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Latest Regulations
29 Results
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Revision Explanation of the Announcement on Matters Related to the Filing of Class I Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20220811
Registration & Filing
2022-08-11
2022-08-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration on Matters Related to the Filing of Class I Medical Devices (No. 62 of 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2022年第62号
Registration & Filing
2022-08-11
2022-08-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Issuing Technical Guidelines for Compliance with Basic Principles of Safety and Performance of Medical Devices by the Equipment Review Center of the National Medical Products Administration (No. 29, 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第29号
Registration & Filing
2022-07-13
2022-07-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Guiding Principles for Registration and Application Materials of influenza Virus Nucleic Acid Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f4
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Application Materials of influenza Virus Antigen Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f3
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Application of Self testing Blood Glucose Monitoring Systems (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f1
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Application Materials of Quantitative Detection Reagents for Tumor Markers (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f2
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Pathogen Specific M-type Immunoglobulin Qualitative Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f5
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice on Matters Related to Technical Review during the Transition Period of the Implementation of New Regulations (No. 14, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第14号
Registration & Filing
2021-10-28
2021-10-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Announcement No. 122 of 2021 on the Requirements for Publishing Registration and Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第122号
Registration & Filing
2021-09-30
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
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