INFO KGV | LIFE SCIENCES MARCH 2019

ANVISA SIMPLIFIES REGULARISATION PROCEDURE FOR LOW RISK MEDICAL DEVICES

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Giovanna Pasquini Malfatti, Kestener Granja e Vieira Advogados

On 1 March 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 270/2019 (Portuguese Language), which simplifies regularisation procedures for Class I (low risk) medical devices, including in vitro diagnostics medical devices.

According to the Resolution, Class I medical devices are no longer required to register with ANVISA. This means that the devices will not be subject to ANVISA’s technical evaluation prior to manufacturing and selling, which will significantly streamline the process. Companies will only be required to notify ANVISA prior to marketing the device and ANVISA will subsequently publish the notification number within 30 days. Upon ANVISA’s publication of the notification number, the company will be able to manufacture and sell the device.

The Resolution will enter into force on May 2nd, 2019.

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

FEDERAL JUSTICE ASSURES PROVISION FOR CANNABIS-BASED DRUGS IN THE BRAZILIAN UNIFIED HEALTH SYSTEM

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Leonardo Barboni Rosa, Kestener Granja e Vieira Advogados

On 18 February 2019, the Federal Justice ordered the Ministry of Health to incorporate any and all cannabis-based drugs approved by the Brazilian Health Surveillance Agency (ANVISA) into the list of drugs provided by the Brazilian Unified Health System (SUS).

Previously, patients that needed SUS-financed treatment with cannabis-based drugs were required to seek judicial relief to import cannabis-based drugs, upon proof of the necessity of treatment with the drug.

Following the Federal Justice’s decision (Portuguese language), the SUS is obliged to regularly provide all approved cannabis-based drugs to patients with a valid prescription. The decision was rendered in a class action filed by the Federal Prosecutor’s Office and is subject to review by the Federal Court.

Currently, according to the decision, there is only one cannabis-based drug approved by ANVISA. The recent Federal Justice’s decision goes further by specifying the inclusion of all cannabis-based drugs that may eventually be approved in the future.

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