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Latest Regulations
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ASC
DESC
Notice of the National Medical Products Administration on Issuing Guiding Principles for Classification and Definition of Artificial Intelligence Medical Software Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第47号
Pre-Market
2021-07-08
2021-07-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Summary of Attribute Definition Results for the First Batch of Pharmaceutical Device Combination Products in 2021
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210707
Pre-Market
2021-07-07
2021-07-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Combination Product
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Medical Assistance Decision Software (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210609
Pre-Market
2021-06-09
2021-06-09
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Announcement of the State Medical Products Administration on the Work Procedure for Dynamic Adjustment of the Classification Catalogue of Medical Devices (No. 60 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第60号
Pre-Market
2021-05-08
2021-04-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Moxibustion Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210426
Pre-Market
2021-04-26
2021-04-26
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Moxibustion Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210426
Pre-Market
2021-04-26
2021-04-26
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Defining the Attributes of Pharmaceutical Device Combination Products (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210416-1
Pre-Market
2021-04-16
2021-04-16
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Combination Product
Notice on Soliciting Opinions on the Guiding Principles for Defining the Attributes of Pharmaceutical Device Combination Products (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210416-1
Pre-Market
2021-04-16
2021-04-16
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Combination Product
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Sports Rehabilitation Training Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210416-2
Pre-Market
2021-04-16
2021-04-16
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Radiofrequency Beauty Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210416-4
Pre-Market
2021-04-16
2021-04-16
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
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