On 2 October 2017, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 179/2017, which amends RDC No. 39/2013, to implement a new work methodology concerning inspections for Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Storage Practices (GSP) certifications to enable Brazilian companies to import medical devices from international manufacturers. The revised procedure allows ANVISA to carry out a prior risk assessment to select and prioritise inspections to be performed.

The authorisation process to import the products requires the inspection of the manufacturer’s facilities by ANVISA. Instead of placing all companies requesting GMP, GDP and GSP certifications in the same automated queue for international inspection, ANVISA will have the ability to select and prioritise them according to varied criteria such as:

• The level of risk of the product.
• Technology involved in their manufacture.
• ANVISA’s operational capacity to carry out the inspections.

Resolution RDC No. 179/2017 allows ANVISA to use:

• A valid audit report issued by accredited and recognised third auditor entities from the manufacturer’s country which attests the fulfillment of the good practices for medical devices established by Resolution RDC No. 16/2013.
• Technical documents related to the quality assurance system of the company and that confirm compliance with the good practices, issued by the competent regulatory agency of the country in which the manufacturer is located or accredited third auditor entities.

The new methodology potentially reduces the time that Brazilian importers will need to obtain authorisation to import medical devices. It is hoped that the shorter waiting time for GMP, GDP and GSP certifications (and therefore, for the registration of the products before ANVISA) will give the Brazilian population faster access to new technologies.

Source: ANVISA RDC No. 179/2017, 27 September 2017 (Portuguese language); and ANVISA RDC No. 39/2013, 14 August 2013 (Portuguese language).

Anvisa updates clinical trial inspection procedure

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Bruno Fontes Muniz, Kestener Granja e Vieira Advogados

On 3 October 2017, the Brazilian Health Surveillance Agency (ANVISA) published the Normative Rulings No. 20/2017 and 21/2017 which regulate the inspection procedure of Good Clinical Practices (GCP) on clinical trials involving the study of, respectively, drugs and medical devices.

The Normative Rulings provide inspection proceedings that allow ANVISA to verify GCP compliance of clinical trial sponsors. For example, ANVISA can request the sponsor of any clinical trial to provide clarification in relation to any instances of potential non-compliance. After that, if some non-compliance in the clinical trial is confirmed, ANVISA may (i) interrupt the trial; (ii) cancel the trial in a specific test center or nationally; or (iii) invalidate the data resulting from it.

The Normative Rulings provide new relevant regulation on clinical trials, establishing clearer and stricter rules on their inspection procedures.

Source: ANVISA: Inspection of clinical trials is updated, 3 October 2017 (Portuguese Language); Ministry of Health: Normative Ruling No. 20/2017, 2 October 2017 (Portuguese Language); Ministry of Health: Normative Ruling No. 21/2017, 2 October 2017 (Portuguese Language)

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”