Brazilian Medical Device Regulators Moving to Electronic Submission System
ANVISA, Brazil’s medical device marker regulator, has announced plans to begin accepting electronic submissions of registration documents from manufacturers.
Update June 28, 2016: ANVISA has published RDC 86/2016 (link in Portuguese), its final rule on electronic submission requirements, as well as an accompanying normative instructions.
The new ANVISA proposal (link in Portuguese) would allow Brazilian medical device market registrants to assemble and submit their application materials faster and at lower cost; currently, applicants must print all submission documents to present to ANVISA reviewers.
Once the new proposal is published, there will be a year-long (365 days) transition period, after which ANVISA will accept submissions via electronic media including CD and DVD as well as e-CNPL certificates. Brazilian market applicants will still need to submit printed applications during the transition period.
According to RDC 86/2016 and accompanying IN 08/2016, electronically submitted registration documents will have to be provided on CD-ROM or DVD-ROM media, with digital signatures from legal representatives included. Documents will have to be provided in PDF format, with a resolution of 300 dpi and in file sizes no larger than 600MB.