On September 9, 2023, the new RTCR 505: 2022: BIOMEDICAL EQUIPMENT AND MATERIAL. CLASSIFICATION, REGISTRATION, IMPORT, LABELING, ADVERTISING, SURVEILLANCE, AND CONTROL came into effect, establishing requirements and procedures for the classification, registration, import, labeling, advertising, and surveillance of biomedical equipment and material.
Under this new regulation, the following documents, which were not previously requested by the authority for these types of procedures, are required:
- Manufacturing contract containing the following information:
