Global Coverage
Regulatory pathways, market by market.
Built-in expertise across major regulatory authorities, integrated with in-country representation and lifecycle support.
United States — FDA
U.S. Food & Drug Administration
510(k), De Novo, PMA, and Q-Submission strategy with UDI and post-market reporting.
Explore pathwayEuropean Union — MDR
EU Medical Device Regulation 2017/745
MDR technical documentation, Clinical Evaluation, PMS/PMCF, and Notified Body strategy.
Explore pathwayUnited Kingdom — MHRA
Medicines & Healthcare products Regulatory Agency
UKCA marking pathway, UK Responsible Person, and MHRA device registration.
Explore pathwayCanada — Health Canada
Health Canada — Medical Devices Directorate
MDL/MDEL licensing supported by MDSAP-aligned quality documentation.
Explore pathwayAustralia — TGA
Therapeutic Goods Administration
ARTG inclusion, Australian sponsor coordination, and conformity assessment support.
Explore pathwayJapan — PMDA
Pharmaceuticals & Medical Devices Agency
Shonin/Ninsho approval strategy, Marketing Authorisation Holder support, and JGMP alignment.
Explore pathwayChina — NMPA
National Medical Products Administration
NMPA registration strategy, type testing coordination, and local agent representation.
Explore pathwaySaudi Arabia — SFDA
Saudi Food & Drug Authority
MDMA licensing, GCC market access, and Authorised Representative services.
Explore pathwayIndia — CDSCO
Central Drugs Standard Control Organisation
Medical device registration, import licensing, and Indian Authorised Agent representation.
Explore pathwayGet Started
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