Class 3 IVD production (PCR kit) need to pass which system certification, is ISO13485 or ISO15189 or both need?

Medical device manufacturers are generally ISO13485, or plus ISO9001, I am familiar with several IVD manufacturers are ISO13485 (+ISO9001), Shanghai Executive Biological, Beijing Jiuqiang, Lidman, Sichuan Mike, etc., ISO13485 is not mandatory certification, you can not certify that you want to do the certification to find the specific certification company consulting, TUV Southend, Rheinland, etc., domestic Beijing Huaguang

. Foreign TUV Süd, Rheinland, etc., the domestic Beijing Huaguang