Brazil market access - INMETRO Certification for Medical Devices
All medical devices intended for sale in Brazil must be registered with the Agencia Nacional Vigilancia de Sanitaria (ANVISA). The medical device registration process includes some basic requirements. Manufacturers must submit their application for the ANVISA Good Manufacturing Practice (GMP) audit. Once the GMP audit is complete, the first stage is submission of technical documents to be sent directly to ANVISA. Secondly, electromedical devices falling under the scope of IEC 60601-1 plus other non-electrical devices as required by ANVISA must be certified by an INMETRO accredited test agency and display the INMETRO marking.
UL is an INMETRO accredited test agency for medical equipment and can provide the mandatory product certification and factory inspections required by the regulations.
In order to maintain their certification, manufacturers located outside of Brazil are subject to an annual surveillance assessment. The annual surveillance assessment is based on ISO 13485 plus demonstration of the completion of routine production tests of the medical device. This evaluation must be performed by the certification agency irrespective of any ISO registration held by the manufacturer.
All medical devices shipped to Brazil are checked by Brazilian Customs against the ANVISA medical database for registration requirements and are allowed to enter Brazil only if properly registered.
The UL-BR Mark can help simplify your access to the Brazilian market. Once your product is certified, it will bear the INMETRO mark as well as the UL-BR Mark. These processes can be merged with your existing UL testing and regulatory surveillance audit assessments.
INMETRO 3rd edition of IEC 60601
Under RDC No. 27 and Instruction IN-3, the 3rd edition of the IEC 60601-1 is now acceptable in Brazil for INMETRO certification. This is a significant change from RCD No. 32 which omitted the 3rd edition of IEC 60601-1 from the Brazilian certification scheme.
New requirements for syringes, needles and infusion sets
In December 2011, additional devices falling under the general categories of syringes, needles and infusion sets were added to the list of medical products required to have INMETRO certification. The deadline for compliance is June 2013. In addition to the initial factory inspection, these devices will need to undergo batch testing to NBR and ISO standards at an ILAC accredited laboratory. These test reports are then analyzed by UL experts and if they pass, then, UL will issue the INMETRO certificate.
Advantage to using UL for Brazil INMETRO Certification
- UL taps into its global resources to provide your inspections from a local contact
- UL can provide both test reports that meet both Brazil and other country requirements to both 2nd and 3rd editions of IEC 60601.
- UL has experts on the ground in Brazil who are active in the committees and can help our customers predict changes in legislation and help interpret requirements
- UL can provide complete testing to applicable IEC/NBR 60601 collateral and particular standards including EMC and Software evaluations as required by INMETRO
Additional resources
- *NEW* White Paper "Medical Device Approvals in Brazil - A Review and Update"
- View on-demand webinar - "Overview of INMETRO Certification for Medical Devices in Brazil (IACET credits apply)
- View on-demand webinar on the regulatory system in South America
- Link to Dedicated web page to 60601 3rd edition
- Request an information sheet on UL's INMETRO certification services for medical devices
