• 2026-10-09 01:44:32

Qualtech invites you to our free webinar on Thursday, October 29, 2026, with the topic "ASEAN Regulatory Briefing: Thailand & Malaysia - Critical Updates Impacting Medical Device Market Access".
Our local regulatory experts from Thailand and Malaysia will share practical insights into the latest regulatory changes, updated requirements, and key considerations affecting medical device registration and regulatory compliance. This session is highly recommended for all medical device manufacturers currently active in, or planning to enter, the Thailand and Malaysian market.

• 2026-09-23 03:31:24

Staying connected with the industry helps Qualtech keep its market knowledge current. Through our participation in CMEF Shanghai and BIO Asia–Taiwan 2026, we exchanged perspectives with manufacturers and industry professionals on market trends, regional expansion, and regulatory considerations across APAC.

• 2026-09-21 02:42:09

The Department of Health (DH) of Hong Kong issued a letter regarding the updated regulatory requirements for the use of injectable and infusible product in licensed Private Healthcare Facilities (PHFs) which cover pharmaceutical products, human organ/human tissue product, and medical device. For medical devices, the DH has announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the MDACS, effective 1 March 2027. This new requirement specifically includes injectable dermal fillers and injectable mucous membrane fillers.

• 2026-08-25 04:02:15

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

• 2026-08-25 04:50:05

Indonesia's medical device regulatory framework places increasing emphasis on demonstrating compliance with applicable healthcare standards through appropriate testing and validation. Manufacturers and applicants should ensure that the required test results, validation documents, and supporting certifications are available as part of the product registration and compliance process. Recent requirements highlighted for in vitro diagnostic products (IVDs) include specific provisions for performance testing, instrument connectivity, and software validation.

• 2026-08-25 04:38:17

The Hong Kong Department of Health (DH), through its Medical Device Division (MDD), has established the "Novo Lane" under the Medical Device Administrative Control System (MDACS) to prioritize the processing of eligible innovative medical device listing applications. The initiative is intended to facilitate earlier access to innovative medical technologies while maintaining regulatory oversight of medical device safety and performance. As part of its regulatory approach, the MDD continues to monitor the safety and performance of listed medical devices after they are placed on the market.

• 2026-07-27 04:05:50

Qualtech's recent webinar provided practical insights into medical device market entry in Australia and New Zealand, covering Australia's ARTG inclusion process, post-market obligations, new UDI requirements, and New Zealand's WAND notification framework. The session also highlighted key regulatory updates and practical considerations for manufacturers planning expansion into the ANZ market.

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-07-27 02:48:38

The PMDA has issued a Q&A document providing practical guidance on the implementation of the Standards for Biological Raw Materials to ensure the quality and safety of pharmaceuticals, medical devices, and related products. The updated guidance addresses topics such as ensuring the reliability of donor screening and testing, the evaluation of prion clearance values, and considerations related to BSE risk status designations, thereby clarifying the latest operational approach to the Standards for Biological Raw Materials.

• 2026-06-26 06:49:48

Qualtech will be exhibiting at BIO Asia–Taiwan 2026, taking place from 16–19 July 2026 at the Taipei Nangang Exhibition Center, Taiwan. Visit us at Booth N1007 to connect with our regulatory and business development specialists and discuss medical device registration, regulatory compliance and market access opportunities across Asia Pacific.