Passive medical devices
2021-03-25
海外认证
Overseas Certification
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经典案例
Classic Case
CE certification guidance
- Categories:欧盟CE
- Time of issue:2021-03-25 14:54:35
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Description:
Information
The "CE" mark is a product safety certification mark, which is regarded as a passport for manufacturers to open and enter the European market. All products affixed with the "CE" mark can be sold in the EU member states, thus realizing the free circulation of goods within the EU member states. In the EU market, the "CE" mark is a compulsory certification mark. Whether it is a medical device produced by an EU enterprise or a medical device produced in another country, if it is to be freely circulated in the EU market, it must be affixed with the "CE" mark. Indicates that the medical devices comply with the EU’s "Active Implantable Medical Device Directive" (AIMD 90/385/EEC), "Medical Device Directive" (MDD 93/42/EEC), and "In Vitro Diagnostic Device Directive" (IVD 98/79/ EC) basic requirements. This is a mandatory requirement of EU law on medical devices.
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Company Introduction
The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.
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Beijing Medical & Care Co. Ltd.