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Latest Regulations

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Announcement of the National Medical Products Administration on approving the release of two medical device industry standards, including YY0462-2018 Dental Gypsum Products, and one amendment form
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第38号 Product Type Testing 2018-06-14 2018-06-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Medical Products Administration on approving the release of 8 medical device industry standards and 2 modification orders, including YY/T0127.13-2018 "Biological Evaluation of Oral Medical Devices Part 13: Oral Mucosal Stimulation Test"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第4号 Product Type Testing 2018-04-17 2018-04-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on approving the release of 16 medical device industry standards, including YY0285.5-2018 "Sterile catheters for single use in intravascular catheters - Part 5: Peripheral catheters with sleeve needles"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第27号 Product Type Testing 2018-02-24 2019-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on approving the release of 9 medical device industry standards, including YY0645-2018 "Continuous Blood Purification Equipment"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第8号 Product Type Testing 2018-01-19 2019-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the General Office of the State Administration on Doing a Good Job in the Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]187号 Product Type Testing 2018-01-03 2017-12-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Doing a Good Job in the Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]187号 Product Type Testing 2018-01-03 2017-12-29
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 6 medical device industry standards, including YY/T0588-2017 Flow Cytometer
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第151号 Product Type Testing 2017-12-05 2018-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on the Clearing Results of Normative Documents Involved in the Reform of "streamlining administration, delegating powers, and improving services"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第136号 Product Type Testing 2017-11-17 2017-11-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on Abolishing Two Medical Device Industry Standards, including YY/T0127.2-2009 Biological Evaluation of Oral Medical Devices Unit 2: Test Methods Acute Systemic Toxicity Test: Venous Pathway
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第130号 Product Type Testing 2017-11-01 2017-10-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the State Administration on approving the release of 7 medical device industry standards, including YY/T0661-2017 "Semi crystalline Polylactide Polymer and Copolymer Resin for Surgical Implants"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第118号 Product Type Testing 2017-09-25 2018-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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