With the continuing pandemic, PFDA relaxes its regulation for the manufacture of medical oxygen and the expiry of the special certifications for imported COVID-19 test kits. However, certain conditions must be met to be eligible for these exemption or extension.
More As we approach the end of the year, Thai FDA published a renewal guideline for licensed and notified medical device manufacturing and importation licenses that will be expired on 31 December 2021. To continue to engage in their respective activities, manufacturers and importers shall comply with this guideline within 1st October to 31st December 2021.
More With the implementation of Risk Classification under the new regulation, Thai FDA agreed to make an amendment to the evaluation expenses. The evaluation fee shall follow the new rates unless the applicant is eligible for a waiver or exemption.
More 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.
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