News Center

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) has issued Resolution 236/2026, implementing Decree 892/25, which rela…

Argentina's ANMAT introduces a notification-based filing system for Class I/II medical devices and non-cold-chain IVDs, …

MDCG has clarified who may assign UDI-DIs in manufacturer-distributor private-label scenarios. Learn about UDI assignmen…

Learn about Malaysia MDA medical device re-registration requirements, including the application process, CAB assessment,…

I. Key Compliance Requirements for Contract Manufacturing Key Point 1: Contractor Qualification Assessment + Continuous Monitoring Throughout the Enti…

Medical device market access in Ecuador is regulated by the National Agency for Regulation, Control and Health Surveillance (ARCSA). All medical devic…

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

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…

Key Compliance Considerations for Medical Device Registration in Kenya.

This article interprets the Manual for Registration of Health Products at ANVISA (Manual para Registro de Materiais de Uso em Saúde na ANVIS…

1. Regulatory Authority & Framework Cosmetics in Colombia are regulated by: Decreto 677 de 1995 Decreto 219 de 2022 Resolución 1482 de 2021 Andean…