https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/personal-protective-equipment_en

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如需投放市场产品，必须满足日本需求Pharmaceutical and Medical Device Act (PMD Act)，在PMD Act的要求下，TOROKU注册制度要求外国制造商必须走向PMDA注册制造商信息。