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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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REGISTER NOW: To Err is Human: A Documentary Film Screening and Discussion on Preventing Human Errors in Medical Technology, Mar 7, 2019 to Mar 7, 2019 in Waltham, USA

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Device Registration

Australia | Device Registration

호주의 체외 진단기기(IVD) 등록

Australia | Device Registration

호주 TGA 의료기기 등록

China | Device Registration

중국 CFDA 의료기기 승인

Colombia | Device Registration

콜롬비아 의료기기 등록

Hong Kong | Device Registration

홍콩에서의 의료기기 등록

India | Device Registration

인도 의료기기 등록 및 승인

Japan | Device Registration

일본 PMDA 의료기기 승인 및 인증

Malaysia | Device Registration

말레이시아에서의 의료기기 등록

Mexico | Device Registration

멕시코에서의 의료기기 및 IVD 등록

New Zealand | Device Registration

뉴질랜드에서의 의료기기 등록

Peru | Device Registration

페루 의료기기 등록 및 승인

Russia | Device Registration

러시아 연방에서의 의료기기 등록

Saudi Arabia | Device Registration

사우디아라비아의 의료기기 등록 및 승인

Singapore | Device Registration

싱가포르에서의 의료기기 등록

South Korea | Device Registration

한국 KFDA 제출을 위한 기술문서 준비

South Korea | Device Registration

한국 MFDS 의료기기 등록 및 승인

Taiwan | Device Registration

대만에서의 의료기기 등록

United States | Device Registration

의료기기 FDA 510(k) 컨설팅