August 27, 2020
Overview
We can provide both test reports that meet Brazilian and other countries’ requirements, and we have experts on the ground in Brazil who are active in the committees to help you predict changes in legislation and interpret requirements.
We can provide complete testing to applicable International Electrotechnical Commission (IEC)/NBR 60601 collateral and particular standards, including electromagnetic compatibility (EMC) and software evaluations as required by National Institute of Metrology, Standardization and Industrial Quality (INMETRO).
Ordinance 54
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 International Organization for Standardization (ISO) 13485 and items related to the project of the product, for instance the Risk Management analysis at a manufacturer facility.
The certificates issued under Ordinance 350 will not be impacted for the new ordinance, unless the Certification body, INMETRO or National Health Surveillance Agency (ANVISA) identified any change to the project with critical impact on the safety of the device. In that case, the current 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.
Benefits
INMETRO certification for medical devices is good for five years and requires:
- Testing at or by an ILAC accredited laboratory to applicable IEC 60601 based Brazilian Association of Technical Standards (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 percent of the products bearing INMETRO certification
- Regular surveillance audits
*Note: 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.
Why UL
We are an International Laboratory Accreditation Cooperation (ILAC) accredited laboratory and can accept test reports from other ILAC accredited laboratories, tapping into our global resources to provide you with inspections from a local contact.