News

Notice to NCC Customers: Public Consultation No. 17, May 8, 2025

Dear Customers,

We inform you that Public Consultation No. 17, dated May 8, 2025, published in the Official Gazette, proposes amendments to Inmetro Ordinance No. 200/2020 (General Product Certification Regulation - RGCP). Below, we summarize the main proposed changes, aimed at aligning certification processes with new requirements, impacting manufacturers, suppliers, and Product Certification Bodies (OCP). The consultation is open for contributions until July 8, 2025, as specified at the following link: Public Consultation No. 17.

Key Proposed Changes:

1. Compliance with Requirements and Deadlines:
   • Certification processes must be adjusted at the next maintenance or recertification, with a minimum period of 6 months. If shorter, adjustments may occur in the subsequent evaluation stage.
   • A 12-month period is set for updating seals involving changes to tooling (high/low relief marking).
2. Reference Documents (Item 3):
   • Inclusion of standards such as ISO/IEC TR 17026 (type 5 certification scheme), ABNT NBR 5426 (batch sampling), and Inmetro Ordinance No. 282/2020 (risk classification).
   • Mandatory use of the latest versions of referenced documents, with a 12-month adjustment period, except for errata or immediate-effect corrections.
3. Definitions (Item 4):
   • New definitions for Risk Analysis, Family, Model, and Commercial Model, detailing criteria to identify new products or versions based on changes affecting performance, purpose, or risk.
4. Technical Documentation (Item 6):
   • Requires detailed information, including model/family identification, technical description, photos (min. 800x600 dpi), risk analysis, production processes, ISO 9001 certificates (if applicable), Portuguese manual, among others.
   • Documentation in languages other than English or Spanish must be translated into Portuguese.
   • Suppliers must provide additional data, such as CNPJ, articles of incorporation, and information on complaint handling.
5. Audits and Testing (Items 6.2.3 and 6.2.4):
   • Changes in the production process must be reported to the OCP, potentially requiring a new audit.
   • Previous test reports (max. 1 year) may be accepted for certification models 2, 3, 4, and 5, provided they meet traceability and accreditation criteria.
   • Compliance with international standards (e.g., ISO/IEC) has a 24-month adjustment period or as stipulated by the standard.
6. Non-Conformities (Items 6.2.4.2 and 6.2.5.3):
   • Batches with non-conformities require a critical analysis of process/design failures. Reprocessing is allowed for issues related to markings or manuals.
   • Non-conformity handling must include cause analysis, immediate corrections, and corrective actions, with records submitted to the OCP.
7. Certificate of Conformity (Item 6.2.6.3):
   • Must include model/family identification, brands, and traceability (batch, manufacturing date, or serial number).
   • Unique numbering with a variable component per certification cycle.
8. Maintenance and Recertification (Items 6.3 and 6.4):
   • Extraordinary audits/tests may be conducted without prior notice if non-conformity is suspected.
   • Maintenance frequency may be reduced (from 6 to 12 months or 12 to 24 months) for low-risk products (I/II or III with model 5), provided robust risk analysis and no non-conformities are recorded.
   • Recertification tests may be waived from the 2nd cycle for low-risk products under specific conditions.
9. Special Cases (Item 6.5):
   • For custom or non-serial production, batch certification (model 1b) is permitted, with sampling per ABNT NBR 5426.
10. Complaint Handling (Item 7):
    • Complaint handling audits may be conducted remotely.
11. Conformity Identification Seal (Item 11):
    • Requires the certificate number for products without Object Registration.
    • Allows a QR Code linked to Inmetro’s ProdCert database.
12. Market Surveillance (Item 14):
    • Certificate holders must replace samples for inspection and provide information within 5 business days when requested.
13. Extraordinary Conditions (Annex E):
    • In cases of war, public calamity, or health emergencies, remote audits, remote sampling, and model 1b certification are permitted, with risk analysis and evidence recording.
14. Kit Certification (Annex B):
    • Establishes criteria for repackaging or kit assembly, requiring a new seal with the packager’s identification or retention of the original seal with the statement “Contains products registered with Inmetro.”

Recommended Action:

We recommend that NCC customers thoroughly review the full Public Consultation document, available at the link above, and submit contributions by July 8, 2025. The proposed changes significantly impact certification processes, documentation, risk analysis, and traceability, requiring special attention.

Exclusive Webinar: Once the new RGCP is published, we will hold a webinar to discuss the changes and their implications. Stay tuned for details!

For any questions or support, our team is at your disposal.

Best regards,
NCC Team