ANVISA to Allow Medical Device Firms to Evaluate Their Inspections

Regulatory NewsRegulatory News | 18 November 2014 |  By 

Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

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.

Firms 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 perhaps show 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.


Original Post: Emergo Group

Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification

Related Post: New Regulation in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices


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