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New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, industry experts say. Read More
Canadian devicemakers are praising their government’s plan to implement an internationally harmonized system of unique device identification, but say it must become “truly global” to avoid additional barriers to trade. Read More
The U.S. Food and Drug Administration’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
The U.S., Canada, Australia and Brazil were supposed to begin shared audits in June under the International Medical Device Regulators Forum’s medical device single audit program. Read More
As of April, EU member states and the European Commission had conducted five mandatory joint assessments of notified bodies, with one resulting in a negative decision, according to a working document prepared by Commission staff and presented to the Council of the European Union. Read More
For the first time, manufacturers submitting 510(k)s would have to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More
Ventlab has received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, an industry observer says. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More