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- India Grants Import License Grace Period for Class A/B Devices September 30, 2022
- India Issues Draft Notification for Exempting Certain Class A Medical Devices September 29, 2022
- Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR September 14, 2022
- Vietnam’s DMEC Provides Update on Issuance of C/D Licenses September 14, 2022
- Philippines FDA Publishes Revised Draft of New IVD Regulations September 9, 2022
- Taiwan’s New TCP III in Effect as of January 1, 2022 August 31, 2022
- Hong Kong to Pilot Prioritizing Some Listed Medical Devices August 30, 2022
- How New EU MDR Requirements Will Affect Registrations in Asia August 12, 2022
- Thai FDA Implements Initial Screening Step to Submission Process August 7, 2022
- Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue August 5, 2022
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NMPA Issues New Guidance for Medical Device Software in China
/in China, Latest News/by Bryan GilburgIn March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.
Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance
/in Latest News, Singapore/by Kenna RasiklalIn April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.
China Fully Implements UDI Requirements for Class 3 Medical Devices
/in China, Latest News/by Bryan GilburgBeginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
Korea MFDS Implements Medical Device Monthly Reporting Requirements
/in Latest News, South Korea/by Sarah BaikThe Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
Philippines FDA Bans Mercury-Added Products
/in Latest News, Philippines/by Charmaine RosonReleased on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.
Taiwan FDA Medical Device Advertising Requirements
/in Latest News, Taiwan/by Eric LeungThe Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
TFDA Expands Reliance Route to Include All B/C/D Singapore Registrations
/in Latest News, Thailand/by Bryan GilburgOn June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.
Thai FDA Announces New Application and Query Response Timelines
/in Latest News, Thailand/by Bryan GilburgOn April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.