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Hello,
My company is a manufacturer of combination products considered medical devices incorporating a medicinal product in Europe i.e. the only part of the CTD we require is Module 3. We are interested in registering the devie in South Africa but it seems the device because it incorporates a medicinal product is considered a drug and all 5 modules of the CTD must be compiled and submitted. Is this the case? Can anyone offer any insight on how to proceed i.e. is it possible to rationalise why only Module 3 is submitted or is it necessary to compile all modules etc.
Any help or guidance would be much appreciated.
Thanks!!
My company is a manufacturer of combination products considered medical devices incorporating a medicinal product in Europe i.e. the only part of the CTD we require is Module 3. We are interested in registering the devie in South Africa but it seems the device because it incorporates a medicinal product is considered a drug and all 5 modules of the CTD must be compiled and submitted. Is this the case? Can anyone offer any insight on how to proceed i.e. is it possible to rationalise why only Module 3 is submitted or is it necessary to compile all modules etc.
Any help or guidance would be much appreciated.
Thanks!!