MDSAP Revision of Brazilian Regulatory Requirements

Date: 01 December

On May 2nd, 2022, RDC ANVISA n. 16/2013 - Good Manufacturing Practices and RDC ANVISA n. 23/2012 have been revised as follows: RDC ANVISA n. 665/2022 - Good Manufacturing Practices and RDC ANVISA n. 551/2021, with the transition period starting immediately.

Brazilian ANVISA Regulations

Making the transition to RDC ANVISA n. 665/2022 and RDC ANVISA n. 551/2021 – What do I need to do?

Here at BSI, we want to ensure that your transition to RDC ANVISA n. 665/2022 and n. 551/2021 runs as smoothly as possible – and we will be starting this process straight away.

Starting in 2023, transition audits will take place at your next scheduled MDSAP re-certification audit. If you would like to transition sooner during your next scheduled audit, please notify your BSI QMS auditor who will conduct your annual audit that you are ready to transition to RDC ANVISA n. 665/2022 and n. 551/2021. No additional time will be required to be added to your audit duration.

Once a recommendation has been made by the audit team and the MDSAP Regulatory Report goes through the independent review process, you will be issued a revised certificate with reference to the revised legislations RDC ANVISA n. 665/2022 and n. 551/2021. Certificate expiry dates will not be impacted by this transition and your on-going audit cycles will remain the same.

If you have questions or concerns about your business’ transition to RDC ANVISA n. 665/2022 and RDC ANVISA n. 551/2021 please refer to our MDSAP web page, where we will continue to share updates on vital changes to the Medical Device Single Audit Program.

Please be aware, if you choose to transition during a surveillance audit, you will incur a certificate reissuance fee. A certification reissuance fee is applied when your certificate is changed and re-issued. If multiple changes are captured during a single audit, a single re-issuance fee will be charged.

Alternatively, further information can always be provided via your BSI Account Manager – so please don’t hesitate to get in touch.

*Note: You may choose to transition to both the revised Brazil regulations and Japan regulations (see Client Communication MDSAP Revision of MHLW MO 169) during the same audit.