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With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, raising concerns that companies won’t be prepared to market their products in the country. Read More
Devicemakers are breathing a collective sigh of relief following the Indian government’s decision to let companies affix labels with India-specific information on their products after they enter the country. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14. Read More
Devicemakers seeking authorization to market Class II products in Canada will have to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More
Devicemakers are urging the incoming president of the European Commission to clarify once and for all whether medical technologies will continue to be overseen by the directorate for health or move to industry, as previously proposed. Read More
The International Medical Device Regulators Forum is seeking feedback on a proposed plan to share adverse event reports among national regulatory authorities.
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Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The U.S. Food and Drug Administration last month unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
The Australia government plans to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators as part of a broad effort to streamline the country’s device approval process. Read More
Three months after the EU’s RoHS 2 deadline, Stryker has reviewed more than 600 products and dealt with “significant” costs to comply with the regulations. Fortunately, the company has had a relatively easy time finding alternative components when necessary. Read More
Devicemakers need to be vigilant against possible embedded medical device software vulnerabilities as the FDA continues to develop a formal cybersecurity strategy, a security expert warns. Read More
Devicemakers are urging the incoming president of the European Commission to clarify once and for all whether medical technologies will continue to be overseen by the directorate for health or move to industry, as previously proposed. Read More