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The only CA for IMPs and MDs is the Medical Products Agency (MPA).
Whether clinical trials with tissue or cell therapy will require a submission to the CA depends on the degree of manipulation and on the commercial potential of the “product”. A technique being offered by a specialist clinic provided at a certain hospital may be regulated by the National Board of Health and Welfare only (transplantation). If the technique or procedure is likely to be marketed, it will be regulated by the MPA and requires approval like a medicinal product.
There is an option to create a system within the hospital for a specific patient, or for a group of patients, e.g. a new machine for renal dialysis. It is assumed that this is not research, but within the hospital clinical practise (a sort of “named patient basis”).