At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese and South Korean regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics.
Japan recently adopted its “Sakigake” pathway for breakthrough biologics that allows for provisional approval based on limited clinical data, and it is considering a similar pathway for devices. The new device pathway would need to be approved by legislation.
The proposal would allow for rapid practical use of needed devices “based on the premise of ensuring safety,” Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) said. Such a system would use patient registries or similar electronic tracking for enhanced postmarket surveillance.
Similar to the Sakigake classification for drugs, it would require that an innovative device or in vitro diagnostic represents an urgent medical need and the premarket application would have to be the first in the world.
Once the pathway is designated, the devicemaker would receive a priority consultation, and the review time would be six months instead of 12 months.
Also at the meeting, South Korean officials discussed plans to introduce a unique device identification system and an enhanced adverse event portal that’s already in place.
The UDI system will be introduced in stages, starting with highest-risk Class IV devices in July. Class III devices will come online in July 2020, Class II in July 2021, and Class I in July 2022.
As with Japan, South Korea’s focus is on getting innovative devices and diagnostics to patients faster while also securing the supply chain.
Read the PMDA presentation here: www.fdanews.com/06-06-19-Japan.pdf.
Read South Korea’s presentation here: www.fdanews.com/06-06-19-SouthKorea.pdf.