China expands medical device MAH program

Several years after it piloted a MAH system for medical devices in 4 locations in China, the government is expanding the pilot to 21 provinces/municipalities. The expanded Medical Device Marketing Authorization Holder (MAH) program will offer scientists and pharmaceutical research and development institutions in 21 locations throughout the China market the opportunity to hold their own device product licenses.

MAH-designated parties can commercialize their device assets without having to become device manufacturers themselves in China. As marketing authorization holders, they can completely outsource the actual manufacturing to contract manufacturing organizations.