“Approved once, accepted everywhere” – main idea for EEU medical regulatory affairs.
Expected regulation for all medical devices has a lot of unknowns:
1. Harmonization – base of acceptance criteria- is still in process.
2. Classification rules for medical devices – different for each country for this moment and only Russia has clear nomenclature (4n classification rules).
3. Acceptance process as well as which country could be chosen as reference country (question – how to receive one registration certificate for all countries from the first submission).
All of this expecting to be solved soon – if new regulation scheme starts from January it is lack of time to delay with these questions due to possible collapse in approvals for healthcare products.
See EAC MED for details.