A medical device company spent 18 months and $2 million preparing to launch in Southeast Asia — despite already holding approvals in the US, EU, Japan, and Australia. They launched three years behind schedule anyway. The direct answer: every SEA market runs its own approval process, its own timeline, and its own ownership rules — there's no "ASEAN license" that clears all six at once. Singapore approves in 3–6 months; Vietnam can take 18–30. Budget country-specific timelines