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On March 16, 2026, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) issued an official circular updating the regulatory requirements for pr…

1. Background The Association of Southeast Asian Nations (ASEAN) was established in 1967 and currently comprises 10 member states, including Indonesia…

The 93rd China International Medical Equipment Fair (CMEF) will be held from April 9–12, 2026, at the National Exhibition and Convention Center (NECC)…

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

Who Can Act as the Applicant for Medical Device Registration in Macau? Under Law No. 12/2025 – Regulation on the Supervision and Administration of Med…

In the process of medical device registration in Indonesia, product labeling may appear to be a minor detail. In practice, however, it is one of the c…

WHX Dubai (formerly Arab Health) is the largest and most influential healthcare exhibition in the Middle East, bringing together the most comprehensiv…

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…

With the arrival of the new year comes new opportunities. GRZAN Group is ready to embark on its 2026 international journey—beginning in Dubai. The WHX…

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