PFDA issued FDA Circular No. 2022-003 that bans the production and all kinds of market exchanges, such as distribution, sale, and advertisement, for several mercury-added devices and related products for safety reasons.
More PFDA released a draft circular that provides the requirements for good storage and distribution practices for medical devices, to serve as guidelines for medical device establishments in the Philippines.
More The Medical Device Authority (MDA) published a guideline document to provide information and explanation to establishments on how to submit a re-registration of registered medical device applications in Malaysia. The document prescribes the requirements for re-registration of registered medical devices for medical device registration applications that are about to expire or have already expired.
More MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.
More China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 02, 03, 05, 06, 16, 18, as well as 20 of the Category of Medical Devices.
More The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.
More The Malaysia Medical Device Authority (MDA) released the 2nd Edition of Guidance on The Rules of Classification for General Medical Devices MDA/GD/0009 on May 9, 2022.
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 China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 11-15, 17, as well as 22 of the Category of Medical Devices.
More The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).
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