• 2026-04-23 07:36:58

The webinar hosted by Qualtech in March takes a closer look at how medical device studies are conducted in the United States. Covering US FDA classification, IDE and IRB pathways, and study design, it connects regulatory frameworks with their practical application in study execution. This recap highlights key considerations shaping how studies are structured and managed in the US context.

• 2026-02-25 04:43:48

Thai FDA has provided recommendations on applicable international standards for particular types of active medical devices to support medical device registration in Thailand. These standards are presented as advisory references only and are intended to assist the registrants in preparing relevant test reports in accordance with the ASEAN Common Submission Template Dossier (CSDT).

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 2025-12-26 03:21:16

On November 4, 2025, the NMPA released the revised Good Manufacturing Practice for Medical Devices (GMP), the regulation will officially enter into force on November 1, 2026, at which time the 2014 version shall be repealed.

• 2025-11-26 07:23:46

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

• 2025-10-27 02:31:38

PMDA released a notification for the medical industry to reference the "Practical Guide for Radio Wave Management of Medical Telemetry Devices", prepared and released by the Electromagnetic Compatibility Conference Japan (EMCC). The purpose of the guide is to provide operational guidelines for radio management of medical telemeter systems (wireless physiological monitoring devices used in hospitals and healthcare facilities), ensuring interference prevention, safety, and proper use. In addition, the guide is intended to promote the development and utilization of practical manuals tailored to individual user groups, such as nurses, clinical engineers, and hospital administrators or administrative staffs.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-07-10 09:00:31

Vietnam is experiencing a significant rise in cardiovascular disease (CVD). This article highlights the alarming rate at which heart diseases are affecting the population and its substantial impact on the Vietnamese health. The growing burden of CVD is also creating a significant market for cardiac medical instruments to prevent, detect and treat CVD in Vietnam.

• 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

• 2025-05-06 08:38:10

Stay ahead in China's evolving medical device regulations! Join our FREE webinar to master NMPA registration, technical reviews, and post-market compliance. Gain expert strategies to accelerate approvals and avoid risks—whether entering the market or optimizing compliance. Secure your spot now!