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秘鲁医疗器械注册要求
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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.-Technical information that supports the essential safety conditions according to ISO standard

10.-Instruction Manual or insert

11.-Description of measures to comply with safety requirements

 


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