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Latest Regulations
1789 Results
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Title
ASC
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Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (Second Batch) (Guiding Principles for Technical Review of Registration of Disposable Respiratory Aspiration Catheters)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20161025-f19
Registration & Filing
2016-10-25
2016-10-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice of the General Office of the Ministry of Science and Technology on the Opening and Operation of the Online Application System for the Collection, Collection, Trading, Export, and Exit Approval of Human Genetic Resources
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国科办函社[2016]758号
Clinical Evaluation
2016-10-24
2016-10-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Normative Documents
IVD
Notice on Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (First Batch) (Guiding Principles for Technical Review of Registration of Disposable Oxygen Humidifiers)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20161020-f7
Registration & Filing
2016-10-20
2016-10-20
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice on the Public Solicitation of Opinions on the Technical Guidelines for Registration of Class II Medical Devices in 2016 (First Batch) (Guiding Principles for Technical Review of Registration of Disposable Sterile Surgical Membranes)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20161020-f1
Registration & Filing
2016-10-20
2016-10-20
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Human Red Blood Cell Anti typing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第131号
Registration & Filing
2016-09-30
2016-09-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2016年第154号
Usage,Distribution,Manufacturing
2016-09-22
2016-09-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Reply from the General Office of the State Administration on Relevant Issues Concerning the Business Registration of Blood Glucose Test strips and Other In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械监函[2016]629号
Distribution
2016-08-30
2016-08-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice on Soliciting Opinions on the Guiding Principles for Technical Review of Registration of Silver containing Dressings (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20160823-3
Registration & Filing
2016-08-23
2016-08-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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
Announcement of the State Administration on approving the release of 64 medical device industry standards, including YY0017-2016 Metal Orthopedic Plate for Bone Joint Implants
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2016年第129号
Product Type Testing
2016-07-29
2017-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
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