Brazil medical device QA/RA blog

News and commentary on regulatory changes.

ANVISA to Allow Medical Device Firms to Evaluate their Inspections

Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.

BGMP inspection feedback program from ANVISA for medical device comapniesFirms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA providing their perspective on how their quality system inspections went, and what could be improved.

For the time being, the evaluation program is meant only for investigational purposes, but does show perhaps willingness by Brazilian regulators to take more industry feedback into consideration during the BGMP inspection process over the longer term. 

Learn more about Brazilian registration and BGMP compliance here.

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