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
Notice of the National Medical Products Administration on Issuing Management Guidelines for Management Representatives of Medical Device Manufacturing Enterprises
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2018年第96号
Supervision & Inspection
2018-09-30
2018-09-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on the Cleaning Results of Normative Documents for Medical Devices (1998-2013)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第37号
Supervision & Inspection
2018-09-27
2018-09-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Interpretation of Management Documents for Configuration and Use of Large Medical Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NHFPC-20180613
Usage,Supervision & Inspection
2018-06-13
2018-06-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
National Heath …
Work Documents
Medical Device
Notice of the National Medical Products Administration on Further Strengthening the Supervision of Drugs, Medical Devices, and Cosmetics during the Period of Institutional Reform
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监[2018]19号
Supervision & Inspection
2018-06-05
2018-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Decision of the State Council on the Adjustment of Administrative Organ Responsibilities Related to Administrative Regulations in the Reform of State Council Institutions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国发[2018]17号
Supervision & Inspection
2018-06-05
2018-05-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
State Council …
Normative Documents
IVD
Notice of the Office of the National Medical Products Administration on Issuing the Management Norms for the Revision of the Guiding Principles for Technical Review of Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监办[2018]13号
Supervision & Inspection
2018-05-29
2018-05-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the General Office of the State Administration on Issuing the Assessment and Evaluation Plan of the Medical Device Standardization Technical Committee
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办科[2018]38号
Supervision & Inspection
2018-03-21
2018-03-15
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the General Office of the State Council on the Implementation of the Measures for the Supervision and Administration of Online Sales of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械监[2018]31号
Supervision & Inspection,Distribution
2018-02-27
2018-02-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Guiding Opinions of the State Administration for Food and Drug Administration and the Ministry of Science and Technology on Strengthening and Promoting Innovation in Food and Drug Technology
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监科[2018]14号
Supervision & Inspection
2018-01-30
2018-01-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
The State Administration for Food and Drug Administration and the Ministry of Public Security have issued a notice on increasing the enforcement of food and drug safety and strictly implementing the provisions of punishing individuals for illegal acts of food and drug
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监法[2018]12号
Supervision & Inspection
2018-01-24
2018-01-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
«
1
2
3
4
5
6
7
8
9
…
13
14
»
×
