Smallest Sales Unit Vs. Registration Unit


Smallest sales unit and registration unit are two different concepts. As part of the registration dossier, NMPA requires manufacturers to provide the label sample of the smallest sales unit. We usually need to modify the label as per NMPA requirements.
Takeaway:NMPA has a guideline for the determination of a registration unit for medical device registration. Do not confuse the concepts of the smallest sales unit with the registration unit.