EMERGO SUMMARY OF KEY POINTS:
- Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices.
- The Draft guidance will cover Class III and Class IV 3D-printed devices.
- Publication expected in fall 2018.
Canadian medical device market regulator Health Canada plans to publish new draft guidance on Medical Device Licensing (MDL) for 3D-printed devices in the near future.
In a new notice, Health Canada states that 3D-printed devices are generally subject to the same pre- and post-market regulatory requirements as other devices; specific guidance for these devices is necessary, however, due to issues related to additive manufacturing processes…