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METIZ certifications

What the certifications reported by METIZ mean: ISO 13485, ISO 9001, CE Declaration under the MDR, EUDAMED registration and SFDA certificate.

Short answer: METIZ reports five certifications: ISO 13485 and ISO 9001 for the quality system, the CE Declaration of Conformity under the European medical device regulation, registration in the European EUDAMED database and a certificate from Saudi Arabia's health authority.

Seals: EU MDR, ISO 13485, ISO 9001, SFDA, EUDAMED and CE

ISO 13485

International standard for a quality management system, made for medical device manufacturers. It covers design, production, traceability and product risk control.

ISO 9001

International standard for a quality management system, valid for any sector. It organizes a company's processes, records and continuous improvement.

CE Declaration under the MDR

The MDR is Regulation (EU) 2017/745, which governs medical devices sold in the European Union. The CE Declaration of Conformity is the document in which the manufacturer states that the product complies with this regulation.

EUDAMED

European medical device database. METIZ reports that it is registered there as a manufacturer, together with its products.

SFDA

The Saudi Food and Drug Authority, which regulates medical devices in Saudi Arabia. The certificate allows the components to be sold in the Saudi market.

And in Brazil?

In Brazil, medical devices are regulated by Anvisa, the national health regulatory agency. For purchase documentation, public tenders or agreements, ask the Metiz Brasil team for the registration or notification number of each component and for copies of the certificates.

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Sources

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