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Latest Regulations
16 Results
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ASC
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Explanation on the Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MJPRC-20180825-2
Pre-Market
2018-06-25
2018-06-25
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
Ministry of …
Administrative Regulations
IVD
Notice of the General Office of the State Administration on Issues Related to Textual Changes in the Instructions of In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械管[2016]117号
Pre-Market
2016-08-05
2016-08-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Interpretation of the Regulations on the Administration of Medical Device Registration II (Part 2 of the Regulations on the Administration of Medical Device Instructions and Labels)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CFDA-20150205-2
Pre-Market
2015-02-05
2015-02-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Notice on Soliciting Opinions on the Writing Standards for Common Orthopedic Trauma Product Instructions and the Reference Format for Trauma Product Instructions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20141223-1
Pre-Market
2014-12-23
2014-12-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Writing Two Instructions for Soft and Hydrophilic Contact Lenses
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2014年第3号-f1
Pre-Market
2014-04-17
2014-04-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Announcement on Matters Related to the Change and Filing of Instructions for Medical Device Products After Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2004]55号
Pre-Market
2004-03-11
2004-03-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
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