Medical Devices – Asia, South America, MENA, ROW Regulatory News September 2026

United Kingdom

MHRA–Malaysia collaboration (September 15, 2026)

UK MHRA reaffirmed its commitment to regulatory collaboration with Malaysia after high-level discussions in Kuala Lumpur.

Both sides’ representatives engaged in discussions aimed at fostering an environment conducive to healthcare innovation, clinical research, and life sciences. They agreed on a set of actionable steps to enhance the partnership, which includes further collaboration among experts and opportunities for teams to work together. This meeting is part of MHRA’s broader commitment to supporting innovation throughout the ASEAN region and around the world.

Argentina

ANMAT adapts the scheme of tariffs and procedures for Medicinal Specialties and Medical Products (September 01, 2026)

The National Administration of Drugs, Food and Medical Devices (ANMAT) informs that under Provision No. 5461/2026, the new payroll of tariffs and processes used in this Administration for Medicinal Specialties and Medical Products was approved. Additionally, maximum caps for specific tariffs are incorporated, establishing a maximum of $12,000,000 for Medical Specialties Imports and $5,000,000 for Medical Products Imports.  This new provision is in effect from September 1, 2026.

Australia

AI-enabled medical devices list updated (September 10, 2026)

TGA refreshed its public list of AI-enabled medical devices approved or those included on the Australian Register of Therapeutic Goods (ARTG). This update is relevant for sponsors who have incorporated AI-enabled medical device or machine learning (ML) technologies.

Please note that the ARTG list may not include all devices that utilize AI or ML technology. The search criteria only apply to devices where these terms are mentioned in the product name or intended purpose, and only if reported by the sponsor after March 2025.

Clinical evidence guidance for medical devices/IVDs (September 11, 2026)

TGA Updated guidance on clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs). This guidance acts as a reference for both industries and regulators. Sponsors and manufacturers can utilize this guidance to collect, compile, and present clinical evidence.

Egypt

Special Importation Committee Requests (September 11, 2026)

The Egyptian Drug Authority (EDA) issued the Special Importation Committee Request process. It applies to special or personal importation requests for medical devices. Applicants submit their request and documents through the EDA online platform and track its status there. Any comments or required corrections must be addressed through the platform before committee review. Once approved, the importation approval is released.

To Issue the Annual Import Plan for Registered Medical Devices (September 11, 2026)

The Egyptian Drug Authority (EDA issued the document and explains the Annual Import Plan for Registered MedicalDevices. It allows registered medical devices to be imported under an annual import approval, valid for one year from the date of issuance. The application, status tracking, required submissions, and approval are handled through the EDA electronic platform. The stated processing time is 72 hours, with a service cost of 2,000 Egyptian L.E.

Variation of Importation Annual Plan (September 11, 2026)

The Egyptian Drug Authority (EDA) describes the Variation of Importation Annual Plan service for medical devices. It allows applicants to request modifications to an existing annual importation plan. The request is submitted and tracked through the EDA electronic platform, with comments addressed online. The file is reviewed by the Special Importation Committee, after which the modified annual import plan is issued. The service fee is 500 Egyptian L.E.