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doesthe original model need to be implemented with the newstandard requirements?

医疗器械技术评审

If Change of Permission Items indicates addingof models, meanwhile new standards are involved,doesthe original model need to be implemented with the newstandard requirements?

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ku13145 二阶会员用户来自于: 广东省深圳市
2023-09-17 16:47

For instance, the registered models are A and B,and thenew models are C and D. Then, for the new models, they shall beimplemented with the requirements of the new standard, and thetesting report and/or verification/validation data shall be providedIf the original models A and B are not changed, then no relevantinformation is needed and new standard is not added into the ProductTechnical Requirements. Administrative counterparts shall ensurethat A and B can also meet the requirements of the new standardfrom the date of implementation of the new standard.If new standard is added into the Product TechnicalRequirements, testing reports and/or verification/validation data shallbe submitted to certify A and B could meet the modified ProductTechnical Requirements.

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发布时间: 2023-09-17 16:47

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