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Latest Regulations
1789 Results
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Title
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DESC
Announcement on the Approval and Release of YY1298-2016 Medical Endoscope Capsule Endoscope Industry Standard No. 1 Revision Form for Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第7号
Product Type Testing
2019-01-29
2019-01-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Reply from the Comprehensive Department of the National Medical Products Administration on Clarifying the Relevant Issues Concerning the Verification of the Registration Quality Management System for Pre filled Catheter Washers (Physiological Saline)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注函[2019]17号
Registration & Filing
2019-01-15
2019-01-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Announcement on Issuing Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第101号
Supervision & Inspection
2018-12-28
2018-12-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on the Results of Defining the Attributes of the Eleventh Batch of Pharmaceutical Device Combination Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第229号
Pre-Market
2018-12-26
2018-12-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Announcement on the Results of Defining the Attributes of the Eleventh Batch of Pharmaceutical Device Combination Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第229号
Pre-Market
2018-12-26
2018-12-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Notice of the State Administration for Market Regulation on the Public Solicitation of Opinions on the Measures for the Supervision and Administration of Import Medical Device Agents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
SAMR-20181224
Supervision & Inspection,Usage,Distribution
2018-12-25
2018-12-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
Ministry of …
Work Documents
IVD
Notice on Issuing the Guiding Principles for Technical Review of Registration of Medical Laser Fiber Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2018年第130号
Registration & Filing
2018-12-24
2018-12-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Interim Provisions on Administrative Penalty Procedures for Market Supervision and Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
市监总局令2018年第2号
Supervision & Inspection
2018-12-21
2019-04-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
UNKNOWN
UNKNOWN
Interim Measures for Administrative Penalty Hearing in Market Supervision and Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
市监总局令2018年第3号
Supervision & Inspection
2018-12-21
2019-04-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
UNKNOWN
UNKNOWN
Announcement on the Approval and Release of 27 Medical Device Industry Standards, including YY0042-2018 High Frequency Jet Respirator
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第97号
Product Type Testing
2018-12-20
2019-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
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