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
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240828
Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing
2024-08-28
2024-08-26
Status
Issued By
Level of Legal Effect
Product Category
Draft
UNKNOWN
UNKNOWN
UNKNOWN
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第20号
Product Type Testing
2024-06-13
2024-06-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Industry Standard Management Measures
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局令2023年第86号
Product Type Testing
2023-12-27
2024-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
Administrative Regulations
Medical Device
National Standard Management Measures
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局令2022年第59号
Product Type Testing
2022-09-09
2023-03-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
SAMR/State Administration …
Departmental Rules
IVD
Notice on Publicizing the Catalogue and Scope of Application of Chinese Medical Device Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20220407
Product Type Testing
2022-04-07
2022-04-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
IVD
Announcement of the National Medical Products Administration on Issuing the Medical Device Industry Standard "General Technical Requirements for Oral Collagen Membranes" (No. 39 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第39号
Product Type Testing
2021-03-16
2022-04-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Forwarding Notice on Soliciting Opinions on the Recommended National Standard (Draft for Comments) for the Application of Medical Device Quality Management System in Regulations
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国质管标〔2021〕3号
Product Type Testing
2021-01-11
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Normative Documents
IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the standardization of medical devices (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20201231
Product Type Testing
2020-12-31
2020-12-31
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration on the Release of 34 Medical Device Industry Standards, including YY0341.1-2020 "Passive Surgical Implants - Bone Joining and Spinal Implants - Part 1: Special Requirements for Bone Joining Implants"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第108号
Product Type Testing
2020-10-21
2020-09-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Further Strengthening the Management of Compulsory Industry Standards for Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注[2020]72号
Product Type Testing
2020-07-09
2020-07-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
1
2
3
4
5
6
7
»
×
