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根據南非國家法律規(guī)定，醫(yī)療器械產品出口到南非必須要經過南非國家健康藥品管理局注冊認證，且要同時獲得Sales Permit方可在南非市場銷售。

在南非醫(yī)療器械法規(guī)中，按照風險等級將醫(yī)療器械分為以下四類：

? Class A - Low Risk

? Class B - Low-moderate Risk

? Class C - Moderate-highRisk

? Class D - HighRisk

其中，醫(yī)用口罩適用標準是SANS1866-1/2，劃分為Class A。一般情況下，MCC/SAHPRA認證都是直接簽發(fā)給你南非經銷商或者南非代理。

西測國際認證檢測中心在南非設有分公司，可以為中國口罩企業(yè)申請南非認證提供當地代理人服務（Authorized Representative）。以下是Authorized Representative的要求：

“authorised representative” means any natural person, resident in the Republic of South Africa, who

a) has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic;

b) acts on behalf of a manufacturer, importer, distributor, wholesaler, retailer or service provider for specified tasks with regard to the latter’s obligations and in whose name the manufacturer licence, distributor licence, wholesaler licence and or certificate of registration is issued; and

c) is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration, clinical trials or clinical investigations;

MCC/SAHPRA認證主要需要以下資料：

? Full Name of legal person

? Company Registration Number or Individual Person’s IdentityNumber

? Physical address

? Postal address

? Telephone Number

? Nature of business activities: manufacture; importation; distribution; wholesaler or exportation

? Authorised Representative’s Name

? Authorised Representative’s work telephone number and mobile telephone number

? Authorised Representative’s email address