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Primary title |
Secondary title |
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Document 1: Application Form |
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Document 2: Letter of Authorization for Agent |
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Document 3: List of Basic Requirements for Safety and Effectiveness of Medical Device |
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Document 4: Overview |
Document 4.1 Executive Summary Document 4.2 Device Description Document 4.3 Catalogue/Model Document 4.4 Package Description Document 4.5 Indication and/or Intended Use and Contraindications Document 4.6 Reference to Similar and Previous Generations of the Device (if have) Document 4.7 Other description |
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Document 5 Research Documents |
Document 5.1 Performance Study Document 5.2 Biocompatibility Evaluation Study Document 5.3 Biological Safety Study Document 5.4 Sterilization and Disinfection Process Study Document 5.5 Shelf Life and Package Study Document 5.6 Animal Study Document 5.7 Software Study Document 5.8 Other Study |
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Document 6 Manufacturing Information |
Document 6.1 Manufacturing Processes Document 6.2 Design and Manufacturing Sites |
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Document 7 Clinical Evaluation |
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Document 8 Risk Analysis |
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Document 9 Product Specifications |
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Document 10 Registration Test Report |
Document 10.1 Test Report Document 10.2 Pre-evaluation Comments |
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Document 11 Instructions for Use and Label |
Document 11.1 Instructions for Use Document 11.2 Label of smallest trading unit |
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Document 12 Conformity Statement |
