Brazil issues additional regulations on anti-epidemic supplies

With the further intensification of the global epidemic, the shortage of masks and protective clothing has intensified, and governments of various countries have gradually introduced relevant emergency authorization policies, such as the EU authorization related simple access mechanism, the United States and France accept or conditionally accept mask products that meet equivalent Chinese standards, etc. . At present, Brazil and Belgium have also issued additional regulations and alternative testing programs. SICE has compiled a comprehensive list of countries' recent dynamic access policies for anti-epidemic materials to help companies make corresponding adjustments in a timely manner.
 
Medical devices and in vitro diagnostic devices are supervised by the Brazilian National Health Inspection Agency (ANVISA). In response to the COVID-19 outbreak, ANVISA issued additional regulations RDC 346/2020, RDC 348/2020 and RDC 349/2020 for equipment related to COVID-19 or SARS-CoV-2.
 
According to RDC N°349: The relevant registration documents that need to be provided are registered with ANVISA for medical equipment, priority processing; For the case where the manufacturing company has not obtained the Good Manufacturing Practice certificate issued by ANVISA, the Medical Device Single Audit Plan (MDSAP) will be specially replaced Certification or ISO 13485 quality management system certification;
 
According to RDC 356/2020: Anti-particle masks for medical use, such as FFP2, N95 are temporarily exempt from authorization and registration;
 
 Applicable technical standards:
01 Surgical mask
I-ABNT NBR 15052: 2004-Non-woven fabrics for dentistry and hospitals-Surgical masks-Requirements
II-ABNT NBR 14873:2002 Dentistry-Medical-Non woven fabrics for hospitals-Determination of bacterial filtration efficiency
The particle filtration efficiency (EFP) of filter elements must be greater than 98% , Bacterial filtration efficiency (BFE) must be greater than 95%
02 N95 and Class 2 particulate filter respirator (PFF)
I-ABNT NBR 13698:2011-Respiratory protection equipment-half surface part of the filter particles
II-ABNT NBR 13697:2010-Respiratory system protective equipment-Particulate filter, the main technical parameters are the same as EN 149 FFP2
03 Hospital clothing:
I-ABNT NBR ISO 13688:2017-Protective clothing-General requirements
II-ABNT NBR 16064:2016- Textile health products-Surgical drapes, aprons and clean room clothes used by patients, medical staff and equipment
III-ABNT NBR 14873:2002-Non-woven fabrics for dental, medical and hospital products-Determination of bacterial filtration efficiency
IV-ISO 16693: 2018-Health Textiles-


Anvisa, an apron and personal clothing used by medical staff and patients for non-surgical procedures, simplifies the requirements for manufacturing, importing and purchasing priority medical equipment for healthcare services. According to the rules, manufacturers and importers will obtain the company's provisional operating permit (AFE) and notification of activities to Anvisa and other health permits, which are exceptions and temporary exemptions.  
This move is driven by the current international public health emergency related to Covid-19. This rule   came into effect in the   University Council (RDC) Resolution No. 356/2020, effective from the date of publication of the Official Gazette (DOU) (Monday/23/3). The validity period is six months.  
Products considered in the new regulations include surgical masks, goggles, face shields, N95 gas masks, PFF2 or equivalent disposable hospital clothing (waterproof and non-waterproof aprons/cloaks). Products such as valves, hats and props (disposable shoes), as well as breathing circuits and connection devices are also on the list. 
Responsibility 
Anvisa informed that the rule did not exempt the company from other obligations. Manufacturers and importers of products must comply with other requirements applicable to the control of medical devices and technical standards related to the product. The company should also carry out post-marketing control (monitoring after commercialization).  
The agency emphasized that the manufacturer or importer has the responsibility to ensure the quality, safety and effectiveness of the products manufactured in accordance with Brazilian regulations.