New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
NMPA Emergency Approval of Imported Medical Devices in China: What this means for Foreign Manufacturers
The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards.
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
China Health Authority CDE Cancelling Face-to-Face Meetings with Companies to Prevent the Spread of Coronavirus
On February 3, 2020 China’s CDE has taken some measures to prevent and limit the spread of corona-virus out from the city of Wuhan.
NMPA PUBLISHES NEW GUIDELINE ON HOW TO ADDRESS LETTER OF DEFICIENCIES FOR MEDICAL DEVICE COMPANIES IN CHINA
On January 16, 2020 the NMPA publishes guideline explaining how medical device manufacturers should respond to a letter of deficiency from NPMA.
Changing of API registration in China NMPA- What you need to know
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,
China’s CMDE announces new regulations on the supervision and adminstration of customized medical devices for clinical trials.
China’s CMDE Announces new Regulations on the Supervision AND Administration of Customized Medical Devices for Clinical Trials
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.