‘ if ap Republic of Sudan ¢ +» Federal Ministry of Yiay scans th ae Requirements for the registration of ‘Cae National Medicines & _ edical Devices (Human and Veterinary) Poisons Board Secretariat General A. General Requirements: 1. The manufacturing plants should be registered within the NMPB records. 2. The application form should be filled by the applicant. 3. The prescribed fees should be paid (if required). 4, All documents should be in English and/ or Arabic. B. Specific Requirements: 1. Registration requirements of human medical devices: a) Submit one of the following certificates: i. EC certificate compatible with the classification of medical device, ii. | US Food and Drug Administration (FDA approval), iii. Certificate of registration in a country with a stringent regulatory authority IMDRI countries) b) Submit medical device description, specification, and intended use, c) Submit the internal and external label of medical device, 2. Registration requirements of veterinary medical devices: a) Submit one of the following certificates: i. Free sale certificate ii. Certificate of registration in a country with a stringent regulatory authority IMDRI"* countries) b) Submit medical device description, specification, and intended use, c) Submit the internal and external label of medical device (the label must clearly state that the medical device is for veterinary use only). ~ . ° “ >. _public of Sen IMDRF* = International Medical Device Regulators Forum ©. "sv erg22 % w, % uss ti tne Gencral Secretariat National Medicines and Poisons Board a A Eh oe a a aa Code. No RMd/R/01/01. Issue. NO (3) Issue Date 01/08/2019 Change. NO () Change Date/ / Expire date01/08/2022 Page 1of1