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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
Manufacturers of tanning bed ultraviolet and sunlamps that were offered for sale prior to Sept. 2, 2014, must submit 510(k)s to the FDA by Aug. 26. Read More
Foreign entities may now own up to 100 percent of an established Indian devicemaker without first getting government approval, under revisions to the country’s consolidated foreign direct investment policy. Read More