E-ssentials MedDev Blog

Regulatory updates for the medical device industry

Brazil: INMETRO certification according to the new Ordinance 54/2016

INMETRO, the certification scheme for medical electrical equipment for the largest medical-device market in Latin America, has been governed exclusively by Ordinance 54/2016 since 1 May 2018. As a result, certification requirements have become significantly more rigorous than under its predecessor, Ordinance 350/2010. The new requirements focus more than ever before on risk management and the criteria defined in the ISO 13485 standard. The ordinance introduces significantly extended requirements for review of the risk-management documentation and the technical documentation as well as for factory inspection.

The applicable standards

As in the past, factory inspection according to Ordinance 54/2016 still focuses on the applicant’s quality management system. Its evaluation is based primarily on the ABNT NBR ISO 13485:2004 standard and ANVISA resolution (Resolução) RDC No. 16/2013. However, quality evaluation also focuses on other national standards, including ABNT NBR IEC 60601-1/2010, ABNT NBR IEC 60601-1-6/2011, ABNT NBR IEC 62366 and ABNT NBR IEC 60601-1-9/2010. But don’t be too discouraged: the corresponding international ISO and IEC standards can be applied as an alternative. Nevertheless, the requirements are relatively extensive and will overall cause efforts and expenses to rise significantly.

To make the process as effective as possible, TÜV SÜD provides a regional contact partner who offers support throughout the certification process. You therefore have a local contact partner who is familiar with the requirements of Ordinance 54 and takes over the coordination of your entire project.

Your ticket for Brazil

How to prepare ideally for certification right from the start:

  1. First, familiarise yourself with the basic requirements (Ordinance 54/2016 and Normative Instruction No. 4, 24 September 2015).
  2. Start planning the necessary tests and preparing the documentation at an early stage!
    Please note that proof of compliance with ABNT NBR IEC 60601-1-6/2011 and ABNT NBR IEC 60601-1-9/2010 can be furnished directly by the manufacturer. In other words, there is no need for you to obtain test reports from an accredited laboratory.
  3. Schedule more time for factory inspection under the new ordinance than you did for factory inspection according to the old Ordinance 350/2010.
  4. Check with your TÜV SÜD contact to see whether INMETRO factory inspection can be combined with other audits, for example according to ISO 13485 or NRTL (Nationally Recognized Testing Laboratory).

internal code: 20NOV2018_TÜV SÜD Product Service GmbH_PS_MKG_MHS_blog_1.0_en_DE

Georg Bauer

Georg Bauer

Department Manager Foreign Affairs

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