Electronic Submissions for Medical Devices in Asia

Many regulatory authorities in Asian countries are choosing to allow medical device product registration submissions to be done in electronic form. Previously, all governments required product registration applications to be completed in paper form, however, technical advances and the advent of a more digital age has led many countries to accept applications in electronic format.

Currently, Asian countries that are accepting electronic submissions for medical devices include Singapore, Malaysia, Indonesia, and Vietnam. China and Taiwan have yet to implement the capabilities of accepting electronic submissions but are expected to do so in the near future. In Singapore, product registration submission forms can be completed in Microsoft Word format and submitted to the Health Sciences Authority, Singapore’s medical regulatory authority.