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
18 Results
Sort By
Issue Date
Newest
Oldest
Title
ASC
DESC
Notice of the Office of the National Medical Products Administration on the Use of 100 Business Seals, including the Drug Registration Special Seal of the National Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监办[2018]15号
Registration & Filing
2018-05-31
2018-06-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Announcement of the State Administration on the Pilot Work of the Medical Device Registration System by the Shanghai Food and Drug Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2018年第1号
Registration & Filing
2018-01-09
2018-01-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the State Administration on the Use of Chinese Names for Registration Applicants and Filing Persons of Imported Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2017年第131号
Registration & Filing
2017-11-02
2017-10-31
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on Enabling the Online Appointment Acceptance System of the Administrative Acceptance Service Hall of the State Administration of China
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
ASHCFDA公告2017年第192号
Registration & Filing
2017-07-13
2017-07-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on Filling in Clinical Trial Institution Information in the Medical Device Registration Application Form
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
ASHCFDA公告2016年第179号
Registration & Filing
2016-10-28
2016-11-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement on Adjusting the Method of Receiving Registration Application Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CCRCFDA公告2015年第150号
Registration & Filing
2015-07-01
2015-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
Administrative Acceptance …
Announcements
IVD
Announcement on Relevant Issues Concerning the Acceptance of Medical Electrical Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CCRCFDA公告2015年第137号
Registration & Filing
2015-02-27
2015-02-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
Administrative Acceptance …
Announcements
Medical Device
Announcement on the Registration of Medical Devices Containing Cattle and Sheep Derived Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2006]407号
Registration & Filing
2006-08-02
2006-08-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
«
1
2
×
