-Market
2018-12-18
2018-12-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Issuing the Operational Norms for Special Review Applications of Innovative Medical Devices by the Medical Device Technology Evaluation Center
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2018年第11号
Pre-Market
2018-11-29
2018-11-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Interpretation of the Special Review Procedure for Innovative Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20181105
Pre-Market
2018-11-05
2018-11-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration on Issuing the Special Review Procedure for Innovative Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第83号
Pre-Market
2018-11-05
2018-12-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
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