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
67 Results
Sort By
Issue Date
Newest
Oldest
Title
ASC
DESC
Announcement of the National Medical Products Administration on the Release of 41 Medical Device Industry Standards and 2 Amendment Orders, including YY0485-2020 "Disposable Cardiac Arrest Infusion Device"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年76号
Product Type Testing
2020-07-09
2020-06-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on Issuing 12 Medical Device Industry Standards and 1 Amendment Order, including YY0336-2020 "Disposable Sterile Vaginal Dilator"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第48号
Product Type Testing
2020-04-09
2020-03-31
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Forwarding Explanation on "Special Design Sutures" in the Applicable Scope of Industry Standards YY1116-2020 and YY0167-2020
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20200310
Product Type Testing
2020-03-10
2020-03-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
National Health …
Work Documents
Medical Device
Announcement of the National Medical Products Administration on Issuing 24 Medical Device Industry Standards and 6 Revision Orders, including YY0833-2020 General Technical Requirements for Limb Pressure Therapy Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第20号
Product Type Testing
2020-03-06
2020-02-21
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on Issuing Six Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第18号
Product Type Testing
2020-03-02
2020-02-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on the Release of 7 Medical Device Industry Standards and 1 Amendment Order, including YY0167-2020 Non Absorbable Surgical Sutures
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第21号
Product Type Testing
2020-03-02
2020-02-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Management Measures for Compulsory National Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局令2020年第25号
Product Type Testing
2020-01-06
2020-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
Departmental Rules
IVD
Announcement of the National Medical Products Administration on the Conversion of 40 Mandatory Medical Device Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance", into Recommended Industry Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第106号
Product Type Testing
2019-12-17
2019-12-09
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on the Release of 21 Medical Device Industry Standards and 1 Amendment Order, including YY/T 0464-2019 "Disposable Hemoperfusion Devices"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第84号
Product Type Testing
2019-11-13
2019-10-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Explanation of "Typical Application Lenses" in Article 4.2.4.3 of GB11417.3-2012 Ophthalmic Optics - Part 3: Soft Contact Lenses
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
光秘函字[2017]2号
Product Type Testing
2019-08-12
2017-02-15
Status
Issued By
Level of Legal Effect
Product Category
Valid
Zhejiang Medical …
Normative Documents
Medical Device
«
1
2
3
4
5
6
7
»
×