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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
The FDA will need to change its approach if it wants to regulate genomic medicine while encouraging the field to grow, a special report in the New England Journal of Medicine concludes. Read More
The number of adverse events reported by devicemakers in Australia jumped by more than a thousand in 2014, compared with the previous year, regulators say. Read More
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say. Read More