医疗器械注册登记

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. 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 50 countries. 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:

• Australia
• Brazil
• Canada
• China
• Colombia
• Costa Rica
• Europe
• Hong Kong
• India
• Israel
• Japan
• Malaysia
• Mexico
• New Zealand
• Peru
• Russia
• Saudi Arabia
• Singapore
• South Africa
• South Korea
• Taiwan
• United States

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. Explore the RAMS platform.