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Latest Regulations
69 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
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监械管〔2024〕20号
Supervision & Inspection,Distribution
2024-07-30
2024-07-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Interpretation of "Quality Management Standards for Medical Device Operations" Part 2
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231212
Supervision & Inspection,Distribution
2023-12-11
2023-12-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
Interpretation of the Quality Management Standards for Medical Device Operations
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231208
Supervision & Inspection,Distribution
2023-12-08
2023-12-08
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2023年第153号
Supervision & Inspection,Distribution
2023-12-07
2024-07-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Quality Management Standards for Online Sales of Medical Devices (Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管函〔2023〕502号
Supervision & Inspection,Distribution
2023-09-18
2023-09-14
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Normative Documents
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Volume Procurement
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管〔2021〕84号
Supervision & Inspection
2021-09-18
2021-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Notice of the Comprehensive Department of the State Medical Products Administration on Issuing the Work Procedures for National Medical Device Quality Sampling and Inspection
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管〔2021〕46号
Supervision & Inspection
2021-04-13
2021-04-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Strengthening the Quality Supervision of Selected Coronary Stents in National Centralized Volume Procurement
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管[2020]103号
Supervision & Inspection
2020-11-11
2020-11-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on Further Doing a Good Job in Case Investigation and Handling
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综法[2020]63号
Supervision & Inspection
2020-06-15
2020-06-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
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