Marcio GodoyDITTAStandardizationWorkingGroupMember
ABIMEDRepresentative
DITTAWorkshoponInternationalStandardsFlorianópolis,12September2016
ThesituationofBraziliancompaniesregardingtheimplementationof
standardsinBrazil
AGENDA
Ø ANVISARESOLUTIONRDC27:2011
Ø ANVISANORMATIVEINSTRUCTION04:2015
Ø THEKEYELEMENTSOFINMETROORDINANCE54:2016
ANVISARESOLUTIONRDC27:2011
ANVISARESOLUTIONRDC 27:2011
• Makes provisions on the procedures for the mandatory certification ofequipment subject to Health Surveillance system.
• The equipment shall prove compliance with Resolution RDC 56:2001, which"establishes the essential safety and effectiveness requirements for healthcareproducts” by means of the certification of conformity within the scope of theBrazilian Compliance Assessment System (SBAC).
• In order to comply with the provisions set forth in this resolution, therequirements contained in ANVISA Normative Instruction 04:2015, or theamendments shall be taken into account.
ANVISANORMATIVEINSTRUCTION04:2015
ANVISANORMATIVEINSTRUCTION 04:2015
IN 04:2015 updates compliance timeframes for various IEC 60601 standards. Themajor updates are included in the new instruction:
1) The implementation of standards listed on Annex I shall be conditional upon aqualified Brazilian testing labs is able to perform the tests.
2) If any standard listed in Annex I of this NI will be canceled, this will still berequired in the certification process until a new NI is released.
3) if any standard listed in Annex I of this NI will be replaced by an updatedversion, it can be used, although the compulsory version is the one presented inthis NI. This updated revision shall be taken mandatory into a new NI is released ifthere is a qualified Brazilian testing lab.
ANVISANORMATIVEINSTRUCTION 04:2015
4) Certification process is not applicable to IVD products because the rulesrelated to those products are not listed in this Normative Instruction.
IEC 60601-1 Edition 3.1
Regulators Deadline for compliance
ANVISA 24 Sep 2015
FDA 01 Aug 2016
European Commission 01 Jan 2018
ANVISANORMATIVEINSTRUCTION 04:2015
5) ABNT IEC 60601-1-9:2014 (Portuguese translation of IEC 60601-1-9:2013) willbe mandatory starting 01/Dec/2016. Only clauses 4.1, 4.5.2 and 4.5.3 need to beevaluated and the manufacturer does not need to provide a ILAC accredited testreport according to it.Note: This same approach has been used for IEC 60601-1-6 (Usability)
IEC 60601-1-9
Regulators Deadline for compliance
ANVISA 01 Dec 2016
FDA Not recognized
European Commission Not harmonized
THEKEYELEMENTSOFINMETRO ORDINANCE54:2016
INMETRO ORDINANCE54:2016
INMETRO ORDINANCE54:2016
The main changes that will take effect from 31 December 2016 withOrdinance:
• Increasing the number of items to be examined during the audit of theQMS, as Annex A to the Ordinance No. 54:2016;
• The audit of importers, record holders and registration, certificationrequestors, to assess the QMS in compliance with the requirementsABNT NBR ISO 13485:2004 according to Table 8 of Annex B ofOrdinance No. 54:2016 and compliance with item 7 – RGCP theComplaints Handling;
INMETRO ORDINANCE54:2016
Requirement Description Standard RequirementControl of documents 4.2.3Control of records 4.2.4Customers communication 7.2.3Verification of purchased product 7.4.3Identification and traceability 7.5.3Preservation of product 7.5.5Control of monitoring and measuring devices 7.6Customer satisfaction 8.2.1Control of nonconforming product 8.3Corrective Action 8.5.2
INMETRO ORDINANCE54:2016
• To elaborate the Test planning, which shall establish the test requiredfor the product’s Compliance Evaluation. The Risk Management Fileshall be minimally accompanied, among other documents, if applicable,of:
INMETRO ORDINANCE54:2016
INMETRO ORDINANCE54:2016
OBRIGADO!THANK YOU!
