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TGA Officially Releases 2026–27 Financial Year Fee Schedule The Australian Therapeutic Goods Administration (TGA) officially released its fee schedule…

Malaysia and China launch Phase 2 of the Medical Device Joint Evaluation Pilot Programme from July 1 to September 30, 20…

Malaysia MDA has withdrawn the COVID-19 test kit conformity assessment exemption. Learn about the new CAB requirements a…

FDA updated its 510(k) exemption list on June 5, 2026, adding five product codes and expanding exemptions to 13 categori…

In April 2026, the Medical Device Coordination Group (MDCG) published MDCG 2021-24 Rev.1 – Guidance on Classification of Medical Devices, introducing …

On April 1, 2026, Health Canada released the updated Guidance on Terms and Conditions for Class II to IV Medical Devices, which took effect immediatel…

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.