Market entry support across twelve jurisdictions worldwide
International product registration in twelve markets under a single mandate. We submit to FDA (510(k), De Novo, PMA), ANVISA, NMPA, PMDA, MFDS, TGA and other competent authorities — covering Europe, Australia, Brazil, Canada, China, Israel, Japan, Korea, Saudi Arabia, Singapore, the UAE and the USA. Local agents, in-country representatives and license-holders are appointed through our partner network. You stay in contact with one MT Promedt project lead and get one consolidated timeline for the board.
Coverage across 12 jurisdictions
Local regulatory representation in every market where your devices are sold.
United States
M Squared Associates
Canada
North America regional partner
Brazil & LATAM
MANDALA International
Israel
L.S Marketing & Registration
Saudi Arabia & UAE
Medical Regulations Gate
China
CODEX Professional Translations
China
CRCS · NMPA
Taiwan · Asia-Pacific
Qualtech
Korea
Stendard
Japan
Kawasaki Legal Services
Singapore & Malaysia
CubicPharma
Australia
Brandwood Biomedical
Your questions about international registration
EU (MDR / IVDR), UK (MHRA), Switzerland (CH-REP), USA (FDA 510(k), De Novo, PMA), Brazil (ANVISA), China (NMPA), South Korea (MFDS), Japan (PMDA), Australia (TGA) and more — through our global partner network across twelve jurisdictions.
Non-EU markets are handled through our local regulatory partners under one MT Promedt mandate. You sign one contract; we coordinate the local agents, submission timing, and documentation.
At minimum: technical file or 510(k) summary, EU Declaration of Conformity, CE certificate (where applicable), ISO 13485 certificate, labelling, IFU, and country-specific forms. We provide a per-country checklist at the start of every project.
Highly market-dependent. FDA 510(k) typically 3–6 months; ANVISA 6–12 months; NMPA 12–24 months for higher-risk devices. Realistic timelines come after a dossier review.
Yes — medical devices Class I through III, IVDs Class A through D. Higher-risk classes typically require more documentation and longer review cycles.
Through our partner network we appoint local agents (e.g., US Agent, ANVISA BRH, Japanese DMAH, Korean MFDS holder) under a single MT Promedt service contract.
Download our Product Registration brochure
Service brochure
International Product Registration — English
International Product Registration — German
Need to register your device in another market?
From Europe to Asia-Pacific — get a tailored quote for any of our 12 jurisdictions within 24 hours, all under one contract.