根据南非国家法律规定，医疗器械产品出口到南非必须要经过南非国家健康药品管理局注册认证，且要同时获得Sales Permit方可在南非市场销售。

在南非医疗器械法规中，按照风险等级将医疗器械分为以下四类：

• Class A - Low Risk

• Class B - Low-moderate Risk

• Class C - Moderate-highRisk

• Class D - HighRisk

其中，医用口罩适用标准是SANS1866-1/2，划分为Class A。一般情况下，MCC/SAHPRA认证都是直接签发给你南非经销商或者南非代理。

西测国际认证检测中心在南非设有分公司，可以为中国口罩企业申请南非认证提供当地代理人服务（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 perbance, quality, safety and compliance with conditions of registration, clinical trials or clinical investigations;

MCC/SAHPRA认证主要需要以下资料：

• 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 bephone number and mobile bephone number

• Authorised Representative’s email address