ANVISA Gap Analysis — Brazil
€149.00A scored Excel workbook that measures your device file against every ANVISA requirement and tells you, in one verdict, whether it is ready to file.
Showing all 6 results
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Sale!
Full Brazil Market Access Kit
Original price was: €487.00.€399.00Current price is: €399.00.Everything you need to prepare an ANVISA submission — the gap analysis, the essential requirements checklist and the technical dossier pack — in one download, at a saving.
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Sale!
Full India Market Access Kit
Original price was: €398.00.€349.00Current price is: €349.00.The India toolkit in one download — the CDSCO gap analysis plus the Device and Plant Master File templates — at a saving.
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Sale!
Full Saudi Arabia Market Access Kit
Original price was: €398.00.€349.00Current price is: €349.00.The Saudi Arabia toolkit in one download — the SFDA gap analysis plus the Annex 3 technical documentation kit — at a saving.
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India CDSCO Gap Analysis
€149.00A scored Excel workbook measuring your device file against India’s Medical Device Rules 2017 (CDSCO), with a filing-gate verdict.
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SFDA Saudi Gap Analysis
€149.00A scored Excel workbook measuring your device file against the SFDA’s Medical Device Marketing Authorization requirements (MDMA Saudi Route), with a filing-gate verdict.
