The growing healthcare market in Brazil is raising high expectations, also among German manufacturers of Medical Devices. However, the approval procedure there – in particular, that for Active Medical Devices – has its pitfalls. Before manufacturers can register their Medical Devices with the Brazilian health surveillance agency ANVISA (Agência Nacional de Vigilância Sanitária) they need INMETRO (Instituto Nacional de Metrologia, Normalização E Qualidade Industrial) certification.
The approval procedure at a glance:
Phase 1: Representative and classification
Foreign manufacturers need an in-country representative recognized by ANVISA to register their devices with the authority. Brazil‘s classification rules are very similar to those specified in Annex IX to the MDD. Careful attention is required right from step one, which may impact on the duration of registration process and thus on market planning.
Phase 2: INMETRO certification
Most Active and some Non-Active Medical Devices need INMETRO certification before they can be registered with ANVISA. Within the scope of this certification, test reports must be submitted. Generally, IEC test reports created for CE approval or other purposes are recognized, provided they were prepared by a testing laboratory accredited by an ILAC member. In some cases there are national deviations and manufacturers must prove in additional tests that their products comply with these national deviations. INMETRO certification further requires factory inspection at the manufacturer. Factory inspection must be carried out at annual intervals.
Phase 3: ANVISA Inspection
The manufacturer‘s quality management system is also inspected and evaluated. It must be in compliance with the BGMP (Brazilian Good Manufacturing Practice). BGMP compliance is verified in BGMP inspections that must always be carried out by ANVISA. These inspections are conducted every two years and generally take four to five days. ANVISA does not authorise any inspections carried out by third-party organizations such as TÜV SÜD.
Phase 4: Registration by ANVISA
Together with the INMETRO certification and the ANVISA inspection certificate, manufacturers must submit complete technical documentation for registration. Generally, the technical documentation prepared for CE approval in Europe is sufficient. The associated test reports must not date back more than two years. From January 2014, the 3rd Edition of the IEC 60601-1 standard will apply exclusively. Usually, ANVISA does accept clinical studies performed outside Brazil.
Stakeholders wishing to register their products on the Brazilian market must also provide evidence that their products are approved in the country of origin or in other markets. For some Medical Devices, manufacturers must submit an economic information report containing information about device pricing in other countries, the number of patients using the device, the expected life and other details.
The duration of the registration process in Brazil essentially depends on two phases. Up to two years can pass between the filing of the application and execution for a first inspection with ANVISA. Depending on the device‘s risk and complexity, the review at ANVISA may take between six and twelve months. Given this, a total period of three years can pass before a new device can be placed on the market in Brazil. The validity of registration is restricted to five years.
Accreditation by ILAC members
The testing laboratories of TÜV SÜD recently obtained DAkkS accreditation. As the DAkkS is a member of ILAC, our clients‘ test reports are accepted for INMETRO certification. The same applies to the testing laboratories of Singapore-based TÜV SÜD PSB (SAC as ILAC member) and TÜV SÜD America (A2LA and NVLAP as ILAC members).