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e) a description of the accessories, other medical device and other product that are not m...

2023-09-14T04:56:32

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3. Premises and Facilities: (i) layout of premises with indication of scale; (ii) nature o...

2023-09-12T05:12:30

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Device description and product specification, including variants and accessories 2.1 The d...

2023-06-27T04:38:34

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Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) qualifi...

2023-06-26T07:13:36

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If the device contains any of the followings, then descriptive information on the follow...

2023-05-20T05:35:46

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7.3.3 Design and development outputs: The outputs of design and development shall be provi...

2023-10-13T05:19:00

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DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the following...

2023-07-10T08:57:56

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Design and development outputs: The outputs of design and development shall be provided in...

2023-07-05T05:23:37

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) Appendix: The appendix includes the copy of marketing authorization in India, copy of pr...

2023-05-29T09:20:16

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