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Opening Summary The European Commission has adopted a new delegated regulation amending Article 61 of Regulation (EU) 2017/745 (MDR), significantly ex…

Are you planning to expand your business into Malaysia?Are the numerous regulatory requirements leaving you confused?Which products must undergo CAB c…

ndatory Use of First Four EUDAMED Modules from 28 May 2026 To enhance transparency and safety in medical device regulation, the European Commission ha…

On February 3, 2026, the U.S. Food and Drug Administration (FDA) officially published the final guidance titled “Computer Software Assurance for Produ…

Recently, Health Canada announced an update to the application and review fee structure for medical device licences.

Recently, the Vietnamese Ministry of Health (MOH) officially promulgated Circular No. 57/2025/TT-BYT.

Are aesthetic medical products regulated by ANMAT in Argentina?

The Directive has been formally gazetted, with mandatory enforcement commencing on 1 June 2026.

To continuously enhance the safety, quality, and performance of medical devices used in public healthcare institutions, the Hong Kong Department of He…

The European Commission has recently published its long-anticipated proposal to revise the Medical Device Regulation (MDR) and the In Vitro Diagnostic…

July 10, 2025, has become a watershed moment for Brazil's medical device market regulation—the Unique Device Identification (UDI) compliance requireme…

ReOn 11 December 2025, the Vietnamese Ministry of Health (MOH) officially promulgated a key regulatory decision introducing 10 standardized and fully …