COMPREHENSIVE ADMINISTRATIO FOR THE COMPLIANCE MANUFACTURING AND MARKETING OF MEDICAL DEVICES IN MENA COUNTRIES

K. Swetha, GNA Lakshmi, Dr. V. Ramadoss, N. Audinarayana, Dr. Jothieswari*

During the development and registration process, several parties need to interact with each other. Local authorized representatives or agents play a key role in medical Devices registration in all MENA countries. They are required as per the regulations and they help to overcome barriers for foreign companies, like language issues and the know-how of local requirements and processes as well. Often websites and local regulations are only available in local language (mostly Arabic) and local agents can benefit from participation in local regulatory or industry networks. As the requirements for Medical Devices are not homogeneous throughout the MENA countries, different types of dossiers will have to be prepared. The technical documentation will cover the requirements of the majority of countries, however not internationally named as ‗design dossier‘ or STED. Beside the technical documentation, the main requirements are usually GMP or QM-System certificates, a FSC from the Country of Origin, a Letter of Authorization, EC certificates, and Declaration of Conformity, a Certificate of Analysis the finished product, a statement about the status of Devices distribution, a local application form and country specific declarations. The FSC is a key document in the registration process of Medical Devices in most MENA countries, which must be legalized by the chamber of commerce and the embassy of the foreign importing country in C.O.O. (see Annexes II, III and IV)). Annex II-IV illustrate which countries need a FSC for submission and which countries do not required a FSC. The Devices needs to be classified very early in the development process in order to determine the path forward. Medical Devices in general usually are divided into three groups as in the USA (class I, II and III) or four groups as in the EU (class I, IIa, IIb and III) or according to the GHTF guidelines (class A, B, C and D). The main MENA countries accept both EU and FDA definitions. In vitro diagnostic Devices are seen as a separate group and the classification of these products vary a lot.