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.
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Brazil Essential Requirements Checklist
€89.00The full set of ANVISA essential requirements (RDC 848/2024), each cross-referenced to the matching EU MDR GSPR so you can reuse your CE evidence.
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Brazil Technical Dossier Pack
€249.00A set of fill-in Word templates that build an ANVISA technical dossier on the IMDRF table of contents, plus a master index to keep it all straight.
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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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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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Saudi Arabia Technical Documentation Kit
€249.00A fill-in Word template that builds the SFDA technical documentation on the Annex 3 structure, with the essential-principles checklist embedded and GSPR-mapped, plus a README and master index.
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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.
