The present invention provides a medical device and a manufacturing method thereof. The medical device comprises a biomedical metal layer and a polymeric film layer, wherein the polymeric film layer is made of a transparent polymer material. The manufacturing method comprises the following steps: providing a biomedical metal layer, dipping the biomedical metal layer into a polymer solution to form a polymeric film wrapped biomedical metal layer, and performing a reinforcing process to the polymeric film layer of the polymeric film biomedical metal layer to form a medical device. The transparent polymeric film is a non-absorbable transparent polymer which can be silica gel, polymethylmethacrylate, or fluorine resin, or alternatively an absorbable transparent polymer, which can be chitosan, collagen, gelatin, or hyaluronic acid.本發明提供一種醫療器材與其製造方法,醫療器材包括有生醫金屬層與高分子膜層,高分子膜層為透明之高分子材料;製造方法包含下列步驟:提供生醫金屬層,將生醫金屬層浸入高分子溶液,形成包覆高分子膜層生醫金屬層,並將高分子膜層生醫金屬層之高分子膜層進行強化程序製成醫療器材。S100~S300...流程步驟