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
138 Results
Sort By
Issue Date
Newest
Oldest
Title
ASC
DESC
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管〔2024〕32号
Supervision & Inspection
2024-03-19
2024-03-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Notice of the National Medical Products Administration on Issuing the Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监法〔2024〕11号
Supervision & Inspection
2024-02-23
2024-08-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Interpretation of "Quality Management Standards for Medical Device Operations" Part 2
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231212
Supervision & Inspection,Distribution
2023-12-11
2023-12-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
Interpretation of the Quality Management Standards for Medical Device Operations
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231208
Supervision & Inspection,Distribution
2023-12-08
2023-12-08
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2023年第153号
Supervision & Inspection,Distribution
2023-12-07
2024-07-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Administrative Regulations
Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration (Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20231019
Supervision & Inspection
2023-10-19
2023-10-19
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Quality Management Standards for Online Sales of Medical Devices (Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管函〔2023〕502号
Supervision & Inspection,Distribution
2023-09-18
2023-09-14
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Normative Documents
IVD
Notice on Issuing the 2023 National Medical Device Sampling Product Inspection Plan by the Comprehensive Department of the National Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管〔2023〕28号
Supervision & Inspection
2023-03-31
2023-03-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Revising and Issuing the Basic Catalogue of Government Information Active Disclosure by the National Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综〔2022〕58号
Supervision & Inspection
2022-06-07
2022-06-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Volume Procurement
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管〔2021〕84号
Supervision & Inspection
2021-09-18
2021-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
«
1
2
3
4
5
…
13
14
»
×
