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
Announcement of the National Food and Drug Administration on the Implementation of 96 Medical Device Industry Standards, including "Dentistry Base Polymers Part 1: Denture Base Polymers"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2011年第106号
Product Type Testing
2011-12-31
2013-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices, including influenza Virus Nucleic Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]540号-f1
Registration & Filing
2011-12-23
2011-12-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices Including influenza Virus Antigen Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]540号-f2
Registration & Filing
2011-12-23
2011-12-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Explanation on Issues Related to GB 9706.1-2007 in the Product Standards for Medical Electrical Equipment Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20111101
Product Type Testing
2011-11-01
2012-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Announcement on Issuing the First Amendment to Five Industry Standards, including YY/T0740-2009 Technical Conditions for Medical Angiography X-ray Machines
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2011年第45号
Product Type Testing
2011-05-27
2011-05-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Disposable Surgical gowns
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f12
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Disposable Vacuum Blood Collection Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f9
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Natural Rubber Latex and Rubber Condom Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f11
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including 3A Class Semiconductor Laser Therapy Machine Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f3
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing 9 Guiding Principles for Technical Review of in vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy Recovery Test)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f6
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
«
1
2
…
170
171
172
173
174
175
176
177
178
179
»
×