In August, the Malay Medical Device Authority (MDA) issued a guidance document outlining the Association of Southeast Asian Nations (ASEAN) harmonized list of medical devices. This list includes over 250 devices and also classifies the devices (A, B, C, and D) in... Read More
On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More
Under draft rules released in January by the Philippines Food and Drug Administration (FDA), all in-vitro medical devices (IVDs) imported, marketed, or manufactured in the archipelago nation will soon for the first time be required to be registered with health authorities in... Read More
Medical devices already approved for sale in Association of Southeast Asian Nations (ASEAN) countries may be eligible for fast-track access to the Philippines market, according to a directive issued in November by the Philippines Food and Drug Administration. Since February, Philippines regulatory... Read More
Licenses to sell medical devices in Thailand will be more difficult to obtain under a rigorous new system of regulations issued in February by the Food and Drug Administration of the Southeast Asian country. The new rules are in line with the... Read More
Moving to align its system for approving the sale of medical devices with those of other Association of Southeast Asian Nations (ASEAN) countries, the Philippines Food and Drug Administration in February announced new requirements for registering and regulating such products. The new... Read More
With the COVID-19 pandemic bringing into focus the need for better collection and use of data in healthcare, health authorities in Vietnam are pushing to accelerate the development of artificial intelligence platform and technologies. In June, the Ministry of Health announced an... Read More
Medical devices may not be promoted or advertised to healthcare professionals or institutions in Thailand without permission from appropriate regulatory authorities, according to a directive issued in November by the Thai Food and Drug Authority. The guidelines on direct advertising were among... Read More
Some medical devices already registered for sale in two of the five countries including Australia, Canada, the European Union, Japan or the United States for over one year that have not had serious adverse events will be eligible for quicker approval in... Read More