The MedTech industry in Asia Pacific (APAC) as a region is different from the US and EU in several ways. To be successful in the region, it is important to take into consideration the following differences in your strategy.
- Diversity
APAC is a mosaic of countries, each with its own regulatory authority, laws, timelines, and submission requirement – including the need for translations. The various regulatory bodies vary in terms of sophistication and maturity, and many are still evolving. Language and culture play a big part in managing the submission process in areas such as labelling, IFU and compliance.
- Emerging Harmonisation
While fragmented, there is a trend towards regulatory harmonization notably in ASEAN. For more than a decade, ASEAN countries have worked to harmonize the regulations in MedTech, but each member country still has to account for its local laws and regulation.
- Digital Health and AI
There is also a rapidly evolving framework among different regulatory bodies in digital and AI. If your product includes digital software or AI, it is important to understand that there are efforts underway among regulatory bodies in APAC to keep pace with innovation.
- Beyond Regulatory Approval
Reimbursement in major countries such as Japan and Korea has to be considered as a strategic part of market entry. Regulatory approval is just the first step and has to be approached with the objective of gaining a high level of reimbursement involving an thoughtful approach in health technology assessment (HTA).