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Latest Regulations
1789 Results
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Title
ASC
DESC
Notice on Issuing 9 Guiding Principles for Technical Review of in vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy Methodology Comparison)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f5
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice on Issuing 9 Guiding Principles including Technical Review for Registration of Contact Lens Care Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f1
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing 9 Guiding Principles including Technical Review for Registration of Breast Implant Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f2
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing 9 Guiding Principles, including Registration and Application Materials for Quantitative Detection Reagents of Tumor Markers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f7
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Announcement on the Implementation of 96 Medical Device Industry Standards, including YY0054-2010 Hemodialysis Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2010年第97号
Product Type Testing
2010-12-27
2012-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Guiding Principles for Issuing Registration and Application Materials for Self testing Blood Glucose Monitoring Systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2010]438号
Registration & Filing
2010-10-18
2010-10-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Announcement on Issuing the First Amendment to Two Medical Device Industry Standards, including YY/T0617-2007 Disposable Human Peripheral Blood Sample Collection Containers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2010年第75号
Product Type Testing
2010-10-11
2010-10-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice on Clarifying the Management Categories of Oral Products such as Calcium Hydroxide Paste
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2010]367号
Pre-Market
2010-09-07
2010-09-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Non-Medical Device
Notice on Publishing the Explanation of Chemical Performance Requirements for Interventional Medical Device Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20100301
Product Type Testing
2010-03-01
2010-04-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Notice on Strengthening the Supervision of the Production of Natural Latex Rubber Condoms
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2010]91号
Supervision & Inspection,Manufacturing
2010-02-26
2010-02-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
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