Analysis of Medical Device Pre-Marketing Regulations in New Southbound Policy Countries and Taiwan
The management of medical devices is different from general products. Medical device firms must submit the documents to the competent authority for pre-marketing review before the products are released. The responsibility of competent authority is to confirm the safety, efficacy, and quality of the medical devices. In other words, the firms must follow the pre-marketing review regulations prescribed by the competent authority, moreover, medical device products couldn’t be launched on the market until they have met the management regulations of the country. Introducing the concept of medical device premarket management in this article might not only help industries to avoid breaking the rules, but also assist the vendors to expand marketing layout and reduce the export resistance, thus might promote the quality of medical service both in Taiwan and New Southbound Policy countries.