• 2025-04-24 07:49:13

The National Medical Products Administration has further adjusted and optimized certain provisions of the Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China, originally issued in September 2020.

• 2025-04-24 08:15:56

The National Medical Products Administration has organized and revised the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial Projects, which will come into effect on May 1, 2025.

• 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.

• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2025-03-25 09:14:44

South Korea's newly enacted Digital Medical Products Act (DMPA) establishes a dedicated regulatory framework for AI-driven devices, digital therapeutics, and health apps, ensuring their safety, effectiveness, and quality. Taking effect in January 2025, the Act introduces risk-based classifications, software and cybersecurity requirements, and clear pathways for digital health product approvals, positioning Korea as a global leader in digital health regulation.

• 2025-03-26 06:09:21

While the Philippines' ambitious Universal Health Care Act and substantial government investment are creating a rapidly expanding market for medical devices, the nation's overwhelming reliance on imports starkly contrasts with its limited domestic manufacturing capabilities. This situation, however, creates an opening for overseas manufacturers to provide the needed medical devices and take advantage of the increasing market.

• 2025-03-25 05:07:23

China's State Council has issued key amendments to the Regulations on the Supervision and Administration of Medical Devices. The updates broaden emergency use provisions and remove outdated institutional references—reflecting a push for stronger, more responsive regulatory governance in the health sector.

• 2025-03-25 03:01:27

Effective March 1, 2025, all medical device advertisement applications must be submitted exclusively through the online Google Form platform. This transition is designed to enhance operational efficiency, simplify the submission process, and provide a smoother, more user-friendly experience for all applicants.

• 2025-03-25 10:37:19

The Thai FDA updated its change notification guidelines, effective 15 January 2025, focusing on model additions/removals and importer/manufacturer info updates for both IVD and non-IVD devices. The update allows modifications to groupings when adding or removing products within the same application. Additionally, adding models is now classified as a Major Change, requiring an extensive documentation.

• 2025-03-10 02:22:15

Join Qualtech's webinar on March 26, 2025, for key insights into Australia's medical device market and TGA regulations. Learn about the registration process, Sponsor responsibilities, post-market requirements, and get answers to common questions. Register now here to secure your spot!