Re: Medical Equipment Inmetro Certification Process in Brazil
4.4. licensed company
„The licensed company is the manufacturer or the importer of the product.”
è only the Brazilian importer/distributor or we (the manufacturer) or both ? - Taking into consideration items 7 (complaint handling), 8.3 (Traceability) and 10 (especially technical and penal responsibility), I assume that only the Brazilian importer/distributor can be the licensed company.
Only Brazilian entities.
n 6.1.1.1 Application for init. Assessm.
- which exact technical documentation has to be submitted ?
- what happens first: initial audit or initial type test ? à Taking into consideration item 6.1.1.4, I assume that the initial audit happens first, because 6.1.1.4 states that after the assessment of 6.1.1.2 (solicitation) the audit must be scheduled. (And the type test by recognition of test reports can happen subsequently).
The generic and formal process is that the audit is first (besides what you mentioned, there´s also a need for the OCP to get a sample). But this process is not always followed. For example, sometimes the tests are being performed long before the initical contact with the OCP.
Each OCP requires specific documentation, but generally they are related to technical information about the product, maybe some test reports if they are already done, and certificates if any.
- „After launched production line the OCP must validate these product(s)”
è prototypes which have already been tested must be validated by the OCP after launched production line à which validations/tests must be performed in this case ? Routine tests acc. to Annex A or further technical documentation or both ?
Both. The idea is the OCP have top be sure that the prototype reflects the final device. It´might even be possible that some additional type testing is needed.
6.1.1.3.1.3 / 6.1.1.3.1.3.1 (initial type test)
Are there meant only the changes which have an impact on the conformity ?
In principle yes, but in fact changes in general are being sctrutinizing at the moment due to a requirement by Anvisa (this new portaria was made more complex and with a lot of additional requirements because of problems rtelated to design changes). Another problem is there´s no guidance at the moment detailing what are changes that need to be taken into account. I´m chairing a study group to develop a guidance document on significat changes related to Portaria 350, we hope to have an initial draft soon.
n 6.1.1.5 Issuing of Conformity Certificate
- analyzing item 6.1.1.5.5.1, OEM– and supplier-manufacturing sites must be audited as well. Can these points also be audited at the PLM (legal manufacturer) e.g. by document review (supplier contracts etc.) ?
No, this is the same problem as with the Anvisa GMP inspections...the audit must be performed at the manufacturing site, if it´s a third party, then it must be done there.
9.4. Suspensão, cancelamento ou renovação da autorização
“…. happens if none of the requirements of this RAC is met..” ßàwhat exactly is meant by this phrase ?: none or not all ?
Not all. In the original, it´s "any".
9.4.4 states that for the recertification the type tests must be done again if:
- Age of (IEC-) report used for initial type test/conformity- assessment ≥ 5 years
à even if the applicable standards have not been revised/changed ?
- Standard(s) applied for initial type test changed / revised
è even if the change/revision of the standards does not impact the “initial conformity” ?
- Change which has an impact of the type‘s previously assessed conformity
è even if according to item 6.1.2.2.1.4 it has been decided during a maintenance assessment that in despite of the impact on the conformity there were no new type tests necessary?
In the case of a recertification, it´s focused on a time-base, so you will need in 5 years to have a new test report anyway. This is as always was, meaning Anvisa was worried that in 5 years there "must" be changes......almost a police state
....anyway, in a recent meeting of the Certification Committee Anvisa was very open to review timeline requirements (our main worry at the moment is the 2 years test report for initial certification) so there´s might be some change to this in the future.
n 10.1 p)
Does the conformity mark has to be printed in the commercial presentation (catalog etc. ?) or what does 10.1 p) mean ?
In principle only on the device, but there´s an Inmetro regulation wich details control of their conformity marking.
14. „ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO“
What may be the reason for the “ENCERRAMENTO DO PROCESSO DE CERTIFICAÇÃO” / what is the intention of section 14 ?
When you stop manufacturing a technology/device.
If the documentation which has to be submitted for the solicitation and during the audit is not available in Portuguese/English: how does this affect the success of the certification ?
Greatly. At least english is a must.