Home
Regulatory Database
Learning Portal
About Us
Contact Us
English
English
简体中文
Log in
Sign Up
Regulation Title
Regulation NO
Product Life Cycle
Pre-Market
Product Type Testing
Clinical Evaluation
Registration & Filing
Manufacturing
Distribution
Usage
Supervision & Inspection
Search
FILTER
Product Life Cycle
Pre-Market
Product Classification
Labeling & UDI
Product R&D
Innovative Medical Devices
Naming Rules
Developing Experiments
Registration Units
IFU & Labeling
Product Type Testing
Product Techincial Requirements
Product Registration Testing
Testing Centers
Self Testing
Standards
Clinical Evaluation
Clinical Trial Site
IVD Clinical Evaluation
Clinical Trial
Medical Device Clinical Evaluation
Ethical Review
GCP
Clinical Evaluation Exemption
Registration & Filing
Certificate Issuance
Registration Dossier
Reviewing Process
Registration Issues
Efiling (eRPS)
Application Acceptance
Fliing Review
Supplmental Phase
Pre-review
Services of Documents
Registration Fees
QMS Inspection
Master Files
Expert Consultation
NMPA Consultation
Prioriity Approval
Conditional Approval
Urgent Approval
IFU & Labeling
Online Application
Manufacturing
Application Acceptance
Certificate Issuance
GMP
Contract Manufacturing
Distribution
Application Acceptance
Certificate Issuance
GSP
Advertisement
Recall
Usage
Usage Management
Disposable Medical Devices
Adverse Events
Supervision & Inspection
Regulator
Penalties
Insepction Plan
Insepctor
Inspection Results
Management Practices
Status
Vaild
Draft
Obsolete
Level of Legal Effect
Law
Administrative Regulations
Departmental Rules
Normative Documents
Announcements
Work Documents
Guidelines
Review Key Points
Product Categories
Medical Device
Combination Product
Non-Medical Device
IVD
IVD Regulated as Pharmaceuticals
Issuing Organization
CMDE/Center for Medical Device Evaluation
NMPA/National Medical Products Administration
NIFDC/National Institutes for Food and Drug Control
Center for Medical Device Standardization Administration
Ministry of Justice of the Peoples Republic of China
State Council of the People's Republic of China
National Heath Commission of the People's Republic of China
Ministry of Science and Technology of the People’s Republic of China
Ministry of Finance of the People’s Republic of China
National Health Security Administration
SAMR/State Administration for Market Regulation
Latest Regulations
1220 Results
Sort By
Issue Date
Newest
Oldest
Title
ASC
DESC
Key points for technical evaluation of imaging ultrasound artificial intelligence software (process optimization functions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f1
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for performance evaluation and evaluation of artificial intelligence analysis software for pathological images
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f2
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for clinical evaluation and evaluation of artificial intelligence analysis software for pathological images
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f3
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for performance evaluation and evaluation of flow cytometry artificial intelligence analysis software for blood diseases
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f4
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Guiding Principles for Registration and Review of Blood Melting Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f1
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding principles for registration and review of medical respiratory humidifiers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f2
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding principles for registration and review of intestinal hydrotherapy machines
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f3
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding principles for registration review of medical molecular sieve oxygen concentrators
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f4
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of bladder ultrasound scanners
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f5
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of disposable peritoneal dialysis catheters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f6
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
«
1
2
…
40
41
42
43
44
45
46
…
121
122
»
×
