Why choose QR Consulting as your Registration Holder?5 de novembro de 2018
Assuntos Regulatórios12 de maio de 2019
Regulation: Companies that want to sell Class III and IV medical devices or IVDs in Brazil must be
certified by ANVISA (GMP certification). The requirements for medical devices are specified in
Brazilian resolution RDC 16/2013 and MDSAP model.
B-GMP inspections prior to registration approval: In order to be in compliance with Brazilian
requirements, you must submit a GMP Certificate to start the registration of Class III or IV
registration. GMP certification requires an inspection by ANVISA (onsite inspection). ANVISA will
only approve device registrations after successful completion of a GMP audit.
QR Consulting can help you complying with Brazilian QMS requirements
Complete a thorough gap assessment to evaluate your current level of compliance performing
on-site audit in preparation for your BGMP inspection.
Help modify your existing QMS to meet Brazilian GMP requirement.
Provide on-site support during ANVISA's inspection of your quality system.