Brazil - Anvisa Resolution RDC 349/2020 with Alternative Procedures for Registration of Personal Protective Equipment, Medical Equipment (Pulmonary Ventilator) and Other Medical Devices Due to COVID-19 Epidemic

​The Anvisa (Brazilian Health Agency) issued the Resolution RDC 349/2020 with extraordinary and temporary criteria and procedures for the treatment of requests for registration of personal protective equipment (PPE), medical equipment (pulmonary ventilator) and other medical devices identified as strategic by Anvisa, due to the emergence of international public health resulting from the new Coronavirus.

The registration of medical devices will follow the instructions from Anvisa Resolution RDC 185/2001 with:

- Exemption of Anvisa GMP Certificate, replaced by Medical Device Single Audit Program (MDSAP) Certification or ISO 13485 Certificate;

- Exemption of medical device Inmetro certification.

The Anvisa registration under these conditions will be valid for 1 year.

The surgical masks, PFF2 and N95, which have a Certificate of Approval issued by the Ministry of Economy (PPE Regulatory Authority) are now authorized for use in health services during the term of this Resolution.

The Resolution RDC 349/2020 is valid for 180 days after its publication date in the Official Gazette, March 20th 2020.