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Tag: ANVISA

Posted on 24 November 202024 November 2020

BRAZIL: Cadastro eliminated also for Class II medical devices

On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the …

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Posted on 20 April 202020 April 2020

BRAZIL: new rules for medical devices design changes

Recently ANVISA has published two regulations RDC 340/2020 and IN 61/2020, introducing from April 1, 2020 new classification rules for …

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Posted on 18 March 201921 March 2019

BRAZIL: new ANVISA notification pathway for Class I medical devices

To streamline the market access for low-risk medical devices, on March 1, 2019, the Brazilian Regulatory Authority ANVISA (Agencia Nacional …

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Posted on 16 March 2018

BRAZIL: Brazilian manufacturers may apply for MDSAP certification

The MDSAP (Medical Device Single Audit Program) certification can finally be requested by manufacturers based in Brazil or in other …

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Posted on 13 February 20181 March 2018

BRAZIL: good news for medical devices and IVDs

The 10-year extension of certificates validity for high-risk Class III and IV devices and IVDs registered in Brazil is already effective. …

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+ How to register radiation emitting medical devices with the CDRH

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+ MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”?

  • What is the “period of grace” and how can I take advantage of it?

  • What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?

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+ IVDR (EU) 2017/746

  • What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

  • When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?

  • How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?

  • What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • What is the “sell off” provision?

  • Transitional period: can in vitro diagnostic medical devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

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