Rise in reviews and recalls

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The TGA has significantly increased the number of post-market reviews of medical devices and product recalls rose sharply, according to its annual performance statistics report for 2016-17.

According to the report released earlier this week, the regulator received 242 conformity assessment applications for medical devices in 2016-17, down from 257 in the previous year. The number of approved applications rose from 187 to 204.

It took an average 129 days to process applications for new medical devices, down from 133 days in 2015-16, with the average time for variations rising from 93 to 114 days.

The report reveals a significant increase in the number of post-market reviews of medical devices. In 2016-17, the TGA conducted 396 post-market reviews, up from just 80 the year before. The number of completed reviews jumped from 83 to 239.

The number of medical device incident reports also jumped sharply, from 3,841 to 4,896. The number of completed reports rose 36 per cent, from 3,608 to 4,918, with another 380 still in progress.

The number of product recalls in 2016-17 rose from 40 to 70.