ASEAN

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers. 

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.

Digital data capture is rife now in the medtech sector. What needs to be done at an international level to control and optimize its use and that of real-world evidence based on this data? Do initiatives that came up at the International Medical Device Regulators Forum offer solutions to prevent potential global chaos?

Rising Leader Jing Lim is part of the team getting 3D implant and bone regenerating innovator Osteopore better known outside its founding base in Singapore. The company stands on the cusp of accelerated growth on the back of an expanding portfolio and its best practice approach to business building.

Governments in the ASEAN bloc continue to build national digital health roadmaps, which Siemens Healthineers’ local head of digitalization Virginia Chan sees as encouraging from many standpoints.

Vietnam’s medtech industry breathed more easily when the new decree, 98/2021, became the regulatory instrument for the sector on 1 January. While its practical approach to industry’s needs was welcomed, new price and profit declaration demands will be harder for companies to swallow.

Singapore is already deeply involved in “commercial” regulatory affairs, but it has the potential to increase the volume of “technical” RA work done locally. So says regulatory professional Jing Lim, who explained these definitions to Medtech Insight.

It has been a hard 18 months for those who rely on networking, gatherings and the personal touch to secure new business and ongoing customer loyalty. The ABHI’s Paul Benton explains how UK medtech has maintained a high profile globally in uncertain times.

The EU Medical Device Regulation will have impacts in countries beyond the EU27, a fact that is keeping MedTech Europe’s international team very busy.