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Latest Regulations
1882 Results
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Title
ASC
DESC
Announcement on the Results of Defining the Attributes of the Thirteenth Batch of Pharmaceutical Device Combination Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第244号
Pre-Market
2019-07-18
2019-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Summary of Classification and Definition Results for the First Batch of Medical Device Products in 2019
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20190718
Pre-Market
2019-07-18
2019-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
National Health …
Work Documents
Combination Product
Opinions of the General Office of the State Council on Establishing a Professional and Professional Team of Drug Inspectors
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国办发[2019]36号
Supervision & Inspection
2019-07-18
2019-07-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
State Council …
Normative Documents
IVD
Notice of the General Office of the State Council on Issuing the Reform Plan for Managing High Value Medical Consumables
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国办发[2019]37号
Supervision & Inspection
2019-07-18
2019-07-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
State Council …
Normative Documents
IVD
Notice of the National Medical Products Administration on Recognizing the First Batch of Key Laboratories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监科外函[2019]82号
Clinical Evaluation
2019-07-15
2019-07-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice from the National Medical Products Administration on the Release of Independent Software for the Appendix of Medical Device Production Quality Management Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第43号
Manufacturing
2019-07-12
2019-07-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the National Medical Products Administration on the Requirements for Electronic Declaration of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第41号
Registration & Filing
2019-07-10
2019-08-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on the Delivery Procedure of Proof Documents for the Approval Results of Administrative Licensing Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第243号
Registration & Filing
2019-07-04
2019-08-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Interpretation of the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20190704
Manufacturing,Usage
2019-07-04
2019-07-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第53号
Manufacturing,Usage
2019-07-04
2020-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
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