• 2024-03-01 08:09:48

With Indonesia currently strengthening their regulations on Telecommunication Equipment Testing and Certification (including telecommunication medical devices), a Decree from the Head of BBPPT No. 36/2024 has been published concerning the Guidelines for Testing Services conducted at BBPPT (en: Telecommunication Device Testing Center)

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

• 2024-03-01 05:58:09

Decision No. 04/QD-BYT dated January 2, 2024 of the Vietnam Ministry of Health assigning Conformity Assessment Bodies for evaluation of Common Submission Dossier Template.

• 2024-01-26 07:26:23

Reflecting on 2023, Qualtech experienced a dynamic and transformative year marked by regulatory webinars and the establishment of a new office in Korea. Amid challenges and celebrations, we fortified our commitment to excellence, setting the stage for continued growth and even greater achievements in the future. Join us in revisiting the highlights that shaped our journey.

• 2024-01-26 07:14:49

The NMPA has revised the Quality Management Standards for Medical Device Operation. This article summarized the critical points of the revision.

• 2024-01-26 06:58:53

This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.

• 2024-01-26 06:51:35

This guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.

• 2024-01-04 02:44:21

Join us on our upcoming webinar and don't miss this chance to get expert EU MDR insights in the registration of aesthetic-purpose devices. See you on January 25, 2024 at 5 PM Taipei Time (10 AM CET)!

• 2023-12-28 09:01:53

In this latest edition, we navigate the evolving landscape of medical device regulations, marked by progress and heightened vigilance. The improvement of technology and healthcare is making things better for patients, but it also needs careful supervision. Over the past year, global regulatory bodies have demonstrated adaptability, reinforcing frameworks to manage medical device registrations effectively.

This edition offers a concise analysis of the latest mandates, impending updates, and pivotal shifts for 2024, addressing the exchange between technological innovation and the mission to ensure global safety and efficacy.

• 2023-12-26 05:15:49

Qualtech's regional meeting united leaders from across ASEAN to collaborate, share knowledge, and shape the future of Qualtech in the region. The event focused on fostering unity, unwavering commitment to quality with ISO 13485 standards, and strategic planning for each country's unique needs. A cultural immersion tour of Chulalongkorn University provided inspiration and deeper understanding. The meeting concluded with a shared vision for the future of Qualtech in ASEAN.