This region presents a versatile regulation space.  Japan is considered as one of the most difficult markets to practice medical and IVD device registration. Strict regulatory requirements, need for inspections when higher risk device are concerned, high cost of the process and the relatively long time to complete the registration process makes Japan a regulatory challenge for any expert.

The South Korean process is moderate and provides access to the market through the prostration of a technical file resembling the US FDA 510K submission coupled with lab test reports.  The full process is completed once a Product License, Device Business License and KGMP Certification are achieved.

On the contrary, there are no medical device regulations imposed in New Zealand other than the responsibility of the person marketing the device to ensure the device has either been approved by the US FDA or the EU with CE mark.