Brazil – Draft technical regulation on requirements for registration of medical devices and their reuse prohibition, labelling and use instructions

Brazilian Health Regulatory Agency (Anvisa) has issued draft Technical Resolution no 257, 28 September 2016 (Resolução RDC nº 257, de 28 de setembro de 2016), regarding the requirements for registration of medical devices and also their reuse prohibition, labelling and use instructions.

The manufacturers and importers of medical devices which hold valid registration in Brazil has the period of 1 (one) year to request to ANVISA, from the date of publication of this Resolution, changes needed to adequacy for labelling and use instructions, mentioned on articles 10 to 14 of this Resolution.

This Resolution revokes the Resolution RDC 156/2006 and the Specific Resolution RE 2.605/2006.

Proposed date of adoption: On the date of publication

Proposed date of entry into force: On the date of publication

Final date for comments: 5 December 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.