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Latest Regulations
132 Results
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Title
ASC
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Public solicitation of opinions on the Interim Measures for the Management of Medical Consumables in Basic Medical Insurance (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NHSA-20200608
Supervision & Inspection,Usage
2020-06-08
2020-06-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
National Health …
Work Documents
IVD
Notice of the National Medical Products Administration on Issuing the Management Measures for Quality Sampling and Inspection of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监械管〔2020〕9号
Supervision & Inspection
2020-03-13
2020-03-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the National Medical Products Administration on Issuing the Management Measures for Quality Sampling and Inspection of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监械管〔2020〕9号
Supervision & Inspection
2020-03-13
2020-03-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the General Office of the National Health Commission on Issuing the First Batch of National Key Management List for High Value Medical Consumables
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国卫办医函〔2020〕9号
Supervision & Inspection
2020-01-14
2020-01-08
Status
Issued By
Level of Legal Effect
Product Category
Valid
National Heath …
Normative Documents
Medical Device
Notice of the State Medical Products Administration on Issuing the Management Measures for Key Laboratories of the State Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监科外〔2019〕56号
Supervision & Inspection
2020-01-06
2019-12-31
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Interim Measures for the Administration of Advertising Review of Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局令2019年第21号
Supervision & Inspection,Distribution
2019-12-24
2020-03-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
Departmental Rules
IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监科外[2019]36号
Supervision & Inspection,Product Type Testing
2019-08-30
2019-08-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the General Office of the National Health Commission of the State Administration for Market Regulation on Establishing a Collaborative Working Group for the Pilot Work of the Unique Identification System for Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注[2019]76号
Supervision & Inspection
2019-08-27
2019-08-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
The Information Center of the National Medical Products Administration publicly solicits opinions on six information technology standards, including the "Basic Dataset for Medical Device Inspection (Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20190823-2
Supervision & Inspection
2019-08-23
2019-08-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Opinions of the General Office of the State Council on Establishing a Professional and Professional Team of Drug Inspectors
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国办发[2019]36号
Supervision & Inspection
2019-07-18
2019-07-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
State Council …
Normative Documents
IVD
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