As of May 1, 2017 Ordinance 54 has replaced Ordinance 350. Under the Ordinance, there are increased requirements for audited processes including all items from ISO 13485 and items related to the project of the product, for instance the Risk Management analysis at manufacturer facility.
The certificates issued under Ordinance 350 will not be impacted for the new Ordinance, unless the Certification body, INMETRO or ANVISA identified any change into the project with critical impact on the safety of the device. In this case the currently certificate shall be cancelled and a new certification process according under the new Ordinance 54 will be required.
According to the transition, Certification Bodies have until April 30, 2018 to issue certificates under Ordinance 350 which means that on April 30, 2023, the last of these certificates will hit the 5-year expiration date.
INMETRO 3.1 edition of IEC 60601
Under RDC No. 27 and Instruction IN-4, the 3.1 edition of the IEC 60601-1 is mandatory in Brazil for INMETRO certification.
Advantage to using UL for Brazil INMETRO Certification
- UL is an ILAC accredited laboratory and can accept test reports from other ILAC accredited labs
- 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
- 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
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.
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 Certification for medical devices is good for 5 years and requires:
- Testing at or by an ILAC accredited laboratory to applicable IEC 60601 based ABNT NBR standards
- Quality system audit based on ISO 13485*
- Witness of product production/assembly of each representative product family models on site by an INMETRO auditor
- Routine production tests conducted on 100% of the products bearing INMETRO certification
- Regular surveillance audits
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**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.