• 2025-11-26 07:23:46

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

• 2025-11-10 07:33:05

Join Qualtech's upcoming webinar, "Southeast Asia Medical Device Compliance Update Series 2025 Part 2: Singapore, Malaysia & the Philippines", to gain valuable insights into three of ASEAN's most active and evolving medical device markets. This session will feature Qualtech's local regulatory experts, who will share the latest updates, policy trends, and compliance strategies across Singapore, Malaysia & the Philippines. Updates include current regulatory developments, harmonization efforts, and practical approaches to maintaining compliance while expanding in Southeast Asia.

• 2025-10-27 06:53:05

The Asia Pacific aesthetic devices market will grow from USD 5.0 billion in 2024 to USD 11.5 billion by 2032, driven by minimally invasive treatments, innovation, and medical tourism. Emerging trends in preventive care, home-use devices, and male aesthetics create diverse opportunities across China, Japan, South Korea, Thailand, and Vietnam. Manufacturers that adapt to local demand and regulations will capture this expanding market.

• 2025-10-14 06:38:43

Join Qualtech's free webinar "Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam" on October 28, 2025, to gain practical insights into 3 of ASEAN's fastest-growing medical device markets. Learn about key regulatory updates, compliance strategies, and market opportunities directly from Qualtech's local regulatory experts. Stay informed, compliant, and ready for growth in Southeast Asia.

• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-04-25 02:16:08

Asian medical tourism has grown in popularity in recent years. With a global market share of more than 35%, its market size is predicted to rise at a 15% annual rate. The world's population is aging and increasing wealthy at a rate that high-quality healthcare cannot keep up with. Patients are seeking cross-border healthcare for these reasons. Asian healthcare providers offer world-class medical facilities, highly skilled doctors and medical workers, and a wide range of treatments and procedures at affordable prices. In this article, we will therefore look at Asia's medical tourism business and provide a comprehensive guide.

• 2023-01-19 06:29:59

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

• 2022-06-30 11:51:47

Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.

• 2022-05-31 02:38:03

The COVID-19 epidemic has undoubtedly boosted the healthcare industry digitization worldwide. Personal medicine, telemedicine, genomics, and wearables are predicted to increase significantly over the next half decade thanks to artificial intelligence (AI), extended reality (XR), cloud computing, and the internet of things (IoT). In the face of this trend, there are several opportunities and problems particular to the Asian medical device industry. In this article, we examine the general situation of the Asian medical device industry as well as the Chinese, Japanese, and ASEAN markets in further detail.