Hong Kong pilots expedited approvals for some medical devices

A pilot program to streamline approvals of some medical devices will kick off this September, according to Hong Kong’s Medical Device Control Office (MDCO). Under the trial program, Class II, Class III and Class IV general medical devices will be eligible for inclusion in the expedited approval process. Only devices with proven safety and performance records will be eligible to participate in the program, which began September 1 and runs through June 30, 2020.

Interested applicants will need to complete an application available on the MDCO website and provide a device profile and supporting documentation.