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医疗器械是一种特殊商品,因为它直接用于人体,必须保证其安全性和有效性。为此,国家医药管理局及各省市医药管理局(总公司)对在产产品进行了整顿与登记,并按规定颁发了相应的登记号。凡取得了登记号的医疗器械产品即为准予生产和销售,可以进入市场。凡流入市场,又未取得登记号的,一律视为假冒伪劣产
Medical devices are a special commodity because they are used directly in the human body and must be guaranteed to be safe and effective. For this purpose, the State Administration of Pharmacy and the provincial and municipal pharmaceutical administrations (head offices) have rectified and registered their products, and issued corresponding registration numbers as required. All medical device products that have obtained the registration number are allowed to be produced and sold, and can enter the market. All those who have entered the market and have not obtained the registration number shall be treated as fake and inferior products.