July 28, 2021
Brazil’s National Institute of Metrology, Standardization and Industrial Quality (INMETRO) issued Ordinance No. 200/2021 on April 29, 2021. This ordinance establishes a major revision to the General Product Certification Requirements (RGCP), revoking previous Ordinances Nos. 118/2015, 250/2016, 252/2016 and 176/2017.
The new RGCP underlies all Conformity Assessment Requirements (RACs) henceforth
The new RGCP, which took effect on June 1, 2021, constitutes part of an ongoing initiative by INMETRO to reduce bureaucratic inefficiency for certification processes in the Brazilian market. One of the key changes of this revision is to expand the scope of Conformity Assessment Requirements (RACs) that use the RGCP as their basis. In particular, the following RACs that did not previously mention the RGCP are required to base certification issuance and request activities on it.
- Certificate of conformity
- Activities performed by OCP accredited by an International Accreditation Forum Multilateral Recognition Agreement (IAF MLA) member
- Certification transfer
- Certification closure
- Conformity identification seal
- Authorization to use the conformity identification seal
- Responsibility and obligations
- Market monitoring
- Annex B – Certification Transfer – exclusively in cases of omission
- Annex C – Additional Criteria for Certificate Issuance
QMS requirements update and transition period
The new version of the RGCP also updates the version of the quality management system (QMS) requirements that factory audits are designed to verify. It makes the certification’s closure process a mandatory step and more clearly defines the criteria for issuing all certificates, as outlined in Annex C.
Ordinance No. 200/2021 provides for a six-month transition period for certification process updates, after which they must all be comply with the new RGCP. Following this period, the entire scope of products designated for compulsory certification in Brazil will fall under the umbrella of the RGCP, thus unifying the general requirements for product certification processes.
Get help with INMETRO certification
UL is an INMETRO accredited test agency and certification body for medical equipment and can perform factory inspections. The UL-BR Mark can help streamline access to the Brazilian market. Find out more about how UL can help.