In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.
In 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.
Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
Released 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.
The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
On 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.
On April 4, 2022, the TFDA updated their application query response policy to expedite reviews of applications and clear out a backlog of open applications.
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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
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- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022