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Latest Regulations
1882 Results
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Issue Date
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Title
ASC
DESC
Interpretation of Announcement on Matters Related to the Production of Imported Medical Device Products by Enterprises within China
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20200925
Registration & Filing
2020-09-25
2020-09-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Notice of the National Medical Products Administration on Issuing Six Guiding Principles, including Balloon Dilation Catheters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f1
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles, including Requirements and Evaluation of Needle Injury Protection Devices for Infusion Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f2
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for the Evaluation of Fatigue Performance of Biotype Femoral Stem and Stem
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f3
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles, including the Validation of Virus Inactivation Process for Allogeneic Implantable Medical Devices (Revised in 2020)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f4
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice from the National Medical Products Administration on Issuing Six Guiding Principles for 3D Printing of Patient Matching Mandibular Prostheses
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f5
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Personalized Matching of Bone Implants and Tools, including Medical and Industrial Mutual Quality Control
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f6
Registration & Filing
2020-09-24
2020-09-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (Revised in 2020)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第61号
Clinical Evaluation
2020-09-18
2020-09-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Revision Explanation of the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (2020 Revision)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20200918-1
Clinical Evaluation
2020-09-18
2020-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
Establish a project team evaluation system for high-quality, efficient, and scientific evaluation
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200828-3
Registration & Filing
2020-08-28
2020-08-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
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