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
1789 Results
Sort By
Issue Date
Newest
Oldest
Title
ASC
DESC
Guidelines for Registration and Review of Antibiotic Drug Sensitivity Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-2
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Human MTHFR Gene Polymorphism Testing Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-3
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Stability Studies of In Vitro Diagnostic Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-4
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Technical Review of Hepatitis C Virus Nucleic Acid Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-5
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Nucleic Acid Testing Reagents for Mycobacterium tuberculosis Composite Group (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-6
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Fully Automatic Chemiluminescence Immunoassay Analyzer (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-7
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Human Red Blood Cell Anti typing Reagent Registration (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-8
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Hepatitis B Virus Genotyping Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-9
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Clinical Trials of Medical Devices (Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231128
Clinical Evaluation
2023-11-28
2023-11-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Administrative Regulations
Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Ultrasound Devices for Cosmetic Purposes (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231123
Registration & Filing
2023-11-23
2023-11-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
«
1
2
…
24
25
26
27
28
29
30
…
178
179
»
×
