Guidelines For Registration Of Medical Devices or Supplies

Medical supplies such as surgical dressings, surgical ligatures and sutures are standardized in many pharmacopeias and other monographs. The provisions of the medical supplies acts of many countries stipulate that this category of products comply with the quality specifications set for them. In view of this international trend, the Drug Administration and Control Authority of Ethiopia has prepared this guideline. The purpose of the guideline is to provide manufacturers with information concerning documentation to be submitted for approval and registration of the categories of products covered by this guideline. The guideline consists of two sections, each section covering different class of products. Section I outlines sets of data which should be submitted along with an application for the first registration of surgical dressings, whereas section II enumerates requirements for the registration of surgical ligatures and sutures. Some sub-sections of this guideline are cross referenced with the ‘’Guideline on the Requirements for the registration of drugs for human use, July, 1996 edition. Consequently, the later guideline is to be considered as complementary to the former and users of this guideline are advised to use it in conjunction with the above guideline for the registration of human drugs. It is also to be understood that all applications submitted to the Drug Control and Administration Authority should be original and in the English language. When any part of the document, except the package labeling, is originally written in another language, a legalized translation into the English language must be submitted along with the original version.