The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.
More MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.
More MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.
More Recently, software technology has made significant advances and has been used considerably more frequently for medical purposes. It can drive itself to infer a clinical judgment in addition to serving as a message informant. The number of software-based medical devices that are currently on the market has significantly increased as a result of such software improvements. Therefore, it is important to monitor patient safety appropriately.
More PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.
More NMPA has issued a new regulation of the “Management Provision on the Self-Testing for Medical Device Registration” which include the requirements for manufacturer’s capacity for self-testing, quality management system, self-testing report and related responsibilities.
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2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.
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 This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.
More Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.
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