GMP for Medical Devices - ANVISA's Inspection Guide

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

The Brazilian monitoring authority ANVISA is also responsible for medical devices. It published a "Resolution" No.59  with GMP requirements for medical devices ("Establish and implement requirements for Good Manufacturing Practice of establishments that manufacture or market medical devices"). These GMP requirements are very similar to those used by the FDA for medical devices (21 CFR 820, Quality System Regulations, QSR). It is interesting to notice that the document contains a part B on "Quality System Requirements"  which is a 8-page check list divided into 4 medical devices classes (low to high risk potential) with regard to the ANVISA GMP requirements. As the Brazilian GMP provisions are very similar to the US American ones, the inspection check list may also be useful for companies who want to export in the USA.

Click here to access the Resolution 59 with the inspection check list.