PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.
More In order for Thai FDA’s quality control to conquer approval certificate issuance ratio, Thai FDA respectively announced a new E-Submission procedures governing Listing Medical Device, Notified Medical Device, and Licensed Medical Device applications (with exemption of class 1 auto approval), which has been effective since 1st August 2022.
More Utilization of Remote Regulatory Assessments (RRA) as a critical examination of an FDA-regulated establishment and/or its records. FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.
More The Food and Drug Administration (FDA) established a new regulatory category for over-the-counter (OTC) hearing aids. The new policy will redefine OTC hearing aids and change the current rules as well as modify the obsolete old rules. FDA believes this method will ensure the OTC hearing aids with innovative technology provide reasonable safety and effectiveness, while promoting public health.
More The Vietnam Ministry of Health released Circular No. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.
More MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.
More HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.
More 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.
More The Malaysian Medical Device Authority (MDA) issued the Fifth Edition Guidance for Labeling on Registered Medical Devices. The document's goal is to provide manufacturers and authorized representatives with a guidance on the content of medical device labelling.
More Starting July 1, 2022, MDA fully implemented the Medical Device (Responsibility & Establishment) Regulations.
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