• 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 The updates broaden emergency use provisions and remove outdated institutional references—reflecting a push for stronger, more responsive regulatory governance in the health sector.

• 2025-03-10 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!

• 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

• 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

• 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 03:13:13

On January 1st, 2025, the Vietnam Ministry of Health issued Decree No. 04/2025/NĐ-CP, extending the validity of import licenses for medical devices until June 30, 2025. This decree updates Clause 2, 3, and 4 of Article 76 in Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP. These changes aim to allow businesses to continue operations without interruption and ensure smooth operations in medical device management.

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-06-20 07:20:10

Considering expanding your medical device business to Brazil or Southeast Asia? Qualtech Consulting Corporation's recent webinar can help! This informative session explored navigating the regulatory landscapes in these rapidly growing markets.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2024-05-02 01:55:12

Join our FREE webinar on ASEAN Regulatory Updates & Brazil's Medical Device Regulations. Learn how to stay compliant and enter the Brazil market! Sign up today!