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Latest Regulations
67 Results
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Announcement on the Implementation of 80 Medical Device Industry Standards, including YY0068.4-2009 "Medical Endoscopes - Part 4: Basic Requirements"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2009年第83号
Product Type Testing
2009-12-30
2011-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on the Implementation of 42 Medical Device Industry Standards, including YY0055.2-2009 "Dentistry - Photocuring Machine Part 2: Light Emitting Diode (LED) Lamp"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2009年第77号
Product Type Testing
2009-11-25
2010-12-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Announcement on the Implementation of 75 Medical Device Industry Standards, including YY0055.1-2009 "Dentistry - Photocuring Machine Part 1: Quartz Halogen Tungsten Lamp"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2009年第31号
Product Type Testing
2009-06-12
2010-12-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Issues to be noted in the registration product standards for hearing aids
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20090508
Product Type Testing
2009-05-08
2009-05-08
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Notice on Forwarding the Amendment to National Standard No. 1 of GB/T19634-2005 General Technical Conditions for Blood Glucose Monitoring Systems for Self testing of in vitro Diagnostic Testing Systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2006]6号
Product Type Testing
2005-12-06
2006-07-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice on Delaying the Implementation Date of National Standard GB4234-2003 Stainless Steel for Surgical Implants
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2005]521号
Product Type Testing
2005-09-02
2005-11-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice on the Release of 13 Medical Device Industry Standards, including Ethylene Oxide Sterilizers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2005]127号
Product Type Testing
2005-04-05
2006-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
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