Please find below contact details
and contact us today! Our consultants are always ready to help you.
Please find below contact details
and contact us today! Our consultants are always ready to help you.
Imported in vitro diagnostic medical devices are required to be registered with DIGEMID before they are marketed in our country. This category includes diagnostic reagents used for clinical diagnosis in hematology, pathology, immunology, and nuclear medicine.
Registrations must be renewed every 5 years.
We will outline the optimal regulatory strategy for your products, according to their risk classification.
Evaluating technical and scientific documentation issued by the manufacturer.
Preparing a fully compliant registration dossier and submitting the registration application to DIGEMID through VUCE.
Follow-up of applications. Replying to inquiries and amendment requirements by DIGEMID reviewers.
Class I, II, III, and IV medical devices. Biomedical equipment, and electromedical systems.
Vitamins, enzymes, amino acids, herbal extracts, powders, and sweeteners.
IVD products, biochemistry analyzers, and reagents.