Australia and South-East Asia are natural next steps for manufacturers already approved in Europe or the USA, as both lean on those approvals.
How we help
- Australia: TGA inclusion on the Australian Register of Therapeutic Goods, and Australian sponsor arrangements
- ASEAN: registrations in Malaysia, Singapore, Indonesia, Thailand, Vietnam and the Philippines under national rules based on the ASEAN Medical Device Directive
- Central and South Asia: Pakistan, Bangladesh, Sri Lanka and Central Asian registrations through our network
- Quality systems and technical files that work across all of these markets
Talk to us about Asia Pacific
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
