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The House Energy and Commerce Committee’s proposed legislation sets in motion an expedited pathway to speed access to breakthrough medical technologies. Read More
The China Food and Drug Administration has issued 90 industry standards – 14 mandatory and 76 recommended – covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
Ongoing Federal Trade Commission demands for more scientific information to back marketing claims may affect some devicemakers, experts said Tuesday at the Food & Drug Law institute in Washington, D.C. Read More
Effective July 1, devicemakers seeking to register products in Taiwan will need to have their quality system documents approved before submitting an application. Read More
The Centers for Medicare & Medicaid Services and U.S. FDA are establishing an interagency task force to address issues around the regulation of laboratory-developed tests, including LDT quality requirements. Read More
The U.S. FDA’s Center for Devices and Radiological Health is launching a public database of labeling for home use devices and is looking for devicemakers to help test it later this year. Read More
With a June 30 device registration deadline fast approaching, Malaysia’s Medical Device Authority has released more guidance for manufacturers working to list their products. Read More