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Latest Regulations
238 Results
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DESC
Interpretation of the Classification Catalogue of In Vitro Diagnostic Reagents and the Notice on the Implementation of the Classification Catalogue of In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240511-1
Pre-Market
2024-05-11
2024-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
22/1000实时翻译 划译 Interpretation of the Announcement on Standardizing the Classification and Definition of Medical Device Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240511-2
Pre-Market
2024-05-11
2024-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20240409
Pre-Market
2024-04-09
2024-04-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20240327
Pre-Market
2024-03-27
2024-03-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f7
Pre-Market
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on the Classification and Definition of "Degradable Inflatable Hemostatic Sponge" Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注函〔2023〕631号
Pre-Market
2023-12-06
2023-12-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice on Publicly Soliciting Opinions on the Guiding Principles for Writing Medical Device Instructions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231108
Pre-Market
2023-11-08
2023-11-07
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Summary of the results of the third classification and definition of medical device products in 2023
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231103
Pre-Market
2023-11-03
2023-11-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Non-Medical Device
Notice on Soliciting Opinions on the Classification Rules for Medical Devices (Revised Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231010
Pre-Market
2023-10-10
2023-10-10
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Work Documents
Combination Product
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the draft of the Notice on Further Strengthening the Classification and Definition of Medical Device Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20230918
Pre-Market
2023-09-18
2023-09-18
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
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