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Latest Regulations
1789 Results
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Notice on Issuing the Operational Norms for Special Review Applications of Innovative Medical Devices by the Medical Device Technology Evaluation Center
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2018年第11号
Pre-Market
2018-11-29
2018-11-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Inspection Points and Determination Principles for Clinical Trials of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注[2018]45号
Clinical Evaluation
2018-11-28
2018-11-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice on Public Solicitation of Three Guiding Principles, including the Guiding Principles for Product Risk Assessment of Medical Device Marketing License Holders (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
ADRM-20181127-f1
Usage
2018-11-27
2018-11-27
Status
Issued By
Level of Legal Effect
Product Category
Draft
Drug Evaluation …
Guidelines
IVD
Notice on Publicly Soliciting Opinions on Three Guiding Principles, including the Guiding Principles for Medical Device Re evaluation (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
ADRM-20181127-f2
Usage
2018-11-27
2018-11-27
Status
Issued By
Level of Legal Effect
Product Category
Draft
Drug Evaluation …
Guidelines
IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Comparison of Same Variety of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20181122-2
Clinical Evaluation
2018-11-22
2018-11-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Implementing the Reform Measures of "Separation of Certificates and Licenses" and Further Promoting the Reform of the Medical Device Evaluation and Approval System
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注[2018]43号
Registration & Filing
2018-11-15
2018-11-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Announcement on the Results of Defining the Attributes of the Tenth Batch of Pharmaceutical Device Combination Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第224号
Pre-Market
2018-11-13
2018-11-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Announcement on the Results of Defining the Attributes of the Tenth Batch of Pharmaceutical Device Combination Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第224号
Pre-Market
2018-11-13
2018-11-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Notice on Issuing Three Registration Technical Review Guidelines for Zirconia Porcelain Blocks and Other Materials Used in All Ceramic Dentures
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2018年第116号-f2
Registration & Filing
2018-11-13
2018-11-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Guidelines for Technical Review of Three Registration Technologies, including Manual Wheelchairs
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2018年第116号-f3
Registration & Filing
2018-11-13
2018-11-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
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