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Vietnam Diagnostic Imaging Center Hosts AI Software Conference
On April 15th the MEDLATEC Diagnostic Imaging Center (MEDIM) hosted a conference to discuss the current state of AI-based software in diagnostic imaging in Vietnam.
Thailand – Food and Drug Administration (TFDA)
Sales Channel Establishment or Virtual Master Distributor services available, enabling foreign manufacturers to sell directly to regional distributors.
India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline
On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.
China CMDE Supplementary Documents Submission Deadline Extended
On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.
UDI Labelling Mandatory for Certain Taiwan Medical Devices
In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.
Philippines FDA Extends CMDN Deadline to 2024
The Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to September 30, 2024.
India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses
India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.
China Continues to Implement UDI of Medical Devices with Third Batch Release
The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.