ROOM 301, 3RD FLOOR, BUILDING 1, NO. 16 BAOSHEN SOUTH STREET
ZHONGGUANCUN SCIENCE AND TECHNOLOGY PARK DAXING BIOLOGICAL PHARMACEUTICAL INDUSTRY BASE, DAXING DISTRICT
102609 BEIJING
CHINE
a)check the conformity of the devices in accordance with the quality management system under which the devices are manufactured before a device is released;
b)draw up and keep up-to-date the technical documentation and the EU declaration of conformity;
c)fulfil the post-market surveillance in accordance with Article 10(10);
d)fulfil the reporting obligations referred to in Articles 87 to 91;
e)issue the statement referred to in Sec 4.1 of Chapter II of Annex XV for investigational devices.