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Device Registration

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to place devices on the market. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

Medical device registration support across all major markets

With offices worldwide, Emergo has helped medical device and IVD companies register their products in over 55 markets. Our consultants provide device registration and regulatory compliance expertise in established markets such as the US, Europe and Japan as well as emerging markets including China, Brazil, India, and Mexico. We support medical device companies with their registration goals in the following markets:

Explore all device registration services.

Medical device and IVD market monitoring and registration tracking

Our consultants and project managers track regulatory changes in all markets where we operate, ensuring that your premarket application meets the most up-to-date requirements for US FDA 510(k) clearance, European CE Marking, Japanese PMDA approval and other market registrations. Using our Regulatory Affairs Management Suite (RAMS), our clients stay informed about relevant changes, avoid expirations, and manage registrations for their entire product line. Watch the video to explore the RAMS platform or visit the RAMS-Track website.

 

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Device Registration

Australia | Device Registration

澳大利亚TGA医疗器械注册

Brazil | Device Registration

巴西ANVISA医疗器械注册登记与审批

China | Device Registration

中国CFDA医疗器械注册登记与审批

Costa Rica | Device Registration

哥斯达黎加医疗器械注册登记与审批

Egypt | Device Registration

埃及医疗器械注册登记与审批

Europe | Device Registration

欧洲医疗器械CE标签策略

Europe | Device Registration

CE技术文件或设计材料编制与审核

Hong Kong | Device Registration

在香港的医疗器械注册登记

Israel | Device Registration

以色列医疗器械注册登记与审批

Malaysia | Device Registration

在马来西亚的医疗器械注册登记

New Zealand | Device Registration

新西兰的MedSafe医疗器械注册登记

Peru | Device Registration

秘鲁医疗器械注册登记与审批

Saudi Arabia | Device Registration

沙特阿拉伯的医疗器械注册登记与审批

Singapore | Device Registration

在新加坡的医疗器械注册登记与审批

Taiwan | Device Registration

台湾医疗器械注册登记与审批