REGISTRATION DOSSIER PREPARATION & LICENSING HOLDING SERVICES
Regulatory Access to the Vietnam Market
Labomed supports global medical device and pharmaceutical manufacturers with end-to-end regulatory dossier preparation and licensing holding services, enabling legal market entry and sustained regulatory compliance in Vietnam.
Regulatory access
End-to-end preparation, submission, and follow-up of product registration dossiers in full compliance with Vietnam Ministry of Health regulations
License holding
Labomed acts as the authorized local license holder for foreign manufacturers without local incorporation in Vietnam
Lifecycle compliance
Ongoing license management, amendments, renewals, and continuous regulatory monitoring throughout the product lifecycle
Value for Foreign Partners
Full market control
Manufacturers can flexibly add, change, or replace distributors/importers without re-registration or license transfer
Faster & simpler execution
No repeated authorization letters, consular legalization, or waiting for new partners to complete registration procedures
Cost-efficient model
Fees paid to Labomed can be allocated per shipment and recovered from importers, while manufacturers retain long-term regulatory ownership and market control
