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The Indian government is creating a dedicated authority to oversee the regulation and production of medical devices, taking the first steps to separate the sector from the nation’s pharmaceutical regulatory regime. Read More
Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. 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
The FDA slapped a warning letter on a California manufacturer of balloon catheters and inguinal hernia implants for not adequately evaluating complaints. Read More
The FDA issued a final order reclassifying nonroller-type cardiopulmonary and circulatory bypass blood pumps from Class III to Class II with special controls. Read More
The UK’s health care costs regulator is recommending against coverage of two new tests to help diagnose prostate cancer in people who have had a negative or inconclusive prostate biopsy, saying they aren’t an efficient use of government funds. Read More
India’s health ministry will soon roll out a program to collect and monitor adverse events involving medical devices, under the ongoing Pharmacovigilance Programme of India. Read More