International Medical Device Registration

International Medical Device Registration A compilation of all the regulations affecting medical device registration world-wide Book edited by M. E. Donawa. Published by Interpharm... 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Medical devices are used for the diagnosis, monitoring, and treatment of almost every disease or condition. Due to their central role in clinical practice, medical devices require certification and registration prior to their placement on the market. Since IBSs are categorized as medical devices, they must meet certain legal requirements to be allowed to go to the market, in compliance with national and international regulations. 

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