• 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.

• 2026-01-30 07:13:08

Thailand has updated its medical device labeling and IFU regulation, which will take effect on June 20, 2026. The new regulations expand the scope to include Software as Medical Device (SaMD), reusable surgical and dental instruments, and medical device accessories. Manufacturers and Importers are granted transition period until June 20, 2028, to transition from the 2020 requirements to the new 2025 requirements. Medical device companies marketing products in Thailand must update their labeling and IFU to comply with this updated announcement by the enforcement deadline.

• 2026-01-30 05:41:43

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore's Health Sciences Authority (HSA) have created a first‑of‑its‑kind Regulatory Innovation Corridor, launched on 12 December 2025. This coordinated fast‑track pathway allows developers of breakthrough medicines and medical devices to engage both regulators simultaneously. By offering coordinated feedback early in development, it seeks to streamline clinical trials, reduce duplication and accelerate patient access to promising therapies in areas such as cancer, dementia, obesity, rare diseases and advanced diagnostics. Further detail on the new fast track pathway have not yet been published by HSA.

• 2026-01-30 04:39:59

Recently, in the tempu bunsho (Japanese approved IFU) of pharmaceuticals containing hydroxycarbamide as the active ingredient, a warning was issued that, when taking this drug, glucose measurement results may show values higher than the actual glucose level (false high values).
Accordingly, similar warnings should also be included in the tempu bunsho of blood glucose measuring devices. Therefore, for blood glucose measuring devices using the enzyme electrode method, a voluntary review of the tempu bunsho should be conducted, and, if necessary, revisions and dissemination of information to should be implemented.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.