All medical devices imported or distributed in Brazil must be registered with ANVISA. However, only companies based in Brazil can apply directly for ANVISA registration. Manufacturers without a subsidiary in Brazil which intend to place medical devices on the market there must obtain representation by a Brazilian Registration Holder (BRH) recognised by ANVISA. The responsibility for submitting the application for approval together with the technical documentation with ANVISA rests with the BRH. Resolution RDC 185/01 sets forth the requirements regarding the content of the technical documentation to be submitted.
Only test reports from organisations that are accredited by members of internationally recognised forums such as IAF or ILAC are accepted for INMETRO certification. Approved devices are issued an INMETRO certificate and are authorised to display the INMETRO certification mark.
Before most electrical medical devices and some non active medical devices can be registered with ANVISA, they must be certified by a certification body accredited by INMETRO. A factory inspection prior to certification is also required. In order to maintain the INMETRO certification, annual factory inspections have to be carried out.
All medical devices in classes III and IV (comparable to classes IIb and III in accordance with 93/42/EEC) are subjected to Brazilian GMP (BGMP) inspections carried out exclusively by ANVISA in two-year intervals. In June 2011, ANVISA published Normative Instruction (IN) 2/2011 on medical devices in classes I and II (comparable to classes I and IIa in accordance with 93/42/EEC), which are also covered by the biennial BGMP inspections. Any medical devices in classes I and II not included in this Normative Instruction are excluded from inspections.
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