To increase access examination involved in the diagnosis of SARS infection (COVID -19 Antigen self-test kits), Thai FDA announced to unlock and embrace the online selling of COVID -19 Antigen Self-Test Kits.
More A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.
More To protect human health and the environment from Persistent Organic Pollutants (POPs), Thai FDA agreed to abide by the Stockholm Convention. In order to establish control measures, they conducted a survey of products/manufacturing processes that utilize perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, and benzyl cyanide.
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On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.
More Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.
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One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.
More Thai FDA alerted Medical Device Establishment concerning labeling and device document implementation applicable for all 4 classifications; Licensed Medical Device (Class 4), Notified Medical Device (Class 3+2), and Listing (Class 1). This remarkable movement is aiming to ensure consumer safety while practicing device traceability during post-market surveillance.
More Indonesia’s Ministry of Health has introduced simplified routes for certain class A medical devices. The characteristics of certain class A medical devices themselves are Home Use, Non-Sterile, and non-IVD. The products which can be registered through a simplified route will need fewer documentation requirements compared to the regular registration route.
More On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.
More Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.
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