• 2025-02-20 10:09:30

Decree No. 04/2025/NĐ-CP, released on January 1st, 2025, by Vietnam MOH, extending the validity of import license until June 30, 2025, on the Decree amending and supplementing of Clause 2, Clause 3, and Clause 4, Article 76 of Decree No. 98/2021/ND-CP, as revised by Decree No. 07/2023/ND-CP, regarding medical device management.

• 2025-01-20 06:54:39

Register our FREE Webinar on 2025 Updates & Forecast for European Medical Device Regulations. Keep your medical device compliance in Europe up-to-date!

• 2025-01-22 09:19:30

In 2024, Qualtech Consulting Corporation achieved significant milestones, including expanding our services to support Korean MFDS registrations, celebrating the 10th anniversary of our Malaysian office, and hosting impactful webinars addressing regulatory and market opportunities in Europe, ASEAN, Brazil, and India. As we prepare for 2025, we are focused on expanding knowledge-sharing efforts, entering emerging markets such as Latin America and the Middle East, and celebrating 25 years of supporting medical device manufacturers globally.

• 2025-01-22 07:51:43

South Korea's rapidly aging population is driving a surge in chronic diseases, creating a lucrative market for medical devices. This article will highlight the growing demand for diagnostic tools, remote patient monitoring devices, wearable health trackers, cardiovascular and orthopedic devices, and diabetes care devices. With significant market projections, South Korea offers promising opportunities for foreign medical device manufacturers.

• 2025-01-22 07:36:15

The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) to streamline and enhance the recall processes for therapeutic goods in Australia. By reducing recall categories, simplifying procedural steps, and improving communication, the PRAC aims to foster efficiency and clarity for manufacturers and regulatory consultants. With implementation set for March 2025, stakeholders are encouraged to prepare for these reforms to ensure compliance and contribute to a safer therapeutic goods landscape.

• 2025-01-22 07:16:29

This guidance provides detailed instructions on assigning Master Unique Device Identification Device Identifiers (Master UDI-DIs) to contact lenses.

• 2025-01-22 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 2025-01-22 06:50:55

This document offers a detailed Q&A guide on the progressive implementation of Eudamed, focusing on the gradual roll-out of Eudamed, obligations related to supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.

• 2025-01-22 03:51:46

Medical Device Cluster (MDC) is rolling out the pilot run for the Change Management Program (CMP) for Software as Medical Device (SaMD), also known as a Standalone medical mobile application, including Machine Learning-Enabled SaMD. The program is voluntary and incorporated into HSA's existing Premarket Product Registration and Change Notification process. With effect from 4 December 2024, HSA also published new guidance document (GN-37) for the program.

• 2025-01-22 03:25:25

The US FDA has released a minor update of its final guidance, Global Unique Device Identification Database (GUDID) – Guidance for Industry and FDA Staff. This update incorporates forthcoming changes to the Global Medical Device Nomenclature (GMDN) field within the GUDID, along with other minor clarifications.