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In April, SGS experts met with the Medical Devices industry and influencers in Japan, Korea and Taiwan to share the latest updates on medical device regulations.

Education, we believe, is the key to successfully navigating the complexities of medical device regulations. Whether it is Chinese regulators easing market approvals via an online system, the EU and US FDA draft proposals for tightening of pre- and post-market surveillance respectively, or registrations in Russia being temporarily suspended – our focus is keeping you up-to-date, wherever in the world you operate.

Keeping up with Change

Medical devices is one of the world’s fastest growing industries. We realise that staying up-to-date on how to gain market access in specific regions, and other key global markets, is crucial to manufacturers. With this in mind, we have created a comprehensive white paper outlining the market entry requirements and regulatory frameworks of 13 individual regions in a simple and easy to understand manner.

Global Information

As part of bringing this message to a global audience, SGS’ international team of medical devices experts travelled to Japan, Korea and Taiwan for a series of three educational events. The trip allowed us to connect directly with 350 delegates and discuss the challenges faced by manufacturers and other organisations in the medical devices supply chain. Topics ranged from specific market regulatory requirements for Russia, China, Saudi Arabia, the European Union, Japan, Taiwan, Brazil, the US and Canada; through to seminars on the Asian Harmonisation Working Party (AHWP), the International Medical Device Regulators Forum (IMDRF), life-cycle management related to medical devices software and the introduction of the EN 62304, and the clinical evaluation of medical devices.

Successful Symposia

The symposia proved very popular and offered the chance to exchange information in a relaxed and interactive environment. The delegates remarked on the scope, depth and relevance of the topics covered. For the future, we were asked by delegates to continue making available any new changes in medical device regulations. Our team are already working hard to make sure this successful first step is just the beginning of long-term education program from SGS.

Further Information

To download the SGS white paper mentioned in this article please visit the White Paper Library.

Contact the Medical Devices Team today to see how we can help your business. Kindly click on the “Email Us” link on this page.