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Monsicha Boonsiri

Monsicha Boonsiri is a Regulatory Affairs Officer in Baker McKenzie Bangkok office.

The Food and Drug Administration has recently updated a number of regulations related to certain medical devices to ensure that they are carefully monitored and controlled, have prescribed quality standards, and are safe for consumers. The updated regulations relate to alcohol detecting devices, positive airway pressure devices and dentistry devices.

To promote and support research and development of medical devices in Thailand, the Ministry of Public Health and the Food and Drug Administration have recently issued several notifications providing additional guidance for manufacturers or importers of certain medical devices seeking exemptions from licensing requirements (i.e., the manufacturing or import license, and the product registration license) under the Medical Device Act.

Join the regulatory affairs specialists in our Bangkok office’s Healthcare & Life Sciences Industry Group at this insightful webinar to get an overview of the key issues which you should consider when undertaking a regulatory compliance audit as applicable to pharmaceuticals, medical devices, foods and cosmetics (including considerations based on recent legal updates), as well as the steps that may be taken to ensure you stay compliant and avoid unnecessary pitfalls.