Medical Devices ImportersN Opinions on Classification of Medical Devices By Risk Level

Abstract

Introduction: Thailand made changes on classification of medical devices as ruled by ASEAN Agreement on Medical Device Directive (AMDD). This agreement has an affect directly on the medical device importers. Objectives: To study opinions of medical devices importers towards the classification of medical devices by risk level in terms of concerns, effects, and solutions. Methods: This is a qualitative research that collected data by in-depth interviewing from 10 key informants. A semi-structured interview were used as data collecting tool. The collected data then analyzed by content analysis method. Results: All of medical device importers concerned that there will be changes from the government about classification of medical devices, a timing affect on registering medical products as well as governmentas official workforce. This new classification of medical devices would lead to a higher costs. However, medical devices importers are wellprepared for the new rule. They have informed the headquarter office about the new classification of medical devices. Moreover, they support the Thai government to reclassify the medical devices based on the risks. Conclusion: The study shows that medical devices importers are concerned about the reclassification of medical devices. Nevertheless, they are prepared for the changes coming in the near future. Moreover, they expect that this classification will improve Thailandas medical device standards to meet international standards. The results of this study can be helpful for government policy-makers in order to reduce affects on reclassifying medical devices