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Are Remote Audits an option when accessing the Brazilian medical device market?

Date: 05/22/2020

Medical device manufacturers are providing life-saving equipment to care for patients who have been infected with the new coronavirus. But how do you conduct a third-party audit, required for market access, when most of us must work remotely? How the Brazilian Regulatory Agencies such as ANVISA and INMETRO are dealing with this?

Remote auditing is one of the audit methods described in ISO 19011:2018 Annex A1. The value of this method resides in its potential to provide flexibility to achieve the audit objectives. In order to accomplish that, all interested parties should be aware of their role in the process, inputs, expected outputs, risks and opportunities that will provide the basis to achieve the audit and audit program objectives.

The feasibility of remote audits using Information and Communication Technology (ICT) in accordance with ISO 19011:2018 should be considered when establishing the audit program. It is important to verify the adequacy of resources required to ensure an effective audit outcome. ISO 19011 – Annex A.1 provides several examples for the application of remote audit methods in combination with on-site methods, such as: “Remote audits refer to the use of ICT to gather information, interview an auditee, etc., when “face-to-face” methods are not possible or desired.”

IIAF MD 4 is another mandatory document for the use of ICT for audit/assessment purposes. It defines the rules that certification bodies and their auditors shall follow to ensure that ICT are used to optimize the efficiency and effectiveness of the audit/assessment, while supporting and maintaining the integrity of the audit process. Both ISO 19011 and IAF MD 4 should be known and considered by the auditors.

The ICT resources open the opportunity to audit sites and people remotely, shortening distances, reducing travel time, costs, and associated environmental impact , adapting audits to different organizational models. ICT can help increasing the size or quality of sampling in the audit process, when prepared, validated and used properly. Using video cameras, smart phones, tablets, drones or satellite image to verify physical settings such as pipe identification in the petroleum industry, machinery settings, storage areas, production processes or forest or agricultural sites, for example. Those resources have definitely transformed the way we work.

However, we must consider the limitations and risks posed by ICT in the fulfilment of audit objectives, such as information security, data protection and confidentiality issues, veracity and quality of the objective evidence collected, amongst others.

How are the Brazilian Regulatory Agencies dealing with this?

Due to the COVID-19 pandemic, all Notified Bodies accredited by CGCRE (INMETRO General Coordination for Accreditation) as a Certification Body (CB) for the local INMETRO-scheme to conduct medical devices approvals for Brazil are allowed to perform remote audits until the 30th of June, according to  INMETRO Ordinance 111:2020. The reshaped Ordinance will allow INMETRO medical devices certification for factories to be carried out anywhere in the world, making the process faster and more practical. But INMETRO’s Ordinance 111:2020 also postponed all certification deadlines in 06 months. So far almost all CBs in Brazil are using this 06-month deadline for internal adjustments, the majority did not have ICTs resources available, trained auditors and internal procedures to provide remote audits.

ANVISA’s RDC 346/2020, published on the 13th of March, stablished that the emergency use of remote inspection mechanisms will be temporary allowed (while the Resolution is in force – 180 days), replacing the on-site sanitary inspection for purposes of obtaining Brazilian Good Manufacturing Practices (GMP) Certification. Remote inspections are carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP.

At first, the alternative and temporary certification mechanisms described in the Resolution apply only to petitions submitted prior to the publication of this Resolution, with the exception of the request for GMP certification for medicines or medical devices intended for control, diagnosis, prevention or treatment of  the new Coronavirus OR essential products to maintain life. However, Resolution nº 385/2020, published on May 12th removed that restriction and opened the possibility of remote audits for other products and for petitions submitted after RDC 346/2020, while the Resolution is in force.

Therefore, ANVISA has taken actions to be aligned with this new reality concerning Certificate issuance for factories entering the Brazilian market during the 180 days-period established by RDC 346/2020. Moreover, they kept open the possibility of renewing those measures for equal and successive periods of 180 days, in case inspections by ANVISA are still unviable due to the pandemic scenario. INMETRO and ANVISA remote audits are likely to be more frequent in the coming months, but one big question remains. After the pandemic the Brazilian Regulatory Agencies will continue to authorize the use of remote audits? DOMO Salute team will remain attentive on the Brazilian Regulatory Agencies movements.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

This article was written by our Business Developer Maurício Avila. Maurício is a lead auditor for ISO13485 and MDSAP, through his career he has engaged in product certification and the standardization area, building up a deep understanding of the regulatory paths foreign companies can face entering the Brazilian market.

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