Medical Devices Act Article 29

Regulations governing the following related matters shall be established by the central competent authority:1. Requirements, procedures, and review guidelines in regard to the application for registration and market approval and issuance of license or listing of medical devices in accordance with the provisions of Article 25.2. Requirements and procedures in regard to the application for alteration of the particulars of registration and market approval or listing in accordance with the provisions of Article 26.3. Procedures in regard to the application for extension, replacement, and re-issuance of licenses in accordance with the provisions of Article 27.4. Procedures in regard to the annual declaration in accordance with the provisions of the preceding article.