Derived from the Public Consultation of July 1st, 2014, Portaria 170 is being complemented with Portaria No. 407 of August 21st, 2015. The attached document shows the comparison table with the new dispositions and changes. It is noteworthy that Portaria 170 is still fully applicable.
In summary, the main changes are:
1. Introduction of the Definition of Highly Specialized Devices.
2. CB scheme laboratories will now be accepted and existing reports will be permitted as long as it is demonstrated that the device continues to be the same.
3. New period of validity of the conformity certificate: 3 years.
4. Highly specialized devices will be exempt from testing, during the maintenance, as long as they continue to be the same (same design and critical components).
5. Maintenance is required after 12 months and recertification after 36 months.
6. The evaluation of recertification must be done every 36 months and must consider the results of the documents’ conformity, recertification audit of the quality system, and the test plan for recertification.
The certificates issued before this Portaria 407 continue with the 2-year validity as well as the maintenance requirements.