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11.0 Analytical specificity: (i) This section should describe interference and cross react...

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Information required to be submitted for the in vitro diagnostic medical device: (1) The ...

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Analytical specificity: (i) This section should describe interference and cross reactivity...

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Proposed instructions for use or electronic instructions for use and labels.] (b) Data to ...

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(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of eval...

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22.0 Information required to be submitted for the in vitro diagnostic medical device: (1) ...

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PROVIDED that no fee shall be required to be paid by the institutes, organisation, hospit...

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INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFACTURE ...

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The information required under sub-rule (2) shall contain the following, namely:— (i) app...

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