Quality System Requirements: B-GMP Following classification and BRH selection (as well as INMETRO c

Quality System Requirements: B-GMP
Following classification and BRH selection (as well as INMETRO certification, if necessary), manufacturers must ensure compliance with Brazilian quality management system (QMS) requirements.

Although most emerging market regulators recognize U.S. Food and Drug Administration (FDA) Quality System Requirements compliance or ISO 13485 certification, Brazil has established its own QMS—Brazilian Good Manufacturing Practice (B-GMP).

All Class III and IV medical devices, as well as Class I and II devices listed in Normative Instruction (IN) 2/2011, must comply with B-GMP. Although B-GMP requirements resemble those of the FDA’s Quality System Requirements, manufacturers should not assume that FDA compliance translates seamlessly to B-GMP compliance. Manufacturers formerly were subject to B-GMP quality system inspections and fees on an annual inspection schedule. Now, B-GMP inspections are conducted on a biennial basis.
(During off years, manufacturers must conduct internal quality inspections and submit results to ANVISA.) Class I and II devices that do not appear on IN 2/2011 do not require B-GMP certification; manufacturers of these devices thus face lower compliance costs because they do not have to deal with the expenses of quality system implementation and ANVISA inspections.

Manufacturers should be aware that there currently is a two-year lead time for GMP inspections, and therefore should plan accordingly. ANVISA currently is processing GMP requests from June 2010.