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.
More 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 Therapeutic Goods Administration (TGA) has announced to establish an Australian Unique Device Identification (UDI) in October 2020 and has published new regulations on the approval and use of medical devices. These new regulations created a thorough database for the traceability of medical devices based on the UDI and the adverse event system.
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 01, 04, 07-10, 19, as well as 21 of the Category of Medical Devices.
More The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".
More 18 medical device industry standards have been approved and are now published. The number, name, scope of standards and date of implementation can be found in the attachment.
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China’s medical device market has continued to increase over the last years due to the rapid pace of technology and innovation, increase on its aging population, and demands for better healthcare services in the wake of the COVID-19 pandemic. Given the said market growth rate, plenty of opportunities are available for foreign companies to grab and make profits from the situation. In this article, the changes in the Chinese medical device market and factors to be considered by foreign manufacturer in entering the market will be explored.
More According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.
More 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.
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