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Could anyone help me for the following questions on Egypt In Vitro Diagnostics Medical Devices Registration ?
1. I only found the Draft of Medical Device Regulations in EDA website, but it shall not apply to IVDD. Has this draft been effective?
2. Has the regulation for IVDD been issued and effective? Or IVDD don?t need to be registered in Egypt?
3. Will IVDD need to get Import release, before import into Egypt?
4. Is Central Administration of Pharmaceutical Affairs (CAPA) only for product registration?
5. Is Drug Policy and Planning Center (DPPC) only for import release?
Thanks in advance!
1. I only found the Draft of Medical Device Regulations in EDA website, but it shall not apply to IVDD. Has this draft been effective?
2. Has the regulation for IVDD been issued and effective? Or IVDD don?t need to be registered in Egypt?
3. Will IVDD need to get Import release, before import into Egypt?
4. Is Central Administration of Pharmaceutical Affairs (CAPA) only for product registration?
5. Is Drug Policy and Planning Center (DPPC) only for import release?
Thanks in advance!
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