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
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Intervertebral Fusion Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f6
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Dental Base Polymer Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f2
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing a Risk List and Inspection Points for the Production Process of 25 Medical Devices, including Disposable Sterile Syringes
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监械监[2016]37号
Supervision & Inspection,Manufacturing
2016-04-13
2016-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Technical guidelines for clinical evaluation of pulse oximeter equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20160405
Clinical Evaluation
2016-04-05
2016-04-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice of the State Administration on the Implementation of the Naming Rules for Common Names of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监械管[2016]35号
Pre-Market
2016-03-30
2016-03-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Announcement of the State Administration on the Approval and Release of 93 Medical Device Industry Standards, including YY 0053-2016 "Hemodialysis and Related Treatment Hemodialyzers, Hemodialysis Filters, Hemofilters, and Blood Concentrators"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2016年第74号
Product Type Testing
2016-03-23
2017-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the State Administration on Issuing Six Documents, including the Model Application and Approval Form for Ethical Review of Clinical Trials of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第58号
Clinical Evaluation
2016-03-23
2016-03-15
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
Medical Device
Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CFDA-20160323
Clinical Evaluation
2016-03-23
2016-03-23
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Work Documents
Medical Device
Quality Management Specification for Clinical Trials of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局&国家卫计委令2016年第25号
Clinical Evaluation
2016-03-23
2016-06-01
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
UNKNOWN
UNKNOWN
Notice on Relevant Issues in the Evaluation of Contact Lens Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20160316
Product Type Testing
2016-03-16
2016-03-16
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
«
1
2
…
148
149
150
151
152
153
154
…
178
179
»
×