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