CAPA(Central Administration for Pharmaceutical Affairs) is responsible of medical devices regulations in Egypt.
All medical devices should be registered.
CMC can help you to go through the registration process.
Steps of registration process
1. You need to have a local representative in Egypt
2. Prepare a list of products you want to register for submission (within 1 year)
3. Prepare registration file for submission
4. CAPA reviewing the files
5. You can start to import class IIa, IIb and class III non sterile products in the process of registration
6. For sterile single use products, the manufacturer will need to wait for the registration number to import
7. The registration is valid for 10 years
8. If your products are high risk devices, the manufacturer should provide a post-market surveillance each 2 years
All medical devices should have ISO 13485 and should comply with the implemented QMS for quality management.
Documentation can be accepted in English, including labelling.
You should notified the Egyptian MOH about any changes you make in your products, such as, manufacturing process, company address, company name, packaging sizes, sterilization method, changes in products's shelf life, addition of products or codes.
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