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According to CDSCO guidelines, Fistula-repair biomatrix implant falls under Risk Class D under Gastroenterology category of Medical Devices. Intended use - A sterile, bioabsorbable, animal-derived substance intended to be injected into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue.. This article will give you complete information about manufacturing Fistula-repair biomatrix implant