Taiwan’s Pharmaceutical Affairs Act regulates both pharmaceutical products and medical devices. Under the provisions of the Act, medical device manufacturers seeking access to the Taiwan market must obtain a license for the manufacture or selling of medical devices, and have their devices reviewed and approved by the Taiwan Food and Drug Administration (TFDA) and the Department of Health (DOH). Documentation required in support of a medical device review and approval varies based on the degree of risk the device poses to humans.
At a minimum, most manufacturers are required to submit a detailed company description, a description of their production process and, most important, quality system documentation (QSD) that meets Taiwan’s good manufacturing practice (GMP) requirements. QSD must be audited and certified by an independent third-party. Prior certification to ISO 13485, is accepted in some cases as evidence of compliance with Taiwan’s QSD/GMP requirements, and may streamline the device review and approval process.
Taiwan and the European Union (EU) have entered into a technical cooperation program, which can also facilitate access to the Taiwan market for medical devices that have received prior EU approval.