產品安全與行銷標示-明基材料 ESG

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環境永續

盡責產品

產品安全與行銷標示

盡責產品

SDGs

盡責產品

確保產品之設計、製造、品管與出貨皆能達到客戶期望，所有產品皆能符合各國之相關產品（如醫材）安全與標示規範並持續創新以協同客戶開發創新與永續之科技產品，持續減少有機溶劑之使用及降低廢棄物。

核心技術與智財管理產品創新與永續設計綠色運籌化學品管理產品安全與行銷標示

明基材料銷售之各項醫療器材產品，在出口至各國進行銷售前，皆須取得各銷售區域所在國之國家規定與認證，目前已取得之認證涵蓋台灣TFDA、歐盟CE、美國FDA、中國CFDA等，各國產品認證。

國家	產品適用法規
馬來西亞	Laws of Malaysia Act 737 Medical Device Act 2012
泰國	Medical Device Act, B.E. 2551 (2008)
印尼	Law on Health (Law No. 36/2009) Permenkes No. 62 Year 2017
越南	第36/2016/ND-CP號「有關醫療器材管理議定(DECREE on Medical Equipment Management)」第169/2018/ND-CP號「修正第36/2016/ND-CP號有關醫療器材管理議定(DECREE on Amendments to the Government’s Decree 36/2016/ND-CP dated May 15, 2016 on Medical Equipment Management )」第42/2016/TT-BYT號「有關承認醫療器材分類結果公告(CIRCULAR on Recognition of Medical Device Classification Results)」第39/2016/TT-BYT號「有關醫療器材分類公告(CIRCULAR on Classification of Medical Device)」
菲律賓	Republic Act No. 9711.《AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF.》 Republic Act No. 3720.《AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.》
西班牙	MDR

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