MicroPort Urocare (Jiaxing) Co.,Ltd.

1.Ensure to maintain and improve quality management system. Before the release, ensure the conformity of the devices is appropriately checked. Ensure PMS obligations and reporting obligations are fulfilled according to MDR. 2.For the case of investigational devices, the statement referred to in seciton 4.1 of Chapter II of Annex XV is issued, according to MDR.

1. Ensure that the company establishes, records, implements and maintains the latest and continuously improved quality management system, meet the requirements of laws and regulations. 2. Ensure that the post listing regulatory obligations comply with the provisions of Article 10 (10) of the MDR. 3. Perform the reporting obligations of Article 87, Article 88, Article 89 and Article 90 in the MDR.