Inmetro communicated to the product certification bodies (OCP) on Friday, 29 July 2016, the postponement and alteration/corrections of the essay established in the Caput of Art. 5 ° to Art. 10 and content of the carrier Inmetro 54/2016, which assesses the conformity of equipment under sanitary surveillance (medical devices).
In the light of the need for the elaboration of guidelines and corrections of the carrier Inmetro N º 054/2016, the Inmetro divulged the stakeholders the draft of the text that will be published in public consultation, in this way we orient our customers of the segment of Equipment under the Health Surveillance Scheme (medical practitioners) to be aware of the main changes and key dates.
31 December 2016 – The certification processes in progress or initiated by December 2016 shall be completed by 31 December 2017, and may be carried out in accordance with the requirements of the Inmetro carrier No. 350/2010.
January 1, 2017 – New certification procedures and the recertification of equipment under the health surveillance scheme contracted from 1 January 2017 must conform to the requirements of the new carrier.
-OCP should inform Inmetro and ANVISA of the design modifications that critically affect the safety of the equipment under health surveillance already certified that are identified in audits and have not been informed by the manufacturer to OCP.
31 December 2017 – manufacturers and importers with certificates issued according to the provisions of Inmetro N º 350/2010 must conform to the requirements approved by this new carrier, to carry out recertifications that are contracted after 31 December 2017.
-a deadline for the issuance of new certificates or recertifications according to the carrier Inmetro n ° 350/2010.
-The validity of certificates issued by 31 December 2017 as the Inmetro 350/2010 would remain the same, of five (5) years.
The draft of the resolution can be found here, not yet an official document has been published, but once we have access to this it will be released for knowledge.
We have already thanked all our clients and we have made ourselves available for further clarification.