• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 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.

• 2023-03-27 09:59:19

This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.

• 2022-08-30 03:43:54

PFDA issues the updated regulation for Medical Radiation Devices that aims to provide guidelines for the importation of radiation devices used for both medical and non-medical applications in accordance to AO 2018-0002.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-06-29 01:29:59

Recently, software technology has made significant advances and has been used considerably more frequently for medical purposes. It can drive itself to infer a clinical judgment in addition to serving as a message informant. The number of software-based medical devices that are currently on the market has significantly increased as a result of such software improvements. Therefore, it is important to monitor patient safety appropriately.