1.-自由销售证明

Certificate of Free Trade issued by the Competent Authority of the country of origin or exporter

2.-GMP证书或者ISO13485等能类似GMP的证书 

Cetificado of Good Manufacturing Practices of the Manufacturer issued by the National Authority of Pharmaceutical Products, Devices and Sanitary Products or document that accredits the compliance of the Quality Standard specific to the type of medical device Example: CE of the European Community, Standard ISO 13485 in force, FDA or others according to the level of risk

3.-技术报告

Technical report of the device

4.-技术研究和分析检测

Technical Studies and analytical checks

5.-灭菌验证

Validation report of the sterilization process in the case of medical device

6.-处理办法

Disposal method, when applicable

7.-包装和标签

Project of immediate labeling and immediate packaging

8.-按照ISO办法的风险管控报告

Management report of risk analysis, according to specific ISO standard

9.-根据ISO标准支持基本安全条件的技术信息

Technical information that supports the essential safety conditions according to ISO standard

10.说明书或活页

-Instruction Manual or insert

11.-描述符合安全要求的措施

Description of measures to comply with safety requirements