Medical Devices (includes In Vitro Diagnostics)
Many of the Asia Pacific (APAC) economies have harmonised regulations which adopt the same technical standards (e.g. ISO/IEC) and harmonised guidances (e.g.GHTF/AHWP/IMDRF) as have been adopted in the major international economies. This leads to a process of convergence as regulatory requirements across economies become more aligned over time.
The commonality of technical approach allows the recognition of prior international assessments for the purpose of abridging and expediting local reviews.
Convergence does not require identical laws and regulations. Decisions always remain local and sovereign. However prior assessments from respected international jurisdictions can be used as input to local decision making.
In this session we explore current harmonisation status across the Asia Pacific and consider two jurisdictions in detail:
• Indonesia, which has adopted a national framework broadly in line with the ASEAN Medical Device Directive, and
• Australia, which has for many years recognised CE marking as the basis for most TGA registrations, and more recently has extended this to introduce recognition of US, Japanese and Canadian decisions.
The presentations will also touch on updates and harmonization in other APAC economies.
The CE mark has long had particular currency as input to APAC regulatory decision making and the changes in the European MDR are causing many regulators across the region to revisit their approaches. The session will explore the specific impact of the MDR on APAC harmonisation.
Participants will learn about the underlying principles implementation of regulatory harmonisation and the real-world application across the Asia Pacific and the. This session will provide specific, current information on regulatory practices and opportunities for leverage of prior international approvals to gain registrations in the Asia Pacific.