• 2026-03-20 06:20:35

Meet us at CMEF 2026 in Shanghai to explore full lifecycle compliance services, integrated clinical trial capabilities, and streamlined global registration solutions. With local regulatory connections and multidisciplinary expert support, we offer on-site consultation and personalized guidance.

Visit our booth and book a one-on-one session in advance to plan your market access strategy!

• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

• 2026-03-02 08:37:30

Celebrating 25 years of commitment and growth, Qualtech proudly reflects on the strength of our global offices and on-the-ground teams at the heart of our success. With consistent local execution across regions, we step into 2026 grounded in experience and strengthened by our international presence.

• 2026-03-02 02:28:47

Singapore's Smart Health initiative leverages technology to transform healthcare, addressing an aging population and driving demand for innovative medical devices. As a regional hub with high healthcare spending and import dependency, Singapore offers significant opportunities for med-tech companies focusing on digital health, AI, and assistive technologies. This article will highlight the insights for medical device businesses to leverage Singapore's Smart Health vision.

• 2026-02-26 08:25:34

The Malaysia Medical Device Authority (MDA) has officially gazetted the Medical Device (Designated Medical Device) Order 2026, effective on 1 June 2026. The Order involved medical device primarily used in aesthetic, therapeutic, and clinical settings. To enhance safety and mitigate risks, designated medical devices shall comply with Malaysian regulatory requirement for entering the Malaysian market.

• 2026-02-26 07:44:34

The Thai Food and Drug Administration (Thai FDA) and the Medical Device Authority (MDA) of Malaysia have initiated the Pilot Reliance Project, a joint effort to facilitate medical device registration by recognizing each othe's regulatory approvals. The pilot project is effective from February 2026 until 30 April 2026.

• 2026-02-25 04:43:48

Thai FDA has provided recommendations on applicable international standards for particular types of active medical devices to support medical device registration in Thailand. These standards are presented as advisory references only and are intended to assist the registrants in preparing relevant test reports in accordance with the ASEAN Common Submission Template Dossier (CSDT).

• 2026-02-25 04:14:57

The Ministry of Food and Drug Safety (MFDS) has amended the Regulation on Permission, Notification, Review, Etc. of Medical Devices, effective 26 January 2026. The revision expands acceptable clinical documentation, integrates Class II certification responsibilities, refines the regulatory framework for innovative medical devices, clarifies technical documentation requirements, and strengthens cybersecurity submission obligations for connected devices. These updates aim to enhance regulatory clarity, align with international standards, and improve the efficiency of approval and certification procedures in South Korea.

• 2026-02-25 03:48:52

PMDA recently released the revision for managing changes to raw materials used in medical devices. The revision clarifies the scope of minor change notifications that do not impact safety or performance and consolidates the criteria for determining applicability in low-risk cases or where sufficient prior usage experience exists.

• 2026-01-30 06:02:05

Vietnam faces a surge in respiratory diseases, primarily COPD and asthma. Heavy reliance on imported medical equipment exacerbates the issue. The government's Healthy Lung Program offers hope, but increased demand for respiratory devices creates a market opportunity.