Several months ago, the State Council began to work on setting up the pilot Beijing MAH system for medical devices. Shanghai, Shenzhen and Tianjin have already set up their own pilot MAH systems in 2017 and 2018. Prior to the implementation of these MAH systems, if a foreign device company has its own rep office in one of these cities but used a Chinese OEM to make their products for China, the China registrations could not be held in the foreign companies’ names – they would have to be held in the Chinese manufacturers name.
With the MAH system, if a foreign company sets up a legal entity in one of these 4 cities, and they utilize a Chinese OEM in that same city, the foreign company’s local office can act as the MAH and hold the registrations on their own – even though a Chinese OEM (in the same city as the foreign company’s local entity) has made the foreign company’s products. This provides lots more control to the foreign company and their ownership for their products that they are selling in China. It is predicted in the near future that more MAH systems will be set up in other China cities. This will give more foreign entities (that use local Chinese manufacturers) more control of their business in China.