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Ensuring efficient implementation of EU device regulations is a key activity the UK’s Medicines and Healthcare products Regulatory Agency has tasked for itself over the next year, according to a new business plan. Read More
The House Committee on Rules is scheduled to meet Wednesday to consider amendments to the 21st Century Cures Act ahead of an expected vote in the full chamber. Read More
Devicemakers seeking to market their products in Malaysia must submit a declaration of conformity with the country’s medical device requirements, including certification of their quality management system and a list of applicable standards, according to draft guidance issued in June. Read More
The FDA is clarifying language related to the direct marking of medical devices for unique device identification purposes, including the definition of reprocessing. Read More
A panel of experts is calling on the Australian government to establish three new approval pathways for medium- and high-risk medical devices and align with the EU regulatory framework to expedite listing on the Australian Register of Therapeutic Goods. Read More