Regulation for Registration of Medical Devices Article 3

For all registrations mentioned in the preceding article, the applicant shall pay the application fee and submit completed application forms with all required documents pursuant to this Regulation to the central health competent authority for approval.The application forms referred to in the foregoing Paragraph include application form for the registration and market approval of medical devices, application form for change of registration, application form for extension of permit license validity, affidavit, form for attaching outer box instruction label, and other form and document formats associated with the application procedures.If the documents submitted for an application filed in accordance with this Regulation are not in traditional Chinese or English, a traditional Chinese or English translation shall be additionally provided.