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The FDA has handed Cenorin a warning letter for not reporting modifications to its Medical Device Cleaning and HLD Washer/Pasteurizer Model 610. Read More
Devicemakers that market products in Canada must certify their quality systems through the International Medical Device Regulators Forum’s single-audit program, beginning in 2017, regulators say. Read More
A years-long standoff between the U.S. FDA and Maquet ended with a consent decree calling for the devicemaker to improve quality at its three subsidiaries. Read More
The China Food and Drug Administration plans to revise its device good manufacturing practices to include specific GMPs for sterile and implantable devices. The revisions, outlined in a Feb. 9 draft guidance, aim to bring GMPs for these products up to par with international standards, Seth Goldenberg, director of global regulatory strategy at NAMSA, tells GMP. Read More
TreyMed, a contract manufacturer of sensors, received a warning letter from the U.S. FDA after modifying entries in its inspection data record for parts that resulted in failures. Read More
Topspins, a specification developer and own-label distributor of IV tubing sets, was warned by the U.S. FDA after making design changes without appropriate validation. Read More
Failure to give the FDA a written report of a correction made to its Point-of-Care Unit, an infusion therapy delivery device, resulted in a Form 483 for CareFusion 303. Read More
Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
Failure to adequately establish requirements that must be met by suppliers, contractors and consultants resulted in a Form 483 for Steris following a July 14 inspection. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
The China Food and Drug Administration plans to beef up its inspections system for medical devicemakers by adding more investigators and improving the performance of quality testing centers. Read More