INFO KGV | LIFE SCIENCES JANUARY 2019

ANVISA LAUNCHES PUBLIC CONSULTATION ON REUSABLE AND DISPOSABLE MEDICAL DEVICES

 

On 8 January 2019, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No. 584/2018 (Portuguese language), proposing a specific resolution in order to set out a new classification for reusable or disposable medical devices.

 

Currently, reusable and disposable medical devices are regulated through Resolution RDC No. 156/2006 (Portuguese language), which sets out the registration procedures, and labelling and reprocessing requirements for medical devices, and through Resolution RE No. 2,605/2006, which establishes a list of single-use medical devices.

 

Key aspects introduced by the proposed resolution include:

 

• Requiring the registration holder to classify, under technical justification, the product as reusable or disposable.
• Allowing healthcare providers to reprocess devices for other companies (however, the trading of reprocessed devices will continue to be forbidden).
• Placing liability on the healthcare provider and the reprocessor for the safety of the reused device (the existing rule only holds the healthcare provider responsible).
• Simplifying the labelling of reusable and disposable medical devices.

 

Responses to the Public Consultation must be submitted by 9 March 2019 via ANVISA’s website (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.”

 

RESTRICTION ON OUTSOURCING QUALITY CONTROL OF IMPORTED DRUGS

 

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

 

On 18 December 2018, the Brazilian Health Surveillance Agency (ANVISA), published Resolution RDC No. 257/2018 (Portuguese language), suspending some of the updated quality control outsourcing rules that were introduced by Resolution RDC No. 234/2018 (Portuguese language) on 25 June 2018.

 

Resolution RDC No. 234/2018 revoked a series of important restrictions on outsourcing by drug manufacturers and importers (see Legal update, New rules on production and quality control outsourcing). One of the effects of Resolution RDC No. 234/2018 was the possibility of outsourcing the quality control of imported drugs to a third party.

 

However, Resolution RDC No. 257/2018 restores this specific restriction: importers are again obliged to perform in their own quality control tests. According to the new Resolution, the suspension will be in place for two years and is necessary for the performance of a regulatory impact assessment on the modifications introduced by RDC No. 234/2018 on imported drugs.

 

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