The document includes:
1. Academic and theoretical bases, relevant research reports and data.
2. Clinical evaluation report or clinical trial report.

    The central competent authority shall determine or announce whether or not the medical device applying for registration and market approval requires clinical trials in the Republic of China (Taiwan) by considering the medical device product item, individual case, and data submitted by applicant.

    For medical devices with predicate device(s) that have been approved for marketing in Taiwan, unless it is necessary to verify their safety and effectiveness with clinical evidence, this document may be exempt from submission.

    For Class 2 medical devices without predicate device, unless otherwise specified, the clinical trial report may be replaced by supporting data that meets all the following conditions:
1. There are no ethnic differences in the expected effectiveness of this product.
2. There are no serious adverse reports related to the claimed intended use or indication for such type of product in foreign countries, and the product has not been required to be removed from the market.
3. Preclinical data (including trial) may be used to demonstrate that the differences between the product and domestic products that have been approved for marketing will not affect the product's safety and effectiveness; or marketing approval certification documents of the United States of America and the European Union may be provided and the indication under application does not exceed the scope approved by the United States of America and the European Union.