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 Office of the State Food and Drug Administration on Issuing Six Guiding Principles, including the Technical Review of Enzyme Linked Immunoassay Reagent Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2013]3号-f1
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the Office of the National Food and Drug Administration on Issuing Six Guiding Principles, including Technical Review of Registration of Nucleic Acid Amplification Test Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2013]3号-f3
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the Office of the State Food and Drug Administration on Issuing Six Guiding Principles for the Technical Review of Registration of Biochip Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2013]3号-f5
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the Office of the State Food and Drug Administration on Issuing Six Guiding Principles, including Technical Review for Registration of Disposable Dialyzers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2013]3号-f6
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Basic requirements for registration and application materials of immunohistochemical antibody reagents and detection kits
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20130104
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice of the Office of the National Food and Drug Administration on the Work Requirements for the Implementation of YY0505-2012 Medical Device Industry Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械[2012]151号
Product Type Testing
2012-12-19
2012-12-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Announcement on the Implementation of YY0505-2012 "Medical Electrical Equipment Part 1-2: General Safety Requirements and Parallel Standards: Electromagnetic Compatibility Requirements and Tests" Medical Device Industry Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2012年第74号
Product Type Testing
2012-12-17
2014-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the State Food and Drug Administration on the Classification and Definition of 17 Products, including Ultrasound Tumor Therapy System
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2012]361号
Pre-Market
2012-12-10
2012-12-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Notice of the State Food and Drug Administration on Issuing the Procedures for the Review and Handling of Administrative Reconsideration Cases by the State Food and Drug Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监法[2012]352号
Supervision & Inspection
2012-12-03
2012-12-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Notes on registration and application materials for dental mobile phones and related accessories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20121116
Registration & Filing
2012-11-06
2012-11-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
«
1
2
…
168
169
170
171
172
173
174
…
178
179
»
×