title: [Preselection procedure for medical devices suppliers at the essential medicines and generic drugs purchasing central in Togo (CAMEG-Togo)].
abstract: One of the main objectives of pharmaceutical policies in developing countries is to ensure accessibility and affordability of good quality medicines for the population. The Essential Medicines and Generic Drugs Purchasing Central (French acronym, CAMEG-Togo) is a not-for-profit association established in 1998 to ensure procurement for public and not-for-profit private public health facilities within the framework of recovery of costs. Although attention has been focused mainly on medicines, medical devices account for a growing part of the pharmaceutical products purchased by central stores, hospitals and health programs. Recognizing this need in 2002, CAMEG-Togo in collaboration with the French cooperation agency decided to upgrade its competency in evaluating the quality of medical devices. For that purpose the information sheet used to preselect suppliers for international tenders and the technical specifications sheet for medical devices was revised and pharmacists responsible for processing these files were given specific training. European directive N 93/42/CEE of 14 June 1993 is currently used by CAMEG-Togo as the regulatory basis for preselection of medical device suppliers. Referencing based on American regulatory requirements is now under way to widen the scope of suppliers eligible for preselection. The purpose of this article is first to describe the main guidelines of the European directive used by medical device manufacturers to obtain EC certification and second to present the procedures used by the CAMEG-Togo to preselect medical device suppliers, with special focus on the technical specifications sheet.
authors.affiliation: CAMEG, Lomé, Togo. mbabaley@cafe.tg
authors.forename: M
authors.initials: M
authors.lastname: Babaley
mesh_terms: D018954:Drugs, Essential; D016568:Drugs, Generic; D004864:Equipment and Supplies / Q000600:supply & distribution*; D005062:European Union; D040541:Marketing / Q000331:legislation & jurisprudence*; D009939:Organizations, Nonprofit; D014037:Togo
chemical_list: D018954:Drugs, Essential; D016568:Drugs, Generic