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REGULATION OF MEDICAL DEVICE 4. Classification of medical devices (1) Medical devices othe...

2023-07-13T09:39:21

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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

2023-10-11T04:45:03

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3.8 Design output means the results of a design effort at each design phase and at the end...

2023-10-09T05:41:57

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3.6 Component means any raw material, substance, piece, part, software, firmware, labeling...

2023-10-09T05:41:06

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Procedure for disposal of confiscated medical device (1) The Court may refer the confiscat...

2023-08-10T05:38:34

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PROVIDED ALSO that, the results of clinical investigation may not be required ta be submit...

2023-08-05T05:11:25

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(b) a pivotal clinical investigation on an investigational medical device shall be made on...

2023-07-31T06:14:42

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REGISTRATION OF CERTAIN MEDICAL DEVICES 19A. (1) This Chapter shall be applicable to all d...

2023-07-18T04:40:19

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All relevant clinical and non-clinical safety data will cover only the period of the repor...

2023-07-08T06:02:56

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