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 MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.
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Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.
More Recently, MOH has introduced regulations for a total of seventeen COVID-19-related medical device categories, along with their submission dossiers and routes. Specifically, there are seven selective cases that can applied for fast approval. This circular also includes regulation on Import of medical device in view of COVID-19 prevention for purposes of aid.
More More than 100 administrative procedures under management of the Ministry of Health have been reduced and simplified with a recently introduced regulation. One of these is to convert Import Permit number to Registration number and to amend requirement on application for fast approval from 2 CFS to 1 CFS.
More Effective from June 17, 2021, MDA now allows multiple authorized representatives for each medical device (brand name) placed in the market. On the other hand, they will restrict to requiring individual establishment licenses to carry out role/activity of various economic operators, as prescribed in the Medical Device Regulations 2012.
MDA Circular Letter No. 1/2014 contains two components, which are the establishment that acts as an authorized representative (AR) and the establishment that carries out various activities.
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