• 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

• 2025-02-20 10:48:19

In 2025, the Thai FDA reinstated the auto approval system for specific Class 1 medical devices with additional conditions. The new "Positive List" identifies eligible devices by their GMDN generic names, expediting approvals while others require manual review.

• 2025-02-20 10:32:57

The FDA has released a draft on lifecycle management and marketing submission recommendations for devices that include AI-enabled software functions. This draft incorporates the Total Product Life Cycle (TPLC) approach and guiding principles for Good Machine Learning Practice (GMLP).

• 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 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.

• 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.