Check the local role and its eligibility
Local representation takes different forms. Malaysia’s MDA guidance identifies an authorised representative role for overseas manufacturers; Hong Kong’s voluntary MDACS framework uses a Local Responsible Person arrangement. These roles should not be assumed to have the same duties. Confirm the exact local scope, eligibility and authorisations.
Make the responsibilities explicit
As a partner-selection recommendation, document who holds the dossier, handles authority communications, maintains registrations and coordinates safety issues. Confirm the entity’s actual authorisations directly. A commercial introduction or advisory engagement does not establish regulatory eligibility.
Consider continuity from the start
We recommend agreeing how documentation access, communication and a future change of representative would work. Transfer and change arrangements must follow the relevant authority’s current rules. Contractual flexibility is valuable, but it cannot override local regulatory responsibilities.
Official sources
MDA — Establishment License Information ↗Hong Kong Medical Device Division — Frequently Asked Questions ↗Sources accessed on 14 November 2026. Planning recommendations are identified in the text. Requirements may change; confirm the current position with the relevant authority.