There's a difference between manufacturer approval for the quality system and manufacturing site (via SGS) and product approval (on a per product basis for FDA and CFDA). However, SGS can approve the product for CE-Mark because the way the European Union have set up their Medical Device Directive.
You need product approval before being able to ship and sell into any region.
Ann: CE, FDA and CFDA Approval - Guangzhou Production Facility, page-276
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