N E W S   A N D  R E G U L A T I ON S

01-24

2025

Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of drugs and medical Devices to Promote the high-quality development of the pharmaceutical industry Release time:03rd Jan. 2025
In order to thoroughly implement the important instructions and instructions of General Secretary Xi Jinping on the supervision of drugs and medical devices and the development of the pharmaceutica...

01-04

2025

Hainan Free Trade Port Boao Lecheng International Medical Tourism pilot zone clinical urgent need for the management of imported drugs and medical devices
People's governments of cities, counties and autonomous counties, and units directly under the provincial government:The "Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zon...

01-04

2025

The sixth meeting of the Leading Group of Clinical Real World Data Application Pilot work was held in Hainan
Release date:2024-11-29On November 22, the sixth meeting of the Clinical Real World data application Pilot work leading Group was held in Boao Lecheng, Hainan.The meeting affirmed the effectiveness...

01-11

2025

Announcement of the National Health Commission and NMPA on the Issuance of Temporary Import and Use Management requirements for Medical Devices in Urgent Need of Clinical Use in Medical Institutions (No. 97 of 2024)
In order to standardize the management of the temporary import and use of medical devices urgently needed by clinical institutions and further meet the urgent needs of clinical diagnosis and treatm...

08-06

2024

Announcement of the National Health Commission and NMPA on the Issuance of Temporary Import and Use Management requirements for Medical Devices in Urgent Need of Clinical Use in Medical Institutions (No. 97 of 2024)
In order to standardize the management of the temporary import and use of medical devices urgently needed by clinical institutions and further meet the urgent needs of clinical diagnosis and treatm...

08-30

2024

Hainan Free Trade Port Boao Lecheng International Medical Tourism pilot zone clinical urgent need for the management of imported drugs and medical devices
People's governments of cities, counties and autonomous counties, and units directly under the provincial government:The "Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zon...

03-30

2022

Interpretation of Quality Problems in Medical Device of Clinical Trials
1. One year validitytest report of medical device registration on clinical trial “Specification for quality management of medical deviceson clinical trials," Article VII: "quality inspection report...

03-30

2022

A Description of the Preferential Approval Procedure for Medical Devices
Issued on October 26, 2016A"medical device priority approval procedures"will be implemented on January 1, 2017,issued by the State Food and Drug Administration.17 procedures include the purpose and...
T H E   B R A N D  W E   S E R V E
Adaltis (Italy)
Common Sense (Israel)
DIASource (Belgium)
Medistim ASA (Norway)
Dr. Arabin (Germany)
Coroneo Inc (Canada)
Agilent
LSI Solutions (US)
Biomerica (US)
Reskin (Belgium)
Holland Trade Medical LTD
Care of Sweden AB (Sweden)
Pemco Inc. (US)
I2A (France)
Arterys (US)
Alfa Gate