August 17, 2018

Health Canada Opens Consultation on ‘Pause the Clock’ Proposal

Health Canada is seeking feedback on its plan to “pause the clock” during reviews of medical devices under specific circumstances.

The mechanism would help sponsors meet review deadlines and clarify any issues that arise without incurring penalties. It would also help hold the department accountable only for the time it spends on a particular submission or application.

The mechanism would be implemented only for specific circumstances that would not normally arise under the review process.

For example, Health Canada would be able to pause the clock for medical device applications linked together that have different review times, or for a sponsor’s extension request. The department would also be able to pause the clock when it seeks advice from expert panels during reviews.

Malaysia Extends Device Labeling Deadline by Three Years

Malaysia’s Medical Device Authority is pushing back device labeling requirements to allow for a three-year transition period to give devicemakers more time to meet the new requirements.

Previously, a two-year transition period was to apply beginning in 2016. Manufacturers will now have until 2021 to meet the new labeling requirements, which were to be in effect beginning in 2018.

The Aug. 5 MDA notice said that existing labeling will apply during the transition period.

The new labeling requirements coincide with new device registration requirements for importing, exporting, or placing medical devices on the market (IDDM, March 28).

Australia Issues Update on AERs Attributed to Bayer’s Essure Device

Australia’s Therapeutic Goods Administration released an update on Bayers’s Essure contraceptive device, saying the agency received 59 adverse event reports relating to women implanted with the device since it was supplied in Australia in 1999 until Aug. 6.

TGA removed the device from the Australian Register of Therapeutic Goods on Feb. 9.

The AERs included changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation, migration of the device, and allergy/hypersensitivity or immune-type reactions. Surgery was required in some instances to remove the device, the TGA said.

The TGA said that although no new Essure devices were supplied for the Australian market after May 31, 2017, some devices were already in the supply chain and were used until they were recalled in August 2017. The device was not supplied again in Australia following the recall.

In September 2017, Bayer advised the TGA that it would not be seeking EU recertification for the device.