Scott Sardeson, Manager of International Regulatory Affairs at 3M USA, recently conducted a workshop on trends in global medical device regulations in Sri Lanka attended by participants from relevant organizations in the country. The Health Care division of 3M’s global network works closely with the industry and relevant authorities through various international organizations, the company’s [...]

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3M global Health Care expert conducts workshop in Sri Lanka

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Scott Sardeson, Manager of International Regulatory Affairs at 3M USA, recently conducted a workshop on trends in global medical device regulations in Sri Lanka attended by participants from relevant organizations in the country.

The Health Care division of 3M’s global network works closely with the industry and relevant authorities through various international organizations, the company’s Sri Lanka office said. The workshop focused on regulatory harmonization trends and the history of medical device regulations globally with specific reference to the work of the Global Harmonisation Task Force – GHTF (which is made up of industry and regulatory agencies) in a bid to achieve greater uniformity between national medical device regulatory systems.

“The ASEAN region is trying to harmonise and work towards a common model through the system of classification which is of utmost importance,” noted Mr Sardeson. “It is important to classify medical devices at different risk levels and in line with harmonized international practices. If we look at countries like Singapore and Australia, we will see that they already have what is known as harmonised or standardised models and systems in place”.

He said that Sri Lanka can benefit from harmonized regulatory practices through safe products entering the market while unsafe products will be filtered out. Through harmonization, Sri Lanka can also compete on a global scale as it would allow easier trade among countries, he added.

Scott Sardeson

3M is a global manufacturing company of which the Health Care division supplies medical devices and products to over 65 countries. Mr Sardeson explained that the company has identified the benefits of harmonization and utilizes its expertise towards designing products to global specification standards.

The company’s goal is to conduct more workshops in the future and work with a broader, more targeted audience. “The response for the workshop was good and the participants were very receptive,” he said. “We hope that we can continue to have these dialogues in the future and increase stakeholder engagement in Sri Lanka”.




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