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Latest Regulations
17 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
国药监局通告2024年第22号
Clinical Evaluation
2024-06-14
2024-10-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240613
Clinical Evaluation
2024-06-13
2024-06-12
Status
Issued By
Level of Legal Effect
Product Category
Draft
UNKNOWN
UNKNOWN
UNKNOWN
Key points and determination principles for supervision and inspection of clinical trial institutions for medical devices (draft for second round solicitation of opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240312-f2
Clinical Evaluation
2024-03-12
2024-03-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
UNKNOWN
UNKNOWN
Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240312-f1
Clinical Evaluation
2024-03-12
2024-03-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
UNKNOWN
UNKNOWN
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Supervision and Inspection of Clinical Trial Institutions of Medical Devices (Draft for Solicitation of Opinions)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20230407
Clinical Evaluation
2023-04-07
2023-04-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the Second Batch of Key Laboratories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综科外函〔2021〕115号
Clinical Evaluation
2021-03-02
2021-02-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the National Medical Products Administration on the Recognition of the Second Batch of Key Laboratories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监科外函〔2021〕17号
Clinical Evaluation
2021-02-09
2021-02-07
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 Issuing the English Names of the First Batch of Key Laboratories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综科外函[2019]402号
Clinical Evaluation
2019-08-26
2019-08-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the National Medical Products Administration on Recognizing the First Batch of Key Laboratories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监科外函[2019]82号
Clinical Evaluation
2019-07-15
2019-07-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
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