Registration Tracker Records
What is a record?
In RAMS, a record can be either a registration or a certificate for a medical device .
What is a medical device registration record?
A medical device registration record represents the approval that a manufacturer receives from a regulatory authority to sell a medical device in a country or market (e.g., the European Union).In many countries, medical device registrations have an expiration date by which they need to be renewed. It is the medical device manufacturer’s responsibility to renew the registration ahead of the expiration date.
In RAMS, one registration record represents the approval of a product in a country or market. A product can include multiple part numbers. (see figure 1.1)
What is a certificate record?
A certificate record represents a formal certification that a manufacturer employs general practices (e.g.implementing an effective quality management system) and/or developed a particular product in accordance with applicable industry standards and requirements (e.g., standards for electro-mechanical safety).
Some regulatory authorities require manufacturers to submit certificates together with their registration submissions as evidence of compliance with expected development practices. Similar to registrations, some certificates have an expiration date by which the certificate should be renewed. (see Figure 1.2)
Figure 1.1 Record- Product Registration
Figure 1.2 Record-Certificate